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3 TMS and tDCS for Major Depressive Disorder
39
Safety
The rTMS is generally considered a safe treatment modality for MDD, with a welldocumented safety prole derived from extensive research and clinical trials. The
most common adverse effects experienced during rTMS sessions include transient
discomfort at the site of stimulation, which may extend to nearby regions of the
face, such as the eye, ear, and jaw. Patients might also experience twitching or muscle contractions in these areas due to the excitation of supercial nerve branches.
Headaches can occur, particularly in the initial treatment sessions as individuals
adjust to the HF stimulation sensation. However, these adverse effects often diminish over time as patients habituate to the procedure.
Importantly, rTMS does not increase the risk of migraine headaches in healthy
individuals or those with a history of migraines. In fact, a specic device, Spring
TMS, has been cleared by the FDA for treating acute migraine. Strategies to mitigate discomfort include the use of over-the-counter analgesics, such as acetaminophen or ibuprofen, and topical anesthetics applied to the scalp prior to treatment.
Adjusting the amplitude of TMS pulses may also enhance tolerability, although the
antidepressant efcacy of lower intensities remains uncertain. Overall, while rTMS
is associated with some minor adverse effects, there is no evidence of harmful
changes to brain tissue when delivered within established safety parameters, making it a viable option for individuals with TRD.
Treatment Regimen
The treatment regimen for conventional rTMS involves several key components,
including the stimulation target, intensity, frequency, duration of each session, and
the total number of treatment sessions.
• Stimulation target: For HF (10Hz) rTMS, the primary stimulation target is the
left DLPFC, typically identied at the F3 electrode site using the 10–20 EEG
system. Conversely, LF (1Hz) rTMS targets the right DLPFC, generally at the
F4 electrode site.
• Stimulation intensity: The intensity of rTMS is often set at a percentage of the
patient’s motor threshold (MT), usually around 110% for 10Hz stimulation to
ensure effective neural activation. For 1Hz stimulation, the intensity is typically
lower, often around 90% of the MT, to achieve the desired inhibitory effects
without causing discomfort.
• Stimulation frequency: HF rTMS is delivered at 10Hz, while LF rTMS is deliv-
ered at 1Hz. This difference in frequency is strategically employed to either
enhance or inhibit neural activity in the targeted brain areas.
• Stimulation time: Each rTMS session usually lasts between 20 and 40 min,
depending on the specic protocol and patient tolerance.
• Number of treatment sequences: The overall treatment regimen typically consists
of daily sessions over a period of 4–6weeks, amounting to a total of approxi-
mately 20–30 treatment sessions. Adjustments may be made based on individual
patient responses and clinical considerations to optimize therapeutic outcomes.
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T. Zhang et al.
Clinical Recommendations
Conventional rTMS should be considered for broader clinical use in treating MDD,
whether as an adjunct to other therapies, as an augmentation strategy, or as a standalone treatment. Its ease of administration and the substantial body of clinical evidence supporting its efcacy make rTMS a practical option for clinicians. Given its
favorable safety prole and the exibility in treatment protocols, rTMS can be integrated into comprehensive treatment plans tailored to individual patient needs.
Clinicians are encouraged to utilize rTMS alongside pharmacotherapy and psychotherapy to enhance overall treatment outcomes. Regular monitoring and follow-up
assessments will ensure optimal patient care and allow for adjustments in treatment
strategies as necessary, ultimately improving the management of depression in
diverse patient populations. Notably, rTMS also offers distinct advantages in special
populations, such as adolescents and the elderly, where traditional treatments may
pose greater risks or be less effective.
Overall, level A evidence (denite efcacy) was applied to HF-rTMS of the left
DLPFC and level B evidence (probable efcacy) was applied to LF-rTMS of the
right DLPFC for MDD [22].
3.2.1.2 Bilateral rTMS
Efficacy
Bilateral rTMS is a new and promising way to treat MDD.A review of seven randomized controlled trials (RCTs) on using bilateral rTMS to treat MDD shows that
it is more effective than sham rTMS [23]. Bilateral rTMS was as effective as left and
right unilateral rTMS [24], demonstrating that bilateral rTMS is an effective
treatment.
Safety
The adverse effects associated with bilateral rTMS for MDD include a variety of
sensations such as anxiety, cognitive complaints, difculty sleeping, dizziness,
fatigue, feeling nauseous, headache, hypomania, lactation, lightheadedness, metallic taste, nightmares, pain, racing thoughts, scalp discomfort, tinnitus, worsening
mood, u [25–36]. The majority of these adverse effects are transient and typically
resolve after discontinuation of rTMS treatment. rTMS administration is contraindicated in patients with metallic implants or intracranial lead devices. Caution
should also be exercised when administering rTMS to patients taking medications
known to lower seizure thresholds.
Treatment Regimen
The bilateral rTMS approach involves the administration of LF stimulation to the
right DLPFC and HF stimulation to the left DLPFC within the same treatment session. Specically, 600 pulses at 1Hz to the right DLPFC followed by 1500 pulses
3 TMS and tDCS for Major Depressive Disorder
41
at 10Hz to the left DLPFC: 5 times per week for 3weeks for a total of 15 treatments
according to the study by Blumberger etal. [26].
Clinical Recommendations
In Blumberger etal.’s study, only bilateral rTMS produced signicantly greater antidepressant effects than sham [26]. It is therefore recommended that bilateral rTMS
protocols over the DLPFC (LF on the right side and HF on the left side) be considered as a probable antidepressant treatment (level B evidence) for patients with
MDD [22].
3.2.1.3 Accelerated rTMS
Efficacy
To enhance the antidepressant response and reduce the number of stimulation days,
it has been suggested that increasing the number of rTMS sessions per day (more
than one daily session) might be more effective [37]. The main goal of accelerated
rTMS protocols is to reduce the patient and operator burden of repeated sessions
over several weeks. A systematic review and meta-analysis suggested that accelerated rTMS could improve the severity of depressive symptoms [38].
Safety
Accelerated rTMS protocols appear to be safe and well tolerated in depressed
patients [38], even in the elderly [39]. Common adverse effects include headache,
malaise, nausea, and dizziness. A small number of patients may experience moderate to severe adverse effects, including functional impairment [39].
Treatment Regimen
In the accelerated rTMS protocol of Fitzgerald etal. [40], patients received three
treatments per day for 3days in week 1. In week 2, three treatments were given over
2days, and in week 3, three treatments were given on a single day. In the three daily
treatment sessions, 83, 83, and 84 trains of 10Hz rTMS were delivered to the left
DLPFC, respectively. 4.2-s trains were delivered at 120% of resting MT with a 15-s
intertrain interval (10,500 pulses per day across the three sessions for a total of
63,000 pulses). Sessions were 15–30min apart. And in the study by Loo etal. [37],
two treatment sessions were given on each day of the week, separated by 2h, stimulation parameters per session were 10Hz, 30 trains of 5s duration, 25s between
trains, at 110% of the subject’s MT.
Clinical Recommendations
Although evidence supports similar efcacy of accelerated rTMS protocols and
rTMS protocols with only one stimulation session per day [40] and in favor of sham
stimulation [37], it is premature to recommend the use of accelerated rTMS protocols for the treatment of MDD.
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T. Zhang et al.
3.2.2 Deep TMS
3.2.2.1 Efficacy
Deep TMS presents a compelling rationale for treating depression by targeting
deeper brain structures that are often involved in mood regulation. Unlike traditional TMS, which primarily affects supercial cortical areas, deep TMS is designed
to reach deeper nuclei, such as the subcallosal cingulate and ventral striatum. This
ability to penetrate deeper into the brain allows for a more comprehensive modulation of the neural circuits associated with MDD.
One of the key mechanisms by which deep TMS operates is through its impact
on neurotransmitter systems situated within these deeper nuclei. By stimulating
these areas, deep TMS can signicantly enhance the release of serotonin, dopamine,
and norepinephrine, neurotransmitters that are essential for mood stabilization. This
targeted stimulation of deeper structures facilitates a more profound therapeutic
effect, potentially leading to greater symptom relief than supercial stimulation
alone [41].
Recent ndings from a study [42] utilizing resting-state quantitative EEG
(QEEG) highlight the neurophysiological changes resulting from deep TMS.The
study demonstrated a reduction in slow-frequency brain activity (delta and theta
waves) in the prefrontal cortex following 36 treatment sessions. This attenuation of
slow-wave brain activity may be a critical factor in how deep TMS alleviates depressive symptoms. Notably, baseline QEEG measures predicted treatment response
with 93% accuracy, suggesting a strong link between neurophysiological markers
and therapeutic outcomes.
Moreover, deep TMS is particularly effective in promoting neuroplasticity within
the deeper brain regions. This is crucial for patients with depression, as they often
exhibit reduced neuroplasticity. By directly stimulating deeper nuclei, deep TMS
encourages the formation of new neural connections and enhances synaptic strength.
This process of neurogenesis is vital for long-term improvements in mood and cognitive function, making deep TMS a powerful tool in the treatment of MDD.
Finally, the noninvasive nature of deep TMS enhances its attractiveness as a
treatment option for those who may not respond to traditional therapies. Its capability to reach deeper brain structures while minimizing effects on surrounding tissues
underscores its therapeutic potential, establishing a solid rationale for its use in
managing depression effectively.
The deep TMS demonstrates signicant efcacy in the treatment of depression.
The systematic review [43] indicates that deep TMS shows strong clinical efcacy
in patients with MDD, particularly among those who are resistant to traditional
treatment. This therapeutic method effectively modulates neural networks associated with mood by stimulating deeper regions of the brain.
Multiple clinical trials comparing deep TMS to sham treatment have shown that
patients receiving deep TMS experience signicantly better outcomes in terms of
symptom relief. For instance, studies report marked improvements in remission and
response rates among deep TMS-treated patients. These ndings highlight deep
3 TMS and tDCS for Major Depressive Disorder
43
TMS as a promising alternative therapy, especially for individuals who do not
respond well to conventional pharmacotherapy [44, 45].
The deep TMS has emerged as a promising treatment for TRD, demonstrating
signicant efcacy in various clinical studies. Another systematic review by Berlim
etal. [11, 46] highlighted that deep TMS can lead to substantial improvements in
depressive symptoms, particularly in patients who have not responded to conventional therapies [46]. The review synthesized data from multiple studies, indicating
that deep TMS is effective in reducing depression scores measured by validated
scales such as the HAMD and the Montgomery–Asberg Depression Rating Scale
(MADRS).
In an RCT conducted by Holtzheimer etal. [47], patients undergoing deep TMS
showed notable reductions in depressive symptoms compared to those receiving
sham treatment. The study reported that a signicant percentage of participants
experienced a 50% or greater improvement in their MADRS scores after several
weeks of deep TMS therapy. This nding underscores the potential of deep TMS as
an effective intervention for individuals with chronic depression [47].
Additional research by Fitzgerald and Segrave [48] emphasized the durable
effects of deep TMS, with many patients maintaining improvements in depressive
symptoms well after the treatment period. Long-term follow-up studies showed that
the benets of deep TMS could persist, making it a viable option for ongoing management of TRD [48].
A recent study [49] aimed to evaluate the efcacy of deep TMS in patients who
did not respond to the initial acute treatment phase. In this RCT, 33 medication-free
participants who completed 20 sessions of deep TMS over 4weeks were identied
as nonresponders. Following this, they continued with active deep TMS treatment
twice weekly for up to 12 additional weeks. The ndings were promising: 72.7% of
nonresponders eventually achieved responder status during the continuation phase,
with 60.6% responding within the rst 4weeks of extended treatment. Notably,
63.6% of participants reached remission at some point during the study. These
results suggest that continuing deep TMS treatment beyond the initial acute course
may signicantly benet patients who initially do not respond, offering hope for
long-term symptom relief in those with TRD.
An RCT [50] explored the efcacy and safety of accelerated deep TMS protocols
using the H1-coil in patients with TRD.A total of 28 participants underwent accelerated deep TMS sessions lasting 20min, delivered twice daily for either 10 or
15days. The primary outcomes assessed included changes in HAMD scores and
any discontinuation of treatment due to adverse events. Results showed signicant
reductions in HAMD scores, with decreases of 13 points (59% improvement) for
the 10-day protocol and 13 points (62% improvement) for the 15-day protocol,
indicating substantial clinical benet. Remission rates were also notable, with 38%
achieving remission after the 10-day protocol and 42% after the 15-day protocol.
Additionally, signicant and clinically relevant reductions in Beck Depression
Inventory-II scores were observed, particularly during the rst week. These promising ndings suggest that twice-daily accelerated deep TMS may be a safe and
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T. Zhang et al.
effective intervention for TRD, highlighting the need for further research through
larger RCTs to compare accelerated deep TMS with standard deep TMS protocols.
Finally, the practical applications of deep TMS in clinical practice have been
supported by its positive outcomes in real-world settings. Studies conducted in outpatient clinics have consistently reported high rates of response and remission
among patients receiving deep TMS, reinforcing its role as an effective treatment
modality for those suffering from depression that does not adequately respond to
traditional therapies [51].
3.2.2.2 Safety
The deep TMS is generally considered a safe intervention, characterized by a prole
of adverse effects that are mostly mild and manageable. The systematic review of
clinical trials highlights that the most frequently reported adverse effects include
headaches and localized pain or discomfort at the stimulation site. These effects are
typically transient and resolve shortly after treatment, making them relatively easy
to address.
While serious adverse events are rare, they have been documented, including
instances of seizures and suicidal ideation or attempts. Such occurrences underscore
the importance of careful screening and monitoring of patients undergoing deep
TMS, as the potential for serious adverse effects, although low, necessitates vigilance in clinical practice.
The review also assessed the risk of bias across studies, nding a collectively low
risk according to the Grading of Recommendations, Assessment, Development, and
Evaluations checklist. This suggests that the reported safety outcomes are reliable
and support the overall safety prole of deep TMS as an intervention.
Available literature indicates that deep TMS can serve as a safe alternative or
adjunctive treatment for individuals who do not respond adequately to traditional
therapies. Its safety prole particularly supports its use in treating conditions such
as MDD, obsessive–compulsive disorder, and substance use disorders, where treatment-resistant patients may benet the most.
Looking ahead, ongoing research is necessary to further understand the longterm safety and potential adverse effects of deep TMS, especially in diverse patient
populations. This continued investigation will help to ensure that deep TMS remains
a viable option in the therapeutic landscape for psychiatric and cognitive disorders.
3.2.2.3 Treatment Regimen
The deep TMS employs specialized H-coils, which are designed to stimulate deeper
brain regions compared to traditional TMS coils. These coils can reach brain areas
approximately 4cm beneath the scalp, enabling more effective treatment for various
psychiatric and cognitive disorders.
The treatment typically involves HF stimulation, usually at 18–20Hz, delivered
at an intensity of 120% of the resting motor threshold (MT). Each session lasts
about 20–40min, and the regimen often consists of daily treatments over a period
of 2–4weeks, tailored to the specic disorder and individual response.
3 TMS and tDCS for Major Depressive Disorder
45
Depending on the condition being treated, different H-coil designs may target
various brain structures. For example, the prefrontal cortex is often targeted for
depression, while the anterior cingulate cortex may be targeted for anxiety disorders. This specicity helps maximize treatment efcacy.
Throughout the treatment, patients are closely monitored to assess tolerability
and effectiveness. Common adverse effects include mild headaches and discomfort
at the site of stimulation, which are usually manageable.
After completing the treatment regimen, patients undergo evaluations to measure
changes in symptoms and overall functioning. Follow-up sessions may be scheduled to help maintain the benets of the treatment, particularly for those who have
not responded well to traditional therapies.
3.2.2.4 Clinical Recommendations
The deep TMS has demonstrated signicant efcacy in treating MDD, particularly
in patients who are TRD or have not responded adequately to traditional pharmacological therapies. Clinical trials indicate that deep TMS can lead to marked improvements in depressive symptoms, making it a viable alternative or adjunct treatment
option. Clinicians should consider deep TMS for patients with a conrmed diagnosis of MDD who exhibit persistent symptoms despite prior treatments.
The recommended treatment regimen for deep TMS in MDD typically
involves HF stimulation (18–20Hz) delivered at an intensity of 120% of the
resting MT over a series of daily sessions lasting 20–40min, often conducted
over 2–4weeks. Continuous monitoring of patient responses and adverse effects
is crucial, as mild headaches and discomfort at the stimulation site are common.
Regular follow-up assessments should be conducted to evaluate treatment efcacy and make necessary adjustments to the regimen, ensuring optimal outcomes for patients.
Based on two high-quality studies [45, 52], therefore, level A evidence (denite
efcacy) is recommended for deep HF-rTMS of the left DLPFC in patients with
MDD, including the elderly [22].
3.2.3 Priming rTMS
3.2.3.1 Efficacy
In Fitzgerald et al.’s study of 60 MDDs (30 real, 30 sham), the priming group
showed a signicantly greater reduction in depression scores on the MADRS than
the sham group [53]. In another study comparing a priming LF rTMS protocol to a
bilateral rTMS protocol in a large series of 179 patients, a signicant mean reduction of >50% in HDRS-17 score (with a response rate of 56% and a remission rate
of 40%) was found in both treatment groups, but no difference between groups at
the end of the 4-week protocol [31]. Priming rTMS can also produce similar antidepressant effects in late-life depression [54].
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T. Zhang et al.
3.2.3.2 Safety
Priming rTMS is well tolerated for the treatment of depressed adults and the elderly.
No major adverse events have been reported with priming rTMS.Common adverse
events included scalp discomfort, lacrimation, malaise, headache, and nausea. All of
these adverse effects were mild in intensity, resolved within 1h of completion of
treatment, and did not require medical intervention.
3.2.3.3 Treatment Regimen
Twenty trains of 5s duration at 6Hz and 90% of the resting MT followed by 1Hz
stimulation (110% of MT, one continuous train of 900 pulses). Each treatment was
administered for up to 4weeks, 5days per week (total of 20 treatment sessions) for
adult MDDs [31] and 6Hz rTMS over the right DLPFC at 80% resting MT for
10min (600 stimulations; 20 trains of 5s each) followed by 1Hz rTMS over the
right DLPFC at 100% resting MT for 21min (1200 stimulations; 60 pulses per train,
with 20 trains, and a 5s intertrain interval), total of 10 daily sessions, for 2weeks
for late-life depression.
3.2.3.4 Clinical Recommendations
Although evidence supports a similar efcacy of priming rTMS protocols and bilateral rTMS protocols [31] and in favor of sham stimulation [54], it is premature to
recommend the use of accelerated rTMS protocols for the treatment of MDD.
3.2.4 Synchronized rTMS
3.2.4.1 Efficacy
Synchronizing a TMS pulse with a person’s underlying EEG rhythm can modify the
brain’s response. Compared with unsynchronized rTMS, patients with MDD who
received synchronized rTMS showed no difference in overall clinical response [55].
No signicant difference was found between xed and randomly synchronized
rTMS groups [56]. Either xed or random frequency active synchronized rTMS had
a statistically signicantly greater percentage reduction in depression severity compared to sham [56]. However, two other studies found no difference in efcacy
between active and sham synchronized rTMS [57, 58].
3.2.4.2 Safety
Synchronized rTMS is well tolerated for the treatment of MDD.No major adverse
events have been reported with synchronized rTMS. Common adverse events
included headache, dizziness, visual disturbance, dyschezia, back pain, insomnia,
and respiratory tract infection. Common adverse effects resolved shortly after
treatment.
3.2.4.3 Treatment Regimen
According to the study by George etal. [55], for each rTMS session, subjects had
EEG setups, received synchronized rTMS, and received the following dose of rTMS
3 TMS and tDCS for Major Depressive Disorder
47
delivered over the left prefrontal cortex: 6–13Hz (at individual alpha frequency),
120% MT, 40 pulses per train, average 4-s pulse train, 3000 pulses per session, one
session per weekday, as the train length varied by frequency (e.g., it takes 4s at
10Hz to get 40 pulses, but 5s at 8Hz). The intertrain off time (8–12s) was adjusted
so that all treatment sessions were the same length regardless of individual alpha
frequency. Treatments were administered for a xed interval of 6weeks. Interruptions
during treatment were allowed as needed for patient comfort or convenience using
the “pause” selection on the device. For xed frequency synchronized rTMS, set to
the subject’s average individual alpha frequency±0.1 Hz; for random frequency
synchronized rTMS, with a random stimulus frequency that varied between 8 and
13Hz [56].
3.2.4.4 Clinical Recommendations
Synchronized rTMS may be an effective treatment for MDD.It is premature to
recommend the use of synchronized rTMS protocols for the treatment of MDD.
3.2.5 TBS
3.2.5.1 iTBS
Efficacy
TBS represents an innovative advancement in TMS techniques, tailored for the
treatment of MDD [13]. The rationale for employing TBS lies in its unique stimulation pattern, which delivers bursts of HF pulses (50Hz) at intervals designed to
replicate theta rhythms found in the brain. This approach has been shown to enhance
synaptic plasticity—an essential mechanism for learning and memory—thereby
potentially addressing the neurobiological decits present in depression.
One of the key mechanisms by which TBS may exert its effects is through the
modulation of cortical excitability. Animal studies [59] have highlighted TBS’s
ability to induce both long-term potentiation and long-term depression in neuronal
circuits [60]. These processes are crucial for the adaptive functioning of neural networks, particularly in areas like the DLPFC, which is often implicated in mood
regulation. By affecting these pathways, TBS can alter the excitability and connectivity of brain regions associated with depressive symptoms.
Additionally, TBS’s design allows for a more efcient application compared to
rTMS.With treatment durations of only 1–3min, TBS is not only time-efcient but
also reduces the burden on patients and clinicians. This efciency is particularly
important in clinical settings where patient throughput and comfort are critical considerations. The reduced intensity required for TBS (typically around 80% of the
active MT) further ensures that the method is both safe and tolerable, minimizing
the risk of adverse effects that can accompany longer or more intense stimulation
protocols [61].
Finally, the application of TBS in MDD aligns with emerging insights into the
neurobiological basis of depression, particularly the interhemispheric asymmetry
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T. Zhang et al.
observed in the DLPFC.By utilizing intermittent TBS on the left DLPFC and continuous TBS on the right, this technique aims to restore balance between these
hemispheres, addressing the dysregulation often seen in depressed individuals. This
targeted approach not only supports the theoretical underpinnings of TBS but also
reects a growing understanding of the need for personalized and precise treatment
modalities in psychiatry.
In summary, the rationale for TBS–TMS in MDD is grounded in its ability to
leverage principles of synaptic plasticity, enhance cortical excitability, and provide
a more efcient, patient-friendly treatment option that addresses the specic neurobiological features of MDD.
In the context of the efcacy of TBS, several studies have demonstrated its signicant effectiveness in treating MDD.An important study [62] designed as an
RCT conducted at three Canadian university hospitals, involving participants aged
18–65 with TRD.Eligible individuals had to show a current episode of MDD with
an HAMD-17 score of at least 18 and a history of insufcient response to at least
two antidepressant treatments. Participants were randomly assigned to receive
either HF rTMS at 10Hz or iTBS, with both treatments administered ve times a
week over 4–6weeks.
Results indicated that both treatment groups experienced signicant reductions
in HAMD-17 scores, with the 10Hz rTMS group improving from a baseline score
of 23.5–13.4, and the iTBS group from 23.6 to 13.4. The estimated adjusted difference in scores favored iTBS, conrming its non-inferiority to 10Hz rTMS, with a
p-value of 0.0011. This nding suggests that iTBS can achieve similar clinical outcomes in a much shorter treatment time, enhancing the feasibility of rTMS therapy.
Regarding adverse effects, both treatments exhibited comparable tolerability,
although the self-reported pain level was slightly higher in the iTBS group. The
dropout rates were similar, with 6% in the 10 Hz rTMS group and 8% in the iTBS
group, and headaches were the most commonly reported adverse effect. Overall, the
study concluded that iTBS is an effective alternative to traditional rTMS, potentially
increasing treatment capacity for depression without sacricing effectiveness or
safety. This RCT highlighted that patients receiving TBS exhibited a marked reduction in depressive symptoms, with many reporting substantial improvements within
just a few sessions. Follow-up assessments indicated that these positive outcomes
were maintained for several months after treatment, suggesting that TBS not only
provides immediate relief but also long-lasting benets.
Overall, the accumulating evidence supports the efcacy of TBS as a promising
therapeutic option in mental health care. As more clinical trials are conducted, the
potential for TBS to become a widely accepted treatment modality in psychiatric
practice becomes increasingly evident. The combination of rapid symptom relief
and minimal adverse effects positions TBS as a vital tool for improving patient
outcomes in depression management.
The Stanford Neuromodulation Therapy (SNT) protocol represents the most
accelerated theta burst stimulation (aTBS) approach for MDD to date [63–65].
This innovative method delivers a total of 90,000 pulses of iTBS over 5 days,
equating to ve times the standard dose typically administered in a conventional