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Major Depressive DisorderNCT07775586

Home-Based Wearable rTMS Therapy for Moderate to Severe Depression

A study testing rTMS-Tiny Treatment in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Background and Rationale With rapid economic development and increasing societal pressures, the incidence of neuropsychiatric disorders has risen annually, ranking as the leading cause of disability worldwide and imposing a severe societal burden. Among these, depressive disorders represent a primary contributor. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
rTMS-Tiny Treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
1 siteChina
Study dates
20 Aug 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion Criteria
  2. Demographics Aged 18-65 years, any gender. Minimum education: primary school completion (≥6 years of formal education).
  3. Diagnostic and Severity Requirements Meet DSM-5 criteria for Major Depressive Disorder (MDD). Current moderate-to-severe depressive episode, defined by Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥18 .
  4. Pharmacological Stability Stable antidepressant regimen for ≥4 weeks prior to enrollment, restricted to SSRIs (Selective Serotonin Reuptake Inhibitors). Treatment-naïve patients permitted if no psychotropic medications used within the prior 4 weeks. Mandatory maintenance of the same regimen throughout the study and post-treatment follow-up.
  5. Technical Feasibility Medically eligible for both structural MRI and resting-state functional MRI (fMRI) examinations.
  6. Exclusion Criteria
  7. Psychiatric Comorbidities Any concurrent psychiatric diagnosis (e.g., autism spectrum disorder, severe cognitive impairment, epilepsy, mania, psychosis) .
  8. Neurological Structural Abnormalities Structural brain lesions increasing seizure risk or disrupting neural connectivity (e.g., brain tumors, history of stroke).
  9. Systemic Medical Conditions Unstable cardiovascular, respiratory, hepatic, renal diseases, or active malignancies.
  10. Contraindications to Procedures TMS contraindications: Metallic implants, pacemakers, history of epilepsy. MRI contraindications: Ferromagnetic implants, claustrophobia requiring sedation.
  11. Recent Neuromodulation Therapies Prior ECT (Electroconvulsive Therapy) or rTMS (repetitive Transcranial Magnetic Stimulation) within 3 months.

History of neurosurgical interventions for depression (e.g., deep brain stimulation).

6）Special Populations Pregnancy, lactation, or planning pregnancy during the study. 7）Medication Instability Planned adjustments to pharmacotherapy during the study period. 3. Withdrawal and Discontinuation Criteria

  1. Participant-Initiated Withdrawal Voluntary withdrawal: Participant withdraws consent (e.g., refusal to risk assignment to sham stimulation group).
  2. Investigator-Initiated Withdrawal Non-compliance with inclusion criteria: Post-randomization discovery of ineligibility (e.g., symptom remission, medication non-adherence). Serious Adverse Events (SAEs): TMS-related SAEs (e.g., seizure, intractable headache, exacerbated suicidality).
  3. Study Discontinuation

Prespecified Efficacy Stoppage:

Interim analysis at n=30/group showing superiority of active intervention (Cohen's d >0.8) .

Safety-Driven Discontinuation:

Unacceptable risk profile (e.g., recurrent SAEs such as seizures or suicidality).

Loss to Follow-Up:

Trial termination if attrition rate exceeds pre-specified thresholds compromising statistical power (e.g., >20% dropout).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoyun Guo contact

86-13524600458

xiaoyunguo@163.com

China1 site

  • Shanghai Mental Health Center (SMHC)

    Shanghai

Other trials in China

About this study

Official title: Multicenter Randomized Controlled Trial Assessing Wearable Repetitive Transcranial Magnetic Stimulation for Home-Based Treatment of Depression

Background and Rationale

With rapid economic development and increasing societal pressures, the incidence of neuropsychiatric disorders has risen annually, ranking as the leading cause of disability worldwide and imposing a severe societal burden. Among these, depressive disorders represent a primary contributor. However, the efficacy and accessibility of transcranial magnetic stimulation (TMS) for depression face significant challenges. Key limitations include:

Read more

Low targeting accuracy with traditional localization methods. Limited clinical penetration of individualized precision paradigms .

In this context, wearable repetitive TMS (wrTMS) technology offers a transformative solution. The rTMS-Tiny device, developed by the Institute of Automation, Chinese Academy of Sciences, exemplifies this innovation with the following features:

Battery-powered with a pulse capacity exceeding 8,000 pulses per charge. Ultra-lightweight design: Total system weight <3 kg, coil helmet <2 kg (10% of conventional devices).

Performance parity: Comparable efficacy to standard rTMS systems while enabling protocols like Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) .

Advantages of rTMS-Tiny Portable Design and Wearable Application Ergonomically optimized helmet allows near-unrestricted daily activities during treatment .

Streamlined Operational Workflow Simplified protocols significantly reduce clinician workload . Enhanced Treatment Tolerability Improved comfort increases treatment completion rates and long-term adherence, directly enhancing therapeutic outcomes .

These advantages enable high-dose, intensive regimens (e.g., SAINT-like protocols) in routine clinical practice .

Scientific Imperative for a Multicenter RCT

A multicenter randomized controlled trial (RCT) of rTMS-Tiny is clinically and scientifically warranted to:

Test two core hypotheses:

Hypothesis 1: Efficacy of rTMS-Tiny in reducing depressive symptoms. Hypothesis 2: Safety of home-based rTMS-Tiny administration . Generate high-level evidence to advance neuromodulation into an era of precision, personalization, and artificial intelligence-driven therapy .

Being tested
rTMS-Tiny Treatment, Sham Stimulation
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMS-Tiny TreatmentDevice

    Stimulation protocol using the rTMS-Tiny device with identical parameters to SNT:

    Stimulation mode Intermittent Theta-Burst Stimulation (iTBS) Burst composition: Each burst consists of 3 pulses at 50 Hz Train structure: 10 bursts repeated at 5 Hz per train (total train duration: 2 seconds) Inter-train interval: 8 seconds Session parameters Pulses per session: 1,800 pulses Session duration: 570 seconds (≈9.5 minutes) Inter-session interval: 50 minutes Daily frequency: 10 sessions per day Weekly schedule: 5 days per week Treatment course: 1 week (total 50 sessions) Total pulses per course: 1,800 pulses/session × 50 sessions = 90,000 pulses

  • Sham StimulationDevice

    The key difference lies in the use of a sham stimulation coil instead of the rTMS-Tiny active treatment coil.

Study groups in NCT07775586
Study groupRoleWhat they receive
rTMS-Tiny Treatment GroupExperimentalStimulation protocol using the rTMS-Tiny device with identical parameters to SNT: Stimulation mode Intermittent Theta-Burst Stimulation (iTBS) Burst composition: Each burst consists of 3 pulses at 50 Hz Train structure: 10 bursts repeated at 5 Hz per train (total train duration: 2 seconds) Inter-train interval: 8 seconds Session parameters Pulses per session: 1,800 pulses Session duration: 570 seconds (≈9.5 minutes) Inter-session interval: 50 minutes Daily frequency: 10 sessions per day Weekly schedule: 5 days per week Treatment course: 1 week (total 50 sessions) Total pulses per course: 1,800 pulses/session × 50 sessions = 90,000 pulses
Receives: Device: rTMS-Tiny Treatment
rTMS-Tiny Sham Stimulation GroupPlacebo comparatorThe key difference lies in the use of a sham stimulation coil instead of the rTMS-Tiny active treatment coil.
Receives: Device: Sham Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score

    Depressive symptom severity was assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17; total score range, 0-52, with higher scores indicating more severe depression；Treatment Response Rate:≥50% reduction from baseline in HAMD-17 total score;Treatment Remission Rate:Post-treatment HAMD-17 Score < 8)

    Measured: T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)

Secondary outcomes (1)

  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    Depressive symptom severity assessed with the Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item clinician-rated scale. The total score ranges from 0 (minimum) to 60 (maximum); higher scores indicate more severe depressive symptoms (worse outcome), and lower scores indicate improvement.

    Measured: T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2026
  2. Study start20 Aug 2026 (estimated)
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07775586
Sponsor's protocol ID
SMHCGXY-3
Status last verified
Aug 2026
First submitted
13 Jul 2025
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weigand A, Horn A, Caballero R, Cooke D, Stern AP, Taylor SF, Press D, Pascual-Leone A, Fox MD. Prospective Validation That Subgenual Connectivity Predicts Antidepressant Efficacy of Transcranial Magnetic Stimulation Sites. Biol Psychiatry. 2018 Jul 1;84(1):28-37. doi: 10.1016/j.biopsych.2017.10.028. Epub 2017 Nov 10.

    PubMed 29274805

  • Voineskos D, Blumberger DM, Zomorrodi R, Rogasch NC, Farzan F, Foussias G, Rajji TK, Daskalakis ZJ. Altered Transcranial Magnetic Stimulation-Electroencephalographic Markers of Inhibition and Excitation in the Dorsolateral Prefrontal Cortex in Major Depressive Disorder. Biol Psychiatry. 2019 Mar 15;85(6):477-486. doi: 10.1016/j.biopsych.2018.09.032. Epub 2018 Oct 18.

    PubMed 30503506

  • Singh A, Erwin-Grabner T, Sutcliffe G, Antal A, Paulus W, Goya-Maldonado R. Personalized repetitive transcranial magnetic stimulation temporarily alters default mode network in healthy subjects. Sci Rep. 2019 Apr 4;9(1):5631. doi: 10.1038/s41598-019-42067-3.

    PubMed 30948765

  • Siddiqi SH, Trapp NT, Hacker CD, Laumann TO, Kandala S, Hong X, Trillo L, Shahim P, Leuthardt EC, Carter AR, Brody DL. Repetitive Transcranial Magnetic Stimulation with Resting-State Network Targeting for Treatment-Resistant Depression in Traumatic Brain Injury: A Randomized, Controlled, Double-Blinded Pilot Study. J Neurotrauma. 2019 Apr 15;36(8):1361-1374. doi: 10.1089/neu.2018.5889. Epub 2019 Jan 7.

    PubMed 30381997

  • Lisanby SH. Noninvasive Brain Stimulation for Depression - The Devil Is in the Dosing. N Engl J Med. 2017 Jun 29;376(26):2593-2594. doi: 10.1056/NEJMe1702492. No abstract available.

    PubMed 28657865

  • George MS. Whither TMS: A One-Trick Pony or the Beginning of a Neuroscientific Revolution? Am J Psychiatry. 2019 Nov 1;176(11):904-910. doi: 10.1176/appi.ajp.2019.19090957.

    PubMed 31672044

  • Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.

    PubMed 32252538

  • Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29.

    PubMed 34711062

  • Cash RFH, Weigand A, Zalesky A, Siddiqi SH, Downar J, Fitzgerald PB, Fox MD. Using Brain Imaging to Improve Spatial Targeting of Transcranial Magnetic Stimulation for Depression. Biol Psychiatry. 2021 Nov 15;90(10):689-700. doi: 10.1016/j.biopsych.2020.05.033. Epub 2020 Jun 7.

    PubMed 32800379

  • Brunoni AR, Chaimani A, Moffa AH, Razza LB, Gattaz WF, Daskalakis ZJ, Carvalho AF. Repetitive Transcranial Magnetic Stimulation for the Acute Treatment of Major Depressive Episodes: A Systematic Review With Network Meta-analysis. JAMA Psychiatry. 2017 Feb 1;74(2):143-152. doi: 10.1001/jamapsychiatry.2016.3644.

    PubMed 28030740

  • Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. doi: 10.1016/s0140-6736(85)92413-4. No abstract available.

    PubMed 2860322

  • Cash RFH, Zalesky A, Thomson RH, Tian Y, Cocchi L, Fitzgerald PB. Subgenual Functional Connectivity Predicts Antidepressant Treatment Response to Transcranial Magnetic Stimulation: Independent Validation and Evaluation of Personalization. Biol Psychiatry. 2019 Jul 15;86(2):e5-e7. doi: 10.1016/j.biopsych.2018.12.002. Epub 2019 Jan 19. No abstract available.

    PubMed 30670304

Questions about this trial

What is this clinical trial studying?

A study testing rTMS-Tiny Treatment in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoyun Guo (86-13524600458, xiaoyunguo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score (time frame: T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07775586, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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