Obsessive Compulsive DisorderTMSOCDNCT02355002
Transcranial Magnetic Stimulation (TMS) in Obsessive Compulsive Disorder (OCD): Mechanisms and Biomarkers
A study testing Transcranial Magnetic Stimulation in people with Obsessive Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive compulsive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 18-65 years of age.
- Proficient in English.
- A diagnosis of primary OCD (as determined by SCID).
- Yale-Brown Obsessive Compulsive Scale total score ≥ 16.
- Normal (or corrected) vision.
- Stable medication regimen or medication free for ≥ 12 weeks prior to study; benzodiazepine free ≥ 2 weeks.
- Right-handed (Edinburgh Handedness Inventory - Short Form total score ≥ 61)
- Able to give informed consent.
Who cannot join
- Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in TMS
- Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
- Substance abuse or dependence that is current or within the last six months or use of an illicit drug that is not prescribed, as indicated by a urine drug screen and/or clinical inference.
- Use of benzodiazepines or anticonvulsants within 2 weeks prior to study (to be ruled out by a urine drug screen).
- Use of Tricyclic Antidepressants (e.g. Clomipramine).
- Use of other psychotropic medications (e.g., SSRIs) will be allowed provided the dose has been stable for > 12 weeks.
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- Documented resistance to 4 or more valid pharmacological trials of 2 or more different medication classes (e.g. SSRIs and TCAs).
- Previous exposure to TMS.
- Major/chronic medical conditions.
- History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae.
- Prior neurosurgical procedure.
- Metal in the body, metal injury to the eyes.
- History of seizures.
- Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
- Pregnancy; breastfeeding or nursing; for women of childbearing a pregnancy test (to be ruled out by urine β-HCG) will be conducted prior to study.
- Currently in Cognitive Behavioral Therapy (CBT).
- Diagnosis of primary sleep disorder such as primary insomnia, narcolepsy, sleep apnea, shift work sleep disorder and others. Sleep disorders such as insomnia or hypersomnia that are secondary to depression or OCD are permitted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive compulsive disorder. Additionally, this study aims to identify the mechanisms of action of TMS and potential biomarkers and predictors of treatment response.
Read the detailed description
This treatment study examines the use of transcranial magnetic stimulation (TMS) in treating people with OCD and investigates what areas of the brain are involved during emotional learning. TMS is a noninvasive method in which a magnetic "coil" is placed near an individual's head and delivers small magnetic pulses into the brain, which produce small electrical currents in the brain, stimulating brain cells that may relieve OCD symptoms. TMS has been FDA approved since 2008 and Health Canada approved since 2002 as a treatment for depression. Our hope is to demonstrate that TMS is a successful treatment option for individuals struggling with OCD symptoms, and to identify the specific areas of the brain that are targeted through TMS.
Patients will be randomized (like the flip of a coin) to one of two groups: 6 weeks of daily active TMS, or 6 weeks of daily placebo (sham) TMS sessions. During phase I, participation in this study will last about 8 weeks and patients will be asked to make about 36 visits to our clinics at the MGH main campus and the MGH Charlestown Navy Yard campus. Patients will also participate in MRI scanning sessions and clinical assessments.
If patients' symptoms do not improve after phase I, they will be invited to participate in phase II. During phase II, patients receive 30 active TMS sessions over 6 weeks, as well as MRI scans and clinical assessments.
Part of the MRI scanning sessions will include participating in a task that uses mild, half-second electric shocks to fingers. The electric current will be generated from a 9V battery (e.g., battery in a smoke alarm), and is much less annoying than a static shock. In order to set the level of the current to be used during the study, we will begin at a level below what patients will be able to feel, and then increase in gradual steps with permission. Patients will be asked to stop the increase at a level of the current that they find highly annoying but not painful. The level of current that patients select during this trial procedure, and no higher level, will be used during the study so that they will not receive any painful electric shocks. The purpose of the electric shock is to create a situation in which emotional learning may occur. Patients will receive no more than ten of these electric shocks.
Compensation is provided for clinical assessments and MRI scan sessions.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.
| Study group | Role | What they receive |
|---|---|---|
| Active Transcranial Magnetic Stimulation (TMS) treatment | Experimental | In this arm subjects will receive real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. Receives: Device: Transcranial Magnetic Stimulation |
| Sham-TMS treatment | Sham comparator | This arm serves as the sham/placebo control. In TMS a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive Compulsive Symptoms as Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the gold-standard, semi-structured clinician-administered assessment of OCD symptom severity. It contains 10 items ranging from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. Higher scores indicate more severe OCD symptom severity. We compared the efficacy of TMS to Sham in reducing OCD symptom severity over a 6-week period. Efficacy was again compared in the follow-up phase of the study in from week 6 to week 18.
Measured: Change in YBOCS from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.
Secondary outcomes (2)
Obsessive Compulsive Beliefs as Measured by Obsessive-Compulsive Beliefs Questionnaire (OBQ)
The Obsessive-Compulsive Beliefs Questionnaire (OBQ) is a patient-rated assessment of beliefs considered important in the development and maintenance of obsessive-compulsive disorder (OCD). It contains 44 items ranging from 1 (disagree very much) to 7 (agree very much) across 3-4 thought domains, yielding a total possible score range from 44 to 308. Higher scores indicate more strongly held OCD-related beliefs. We compared the efficacy of TMS to Sham in reducing OCD beliefs over a 6-week period. Efficacy was again compared in the follow-up phase of the study in from week 6 to week 18.
Measured: Change in OBQ from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.
Total Number of Obsessive Symptoms is Reduced as Measured by Obsessive-Compulsive Inventory Questionnaire (OCI)-Revised
The Obsessive Compulsive Inventory-Revised (OCI-R) is a self-report questionnaire that measures OCD symptoms across 6 sub-scales including washing, checking, neutralizing, obsessing, ordering and hoarding. It contains 18 items ranging from 0 (not at all) to 4 (extremely), yielding a total possible score range from 0 to 72. Higher scores indicate more severe OCD symptoms. We compared the efficacy of TMS to Sham in reducing inventory of obsessive symptoms over a 6-week period. Efficacy was again compared in the follow-up phase of the study in from week 6 to week 18.
Measured: Change in OCI from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startMay 2015
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
- Investigators
- Joan A Camprodon, MD, MPH, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355002
- Sponsor's protocol ID
- 2014P002560
- Acronym
- TMSOCD
- Status last verified
- May 2023
- First submitted
- 30 Jan 2015
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
PubMed 19833552
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (TMS) in Obsessive Compulsive Disorder (OCD): Mechanisms and Biomarkers
- ClinicalTrials.gov ID
- NCT02355002
- Acronym / sponsor ID
- TMSOCD / 2014P002560
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Posted 8 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive compulsive disorder. Additionally, this study aims to identify the mechanisms of action of TMS and potential biomarkers and predictors of treatment response.
Detailed description
This treatment study examines the use of transcranial magnetic stimulation (TMS) in treating people with OCD and investigates what areas of the brain are involved during emotional learning. TMS is a noninvasive method in which a magnetic "coil" is placed near an individual's head and delivers small magnetic pulses into the brain, which produce small electrical currents in the brain, stimulating brain cells that may relieve OCD symptoms. TMS has been FDA approved since 2008 and Health Canada approved since 2002 as a treatment for depression. Our hope is to demonstrate that TMS is a successful treatment option for individuals struggling with OCD symptoms, and to identify the specific areas of the brain that are targeted through TMS.
Patients will be randomized (like the flip of a coin) to one of two groups: 6 weeks of daily active TMS, or 6 weeks of daily placebo (sham) TMS sessions. During phase I, participation in this study will last about 8 weeks and patients will be asked to make about 36 visits to our clinics at the MGH main campus and the MGH Charlestown Navy Yard campus. Patients will also participate in MRI scanning sessions and clinical assessments.
If patients' symptoms do not improve after phase I, they will be invited to participate in phase II. During phase II, patients receive 30 active TMS sessions over 6 weeks, as well as MRI scans and clinical assessments.
Part of the MRI scanning sessions will include participating in a task that uses mild, half-second electric shocks to fingers. The electric current will be generated from a 9V battery (e.g., battery in a smoke alarm), and is much less annoying than a static shock. In order to set the level of the current to be used during the study, we will begin at a level below what patients will be able to feel, and then increase in gradual steps with permission. Patients will be asked to stop the increase at a level of the current that they find highly annoying but not painful. The level of current that patients select during this trial procedure, and no higher level, will be used during the study so that they will not receive any painful electric shocks. The purpose of the electric shock is to create a situation in which emotional learning may occur. Patients will receive no more than ten of these electric shocks.
Compensation is provided for clinical assessments and MRI scan sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Transcranial Magnetic Stimulation (TMS) treatment | Experimental | Device: Transcranial Magnetic StimulationIn this arm subjects will receive real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil. |
| Sham-TMS treatment | Sham comparator | Device: Transcranial Magnetic StimulationThis arm serves as the sham/placebo control. In TMS a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-65 years of age.
- Proficient in English.
- A diagnosis of primary OCD (as determined by SCID).
- Yale-Brown Obsessive Compulsive Scale total score ≥ 16.
- Normal (or corrected) vision.
Key exclusion criteria (17 listed)
- Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in TMS
- Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
- Substance abuse or dependence that is current or within the last six months or use of an illicit drug that is not prescribed, as indicated by a urine drug screen and/or clinical inference.
- Use of benzodiazepines or anticonvulsants within 2 weeks prior to study (to be ruled out by a urine drug screen).
- Use of Tricyclic Antidepressants (e.g. Clomipramine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationTranscranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. | Device | Active Transcranial Magnetic Stimulation (TMS) treatment, Sham-TMS treatment |
Primary outcome
Obsessive Compulsive Symptoms as Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: Change in YBOCS from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the gold-standard, semi-structured clinician-administered assessment of OCD symptom severity. It contains 10 items ranging from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. Higher scores indicate more severe OCD symptom severity. We compared the efficacy of TMS to Sham in reducing OCD symptom severity over a 6-week period. Efficacy was again compared in the follow-up phase of the study in from week 6 to week 18.
2 secondary outcomes
Obsessive Compulsive Beliefs as Measured by Obsessive-Compulsive Beliefs Questionnaire (OBQ)
Time frame: Change in OBQ from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.
Total Number of Obsessive Symptoms is Reduced as Measured by Obsessive-Compulsive Inventory Questionnaire (OCI)-Revised
Time frame: Change in OCI from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19833552Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan A Camprodon, MD, MPH, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Obsessive Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Feb 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive Compulsive Symptoms as Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: Change in YBOCS from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.). 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 NCT02355002, which also lists 1 linked publication.
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 13 Feb 2026.