Obsessive-Compulsive DisorderNCT05104697
TMS for Improving Response Inhibition in Adolescents With OCD
A study testing Transcranial Magnetic Stimulation in people with Obsessive-Compulsive Disorder, run by Bradley Hospital at 1 site in United States.
Trial summary
The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits, improves response inhibition, and reduces compulsions in adolescents with OCD. Read more about this study
- Who is it for?
- Ages 13 to 18 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?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Sep 2023
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-18 years
- Presence of OCD, as indicated by score on the Children's Yale-Brown Obsessive-Compulsive Scale
- Patient and one parent speak English fluently (to ensure comprehension of study measures and instructions
- Right-handed
- If taking psychotropic medications, these have been stable for > 6 weeks and are expected to remain stable for the approximately 3-week study protocol
- If currently in psychotherapy, symptom improvement has plateaued (no improvement in the past 6 weeks and symptoms expected to remain stable for the approximately 3-week study protocol)
Who cannot join
- • Medical conditions contraindicated for TMS or EEG, including history of intracranial pathology, increased intracranial pressure, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, possible pregnancy (female of childbearing age not using effective contraception), or any other serious medical condition (note that medical history will be reviewed by a study physician prior to TMS administration)
- Metal in the head, except mouth (e.g., cochlear implant, implanted brain stimulators, aneurysm clips)
- Active suicidality or psychosis
- Existing diagnosis of Bipolar disorder, Autism Spectrum Disorder, mental retardation, or cognitive disability
- Substance abuse or dependence
- Taking a stimulant medication (and unwilling to forgo on study visit days)
Show all 10Show fewer
- Taking medication with the potential to lower seizure threshold (e.g., neuroleptics, antipsychotics)
- Patient is a ward of the state
- Family history of epilepsy
- History of syncope
Trial locations and contacts
1 site in 1 country.
United States1 site
Emma Pendleton Bradley Hospital
Riverside, Rhode Island, 02915
About this study
The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits, improves response inhibition, and reduces compulsions in adolescents with OCD.
- 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
All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
| Study group | Role | What they receive |
|---|---|---|
| TMS at visit 1, Sham at visit 2 | Other | At visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location. Receives: Device: Transcranial Magnetic Stimulation |
| Sham at visit 1, TMS at visit 2 | Other | At visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Response Time on Stop Trials of the Stop Signal Task
Computerized task, where shorter response time (in milliseconds) indicates better performance
Measured: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG)
Electroencephalogram (EEG) measured amplitude on successful stop trials of the stop signal task (SST). Calculated by averaging the epochs of successful stop trials time-locked to the stop signal from the midline electrode (Cz).
Measured: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Secondary outcomes (1)
Self-report Symptom Question
Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions
Measured: post (within 1 hour after) intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Apr 2022
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
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.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Butler Hospital, University of Minnesota
- Responsible party
- Principal investigator, Kristen Benito, Bradley Hospital
- Investigators
- Kristen Benito, PhD, Principal investigator, Bradley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104697
- Sponsor's protocol ID
- 1697181
- Other IDs
- 5P20GM130452
- Status last verified
- Jan 2025
- First submitted
- 9 Oct 2021
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS for Improving Response Inhibition in Adolescents With OCD
- ClinicalTrials.gov ID
- NCT05104697
- Acronym / sponsor ID
- 1697181
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Collaborators
- Butler Hospital, University of Minnesota
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits, improves response inhibition, and reduces compulsions in adolescents with OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol
| Arm | Type | Receives |
|---|---|---|
| TMS at visit 1, Sham at visit 2 | Other | Device: Transcranial Magnetic StimulationAt visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location. |
| Sham at visit 1, TMS at visit 2 | Other | Device: Transcranial Magnetic StimulationAt visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 13-18 years
- Presence of OCD, as indicated by score on the Children's Yale-Brown Obsessive-Compulsive Scale
- Patient and one parent speak English fluently (to ensure comprehension of study measures and instructions
- Right-handed
- If taking psychotropic medications, these have been stable for > 6 weeks and are expected to remain stable for the approximately 3-week study protocol
Key exclusion criteria (10 listed)
- • Medical conditions contraindicated for TMS or EEG, including history of intracranial pathology, increased intracranial pressure, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, possible pregnancy (female of childbearing age not using effective contraception), or any other serious medical condition (note that medical history will be reviewed by a study physician prior to TMS administration)
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 StimulationAll teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced) | Device | Sham at visit 1, TMS at visit 2, TMS at visit 1, Sham at visit 2 |
Primary outcome
Change in Response Time on Stop Trials of the Stop Signal Task
Time frame: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Computerized task, where shorter response time (in milliseconds) indicates better performance
Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG)
Time frame: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Electroencephalogram (EEG) measured amplitude on successful stop trials of the stop signal task (SST). Calculated by averaging the epochs of successful stop trials time-locked to the stop signal from the midline electrode (Cz).
1 secondary outcome
Self-report Symptom Question
Time frame: post (within 1 hour after) intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kristen Benito, PhD principal investigator
Bradley 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 Bradley 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 6 inclusion and 10 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 28 Jan 2025. 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. 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 28 Jan 2025). 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?
Change in Response Time on Stop Trials of the Stop Signal Task (time frame: Change from pre (within 1 hour before) to post (within 1 hour after) intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2025.