Obsessive-Compulsive DisorderPhase 3NCT02704117
Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation
A Phase 3 study testing Transcranial Magentic Stimulation in people with Obsessive-Compulsive Disorder, run by Butler Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Transcranial Magentic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current primary OCD diagnosis and current Y-BOCS total score of ≥16
- 18-70 years of age
- Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
- No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry
- Ongoing psychotherapy allowed if already established for three months or more before study entry
Who cannot join
- History of primary psychotic disorder or bipolar disorder
- Present acute suicidality
- History of head injury, epilepsy, or other clinically significant neurological illness except tic disorders
- Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease
- Premorbid intelligence quotient (IQ) estimate < 80
- Visual disturbance (<20/40 Snellen visual acuity, corrected)
Show all 13Show fewer
- Current, or alcohol or illicit substance abuse/dependence in the last 3 months
- Contraindications to TMS or MRI: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia
- Women who are pregnant or breastfeeding. All women participants of reproductive age are required to have a negative pregnancy test prior to enrollment and use medically acceptable birth control throughout the study (barrier and/or oral contraceptives)
- Current psychotic symptoms
- An increased risk of seizure, determined by history
- Medications judged to notably affect cortical excitability e.g., anticonvulsants or high-dose benzodiazepines (> 4 mg/day of clonazepam or equivalent)
- Predominant hoarding symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurocircuitry of OCD: Effects Of Modulation
The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain stimulation might change the functioning of regions implicated in OCD, and thereby inform possible future therapeutic uses.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Transcranial Magentic 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 Magentic StimulationDevice
Also called Continuous Theta Burst Stimulation (cTBS)
This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Transcranial Magnetic Stimulation applied over the pre-supplementary motor area (pSMA), for ten sessions, Monday through Friday, over the course of two weeks. Receives: Device: Transcranial Magentic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)
Measured: Baseline and 6 months
Secondary outcomes (1)
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2022
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, Harvard University, University of Pittsburgh, University of Puerto Rico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704117
- Sponsor's protocol ID
- P50MH106435
- Status last verified
- Dec 2023
- First submitted
- 29 Feb 2016
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocircuitry of OCD: Effects Of Modulation
- ClinicalTrials.gov ID
- NCT02704117
- Acronym / sponsor ID
- P50MH106435
- Conditions
- Obsessive-Compulsive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- University of Rochester, Harvard University, University of Pittsburgh, University of Puerto Rico
- Study start
- Jun 2015
- Primary completion
- Sep 2022 (actual)
- Study completion
- Feb 2024 (estimated)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
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 effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain stimulation might change the functioning of regions implicated in OCD, and thereby inform possible future therapeutic uses.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | Device: Transcranial Magentic StimulationTranscranial Magnetic Stimulation applied over the pre-supplementary motor area (pSMA), for ten sessions, Monday through Friday, over the course of two weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current primary OCD diagnosis and current Y-BOCS total score of ≥16
- 18-70 years of age
- Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
- No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry
- Ongoing psychotherapy allowed if already established for three months or more before study entry
Key exclusion criteria (13 listed)
- History of primary psychotic disorder or bipolar disorder
- Present acute suicidality
- History of head injury, epilepsy, or other clinically significant neurological illness except tic disorders
- Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease
- Premorbid intelligence quotient (IQ) estimate < 80
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 Magentic StimulationAlso: Continuous Theta Burst Stimulation (cTBS)This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks | Device | Transcranial Magnetic Stimulation |
Primary outcome
Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)
Time frame: Baseline and 6 months
1 secondary outcome
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcranial Magentic Stimulation in people with Obsessive-Compulsive Disorder, run by Butler 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 Dec 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT) (time frame: Baseline and 6 months). 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 14 Dec 2023.