Obsessive-Compulsive DisorderNCT02904356
Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)
A study testing Repetitive transcranial magnetic stimulation in people with Obsessive-Compulsive Disorder, run by Columbia University at 1 site in United States.
Trial summary
The study aims to assess the impact of repetitive transcranial magnetic stimulation (rTMS) on brain imaging and neurophysiological measures of cognitive control in patients with Obsessive-Compulsive Disorder (OCD). 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?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Oct 2018
- 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
- Primary diagnosis of Obsessive Compulsive Disorder, as confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) (SCID).
- Subjects should have at least a moderate level of OCD severity as defined by a Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) score of ≥ 20.
Who cannot join
- Individuals diagnosed by the investigators with the following conditions: Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime), history of substance abuse or dependence within the past year (expect nicotine and caffeine).
- An Axis II Personality Disorder, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol.
- Individuals with a clinically defined neurological disorder including, but not limited to: stroke, tics, space occupying brain lesion, any history of seizures except those therapeutically induced by electroconvulsive therapy (ECT), history of cerebrovascular accident, transient ischemic attack within two years, cerebral aneurysm, dementia, Parkinson's Disease, Huntington Chorea, Multiple Sclerosis.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for >5 minutes.
- History of treatment with rTMS therapy for any disorder.
- History of treatment with Deep Brain Stimulation.
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- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- Current illicit drug use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
The study aims to assess the impact of repetitive transcranial magnetic stimulation (rTMS) on brain imaging and neurophysiological measures of cognitive control in patients with Obsessive-Compulsive Disorder (OCD).
Read the detailed description
With a prevalence of nearly 3%, obsessive-compulsive disorder (OCD) is one of the most common psychiatric disorders in the US. The first line of treatment for OCD comprises pharmacotherapy with serotonin reuptake inhibitors (SRIs) and cognitive behavioral therapy (CBT). Although adherence to these therapies has been shown to improve symptoms in at least half of patients, some have residual symptoms and a small percentage are refractory to standard therapies. Transcranial magnetic stimulation (TMS) may offer an alternate, less-invasive therapy.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- OCD, TMS, Neuromodulation, Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Imaging
- 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.
Repetitive transcranial magnetic stimulationDevice
Also called rTMS
High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT).
| Study group | Role | What they receive |
|---|---|---|
| Brainsway H-coil for rTMS | Experimental | Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks. Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Response
Change in blood-oxygen-level dependent (BOLD) correlates corresponding to task engagement before and after rTMS will be assessed.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018
- Study completionOct 2018
Why it stopped: PI left institution
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.
- More trials run by Columbia UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sameer Sheth, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904356
- Sponsor's protocol ID
- AAAQ8771
- Status last verified
- Nov 2019
- First submitted
- 25 Aug 2016
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT02904356
- Acronym / sponsor ID
- AAAQ8771
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, TMS, Neuromodulation, Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Posted 25 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the impact of repetitive transcranial magnetic stimulation (rTMS) on brain imaging and neurophysiological measures of cognitive control in patients with Obsessive-Compulsive Disorder (OCD).
Detailed description
With a prevalence of nearly 3%, obsessive-compulsive disorder (OCD) is one of the most common psychiatric disorders in the US. The first line of treatment for OCD comprises pharmacotherapy with serotonin reuptake inhibitors (SRIs) and cognitive behavioral therapy (CBT). Although adherence to these therapies has been shown to improve symptoms in at least half of patients, some have residual symptoms and a small percentage are refractory to standard therapies. Transcranial magnetic stimulation (TMS) may offer an alternate, less-invasive therapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brainsway H-coil for rTMS | Experimental | Device: Repetitive transcranial magnetic stimulationBrainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of Obsessive Compulsive Disorder, as confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) (SCID).
- Subjects should have at least a moderate level of OCD severity as defined by a Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) score of ≥ 20.
Key exclusion criteria (9 listed)
- Individuals diagnosed by the investigators with the following conditions: Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime), history of substance abuse or dependence within the past year (expect nicotine and caffeine).
- An Axis II Personality Disorder, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol.
- Individuals with a clinically defined neurological disorder including, but not limited to: stroke, tics, space occupying brain lesion, any history of seizures except those therapeutically induced by electroconvulsive therapy (ECT), history of cerebrovascular accident, transient ischemic attack within two years, cerebral aneurysm, dementia, Parkinson's Disease, Huntington Chorea, Multiple Sclerosis.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for >5 minutes.
- History of treatment with rTMS therapy for any disorder.
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationAlso: rTMSHigh-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT). | Device | Brainsway H-coil for rTMS |
Primary outcome
Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Response
Time frame: Up to 1 month
Change in blood-oxygen-level dependent (BOLD) correlates corresponding to task engagement before and after rTMS will be assessed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sameer Sheth, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Obsessive-Compulsive Disorder, run by Columbia University 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Nov 2019. 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 25 Nov 2019). 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 Functional Magnetic Resonance Imaging (fMRI) BOLD Response (time frame: Up to 1 month). 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 25 Nov 2019.