Obsessive-Compulsive DisorderNCT02541812
The Use of Magnetic Brain Stimulation to Treat Obsessive Compulsive Disorder, a Pilot Study
A study testing Transcranial Magnetic Stimulation in people with Obsessive-Compulsive Disorder, run by University of Manitoba.
Trial summary
The purpose of this study is two-fold: first, to observe the effect of one session of repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and second, to observe the clinical effect of 10 sessions of… 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?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Jun 2015
- 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
- Diagnosed obsessive compulsive disorder
- Not currently receiving cognitive behavioural therapy
- Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)
Who cannot join
- History of psychotic episodes
- History of neurological illness
- Previous head injury
- Active alcohol or substance abuse
- History of seizure disorders
- Currently pregnant
About this study
Official title: The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder (OCD), a Pilot Study
The purpose of this study is two-fold: first, to observe the effect of one session of repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and second, to observe the clinical effect of 10 sessions of rTMS in patients with OCD.
Read the detailed description
A battery of cognitive tasks designed to selectively measure several aspects of anterior cingulate cortex (ACC) function, will be administered before and after one session of rTMS in all participants. The first neurocognitive session will be administered in a separate day from the rTMS session. The second neurocognitive session will be performed immediately after rTMS and in the same day. Participants will perform five tasks designed to test: error processing, error likelihood assessment, meta-memory, response inhibition, and affect recognition.
The rTMS paradigm will consist of four short trains of magnetic pulses which include 5 minutes of stimulation with 1Hz frequency (overall 1200 pulses in one session) with an intensity of 110% of each participant's motor threshold, and 2 minute intervals between the stimulation trains. Stimulation will be applied over the dorsal ACC (dACC) using a double-cone rTMS coil. dACC will be precisely targeted using neuronavigation software loaded a high resolution MRI of each subjects' brain.
OCD patients will go on to receive two weeks (10 sessions) of daily rTMS treatments using the same protocol described above.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Error processing
- 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
A non-invasive method for brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder Receives: Device: Transcranial Magnetic Stimulation |
| Healthy Control Subjects | Active comparator | One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)
Yale-Brown Obsessive Compulsive Scale. Minimum value = 0. Maximum value = 40. Higher scores indicate greater severity of obsessive and compulsive symptoms.
Measured: Recordings: baseline; after two weeks of rTMS
Secondary outcomes (1)
Change in Post-error Slowing
Post-error slowing (PES) is the difference in response time on trials following an error to trials following a correct response. Higher numbers indicate more post-error slowing (i.e. longer response times following an error trial compared to following a correct trial). The outcome measure is the change in PES from baseline to following one session of rTMS.
Measured: Recordings: baseline; after one session of rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionJun 2015
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 University of ManitobaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mandana Modirrousta, MD PhD FRCPC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541812
- Sponsor's protocol ID
- B2009:077
- Status last verified
- Aug 2015
- First submitted
- 2 Sep 2015
- Last updated
- 17 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Modirrousta M, Meek BP, Sareen J, Enns MW. Impaired trial-by-trial adjustment of cognitive control in obsessive compulsive disorder improves after deep repetitive transcranial magnetic stimulation. BMC Neurosci. 2015 Oct 9;16:63. doi: 10.1186/s12868-015-0205-z.
PubMed 26453446
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder (OCD), a Pilot Study
- ClinicalTrials.gov ID
- NCT02541812
- Acronym / sponsor ID
- B2009:077
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Error processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Posted 27 Aug 2020
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 two-fold: first, to observe the effect of one session of repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and second, to observe the clinical effect of 10 sessions of rTMS in patients with OCD.
Detailed description
A battery of cognitive tasks designed to selectively measure several aspects of anterior cingulate cortex (ACC) function, will be administered before and after one session of rTMS in all participants. The first neurocognitive session will be administered in a separate day from the rTMS session. The second neurocognitive session will be performed immediately after rTMS and in the same day. Participants will perform five tasks designed to test: error processing, error likelihood assessment, meta-memory, response inhibition, and affect recognition.
The rTMS paradigm will consist of four short trains of magnetic pulses which include 5 minutes of stimulation with 1Hz frequency (overall 1200 pulses in one session) with an intensity of 110% of each participant's motor threshold, and 2 minute intervals between the stimulation trains. Stimulation will be applied over the dorsal ACC (dACC) using a double-cone rTMS coil. dACC will be precisely targeted using neuronavigation software loaded a high resolution MRI of each subjects' brain.
OCD patients will go on to receive two weeks (10 sessions) of daily rTMS treatments using the same protocol described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Transcranial Magnetic StimulationTen sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder |
| Healthy Control Subjects | Active comparator | Device: Transcranial Magnetic StimulationOne session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed obsessive compulsive disorder
- Not currently receiving cognitive behavioural therapy
- Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)
Key exclusion criteria (6 listed)
- History of psychotic episodes
- History of neurological illness
- Previous head injury
- Active alcohol or substance abuse
- History of seizure disorders
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 StimulationA non-invasive method for brain stimulation | Device | Healthy Control Subjects, Patients |
Primary outcome
Change in Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)
Time frame: Recordings: baseline; after two weeks of rTMS
Yale-Brown Obsessive Compulsive Scale. Minimum value = 0. Maximum value = 40. Higher scores indicate greater severity of obsessive and compulsive symptoms.
1 secondary outcome
Change in Post-error Slowing
Time frame: Recordings: baseline; after one session of rTMS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26453446Modirrousta M, Meek BP, Sareen J, Enns MW. Impaired trial-by-trial adjustment of cognitive control in obsessive compulsive disorder improves after deep repetitive transcranial magnetic stimulation. BMC Neurosci. 2015 Oct 9;16:63. doi: 10.1186/s12868-015-0205-z.
Related trials for Obsessive-Compulsive Disorder
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
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.
Mandana Modirrousta, MD PhD FRCPC principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Obsessive-Compulsive Disorder, run by University of Manitoba.
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 3 inclusion and 6 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 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 27 Aug 2020). 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 Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale) (time frame: Recordings: baseline; after two weeks of rTMS). 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 NCT02541812, 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 17 Sep 2020.