Obsessive-Compulsive DisorderPhase 2TMS-TOCNCT00822601
Study of Repetitive Transcranial Magnetic Stimulation Efficacy on Obsessive Compulsive Disorder (OCD)
A Phase 2 study testing rTMS in people with Obsessive-Compulsive Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Our study's purpose is to show the efficacy of the transcranial magnetic stimulation (a non invasive method of cerebral modulation) in patients suffering from chronic 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?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Apr 2012
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed patient informed consent;
- primary obsessive compulsive disorder;
- current YBOCS score at least 15 with or without drug (or obsessive/compulsive subscores of at least 10);
- males/females 18-65yrs;
- treated with at least two adequate dose of SRI at least 8 weeks at some stage of illness;
- currently using adequate, stable dose of SSRI at least 8 weeks but not responding.
Who cannot join
- schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (MADRS>20), substance/alcohol dependence within last 6 months;
- severe axis II;
- significant suicide risk;
- metallic implant in cranium;
- severe/unstable medical conditions;
- ECT in the last month;
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- pregnancy or breastfeeding ;
- history epilepsy; neurological disorder leading to increased intracranial pressure; severe cardiac disorder/intracardiac lines, pacemakers; Gilles de la Tourette syndrome;
- current structured psychotherapy;
- current drug treatment of bipolar disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Study of rTMS Over Supplementary Motor Area (SMA) in Obsessive Compulsive Disorder
Our study's purpose is to show the efficacy of the transcranial magnetic stimulation (a non invasive method of cerebral modulation) in patients suffering from chronic obsessive compulsive disorder (OCD). This new method will be applied in 20 patients during 4 weeks (5 sessions each week), and its effects on OCD symptoms will be compared to those of a "sham" (=placebo) stimulation applied with the same process in 20 other patients, randomly assigned to the comparison group. The maintenance of the therapeutic effects will be explored during 8 weeks following the end of the treatment. In addition to classical scales used to measure the treatment effects, all patients will be examined using a functional magnetic resonance imaging (fMRI) before and after treatment to explore the cerebral effects of rTMS
Read the detailed description
Repetitive Transcranial Magnetic Stimulation (rTMS) has been shown to be an effective therapeutic tool for the treatment of several neuropsychiatric disorders including major depression and hallucinations in schizophrenia but, to date, studies exploring the effects of rTMS in Obsessive Compulsive Disorder (OCD) have produce negative or conflicting results, especially those applying the stimulation to the prefrontal cortex as for the treatment of depression. However, a promising result has been obtained in a study in which the rTMS was applied to the Supplementary Motor Area (SMA), but in a small size and heterogeneous sample. The SMA has connections with areas of the brain, especially motor areas and subcortical-limbic circuitry, implicated in OCD.
In our study, 40 adult outpatients with OCD, who have been insufficiently responsive to at least two recognized drug treatments, will be randomly assigned to one of two treatment groups (active low frequency (1 Hz, 100% of the motor threshold) rTMS or sham-placebo) applied to the SMA daily for up to four weeks. An individual MRI-guided neuronavigation will be used to precisely define the target stimulation site in each patient. Rating scales for symptom change will be obtained at baseline, during the rTMS course, at the end of 4 weeks of treatment, and after a 2-month follow-up period. The main outcome measure will be the Yale-Brown Obsessive Compulsive scale, and secondary outcome measure will include the CGI scales, the LPO scale, the MOCI, and the SDS. Brain activity changes in fMRI before and after active/sham treatment will be compared between groups, with rest measures and provocation tasks.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- rTMS, Sham Comparator
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Supplementary Motor Area, Obsessive-Compulsive Disorder, Sham rTMS, Placebo-controlled, Randomized, Double-blind, fMRI, DSM-IV Obsessive-Compulsive Disorder
- 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.
rTMSDevice
Arm 1 (experimental) : rTMS, 4 weeks of stimulation with RMT frequency 1Hz, intensity 100% of RMT for 20 minutes (1500 pulses), 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks.
Sham ComparatorDevice
sham rTMS (using a placebo coil), 4 weeks of stimulation, will mimic the active treatment mentioned above.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: rTMS |
| 2 | Placebo comparator | Not described Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Measured: week 1, 2, 3, 4, 5, 7, 9, 11, 13
Secondary outcomes (9)
Clinical Global Impression - Severity (CGI-S)
Measured: week 1, 2, 3, 4, 5, 7, 9, 11, 13
- Clinical Global Impression - Improvement (CGI-I)
Measured: week 1, 2, 3, 4, 5, 7, 9, 11, 13
Global Assessment of Functioning (GAF)
Measured: week 5, 13
- Montgomery Asberg Depression Rating Scale (MADRS)
Measured: week 5, 13
Brief Anxiety Scale (BAS
Measured: week 5, 13
Sheehan Disability Scale (SDS)
Measured: , week 5, 13
Hospital Anxiety and Depression (HAD) scale
Measured: week 1, 2, 3, 4, 5, 7, 9, 11, 13
Maudsley Obsessional Inventory (MOCI)
Measured: week 5, 13
LPO scale
Measured: week 5, 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2012
- Study completionApr 2012
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Pelissolo, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822601
- Sponsor's protocol ID
- AOR07067
- Acronym
- TMS-TOC
- Status last verified
- Jan 2009
- First submitted
- 13 Jan 2009
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study of rTMS Over Supplementary Motor Area (SMA) in Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00822601
- Acronym / sponsor ID
- TMS-TOC / AOR07067
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Supplementary Motor Area, Obsessive-Compulsive Disorder, Sham rTMS, Placebo-controlled, Randomized, Double-blind, fMRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 14 Jan 2009 (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.
Our study's purpose is to show the efficacy of the transcranial magnetic stimulation (a non invasive method of cerebral modulation) in patients suffering from chronic obsessive compulsive disorder (OCD). This new method will be applied in 20 patients during 4 weeks (5 sessions each week), and its effects on OCD symptoms will be compared to those of a "sham" (=placebo) stimulation applied with the same process in 20 other patients, randomly assigned to the comparison group. The maintenance of the therapeutic effects will be explored during 8 weeks following the end of the treatment. In addition to classical scales used to measure the treatment effects, all patients will be examined using a functional magnetic resonance imaging (fMRI) before and after treatment to explore the cerebral effects of rTMS
Detailed description
Repetitive Transcranial Magnetic Stimulation (rTMS) has been shown to be an effective therapeutic tool for the treatment of several neuropsychiatric disorders including major depression and hallucinations in schizophrenia but, to date, studies exploring the effects of rTMS in Obsessive Compulsive Disorder (OCD) have produce negative or conflicting results, especially those applying the stimulation to the prefrontal cortex as for the treatment of depression. However, a promising result has been obtained in a study in which the rTMS was applied to the Supplementary Motor Area (SMA), but in a small size and heterogeneous sample. The SMA has connections with areas of the brain, especially motor areas and subcortical-limbic circuitry, implicated in OCD.
In our study, 40 adult outpatients with OCD, who have been insufficiently responsive to at least two recognized drug treatments, will be randomly assigned to one of two treatment groups (active low frequency (1 Hz, 100% of the motor threshold) rTMS or sham-placebo) applied to the SMA daily for up to four weeks. An individual MRI-guided neuronavigation will be used to precisely define the target stimulation site in each patient. Rating scales for symptom change will be obtained at baseline, during the rTMS course, at the end of 4 weeks of treatment, and after a 2-month follow-up period. The main outcome measure will be the Yale-Brown Obsessive Compulsive scale, and secondary outcome measure will include the CGI scales, the LPO scale, the MOCI, and the SDS. Brain activity changes in fMRI before and after active/sham treatment will be compared between groups, with rest measures and provocation tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: rTMS |
| 2 | Placebo comparator | Device: Sham Comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed patient informed consent;
- primary obsessive compulsive disorder;
- current YBOCS score at least 15 with or without drug (or obsessive/compulsive subscores of at least 10);
- males/females 18-65yrs;
- treated with at least two adequate dose of SRI at least 8 weeks at some stage of illness;
Key exclusion criteria (10 listed)
- schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (MADRS>20), substance/alcohol dependence within last 6 months;
- severe axis II;
- significant suicide risk;
- metallic implant in cranium;
- severe/unstable medical conditions;
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 |
|---|---|---|
| rTMSArm 1 (experimental) : rTMS, 4 weeks of stimulation with RMT frequency 1Hz, intensity 100% of RMT for 20 minutes (1500 pulses), 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks. | Device | 1 |
| Sham Comparatorsham rTMS (using a placebo coil), 4 weeks of stimulation, will mimic the active treatment mentioned above. | Device | 2 |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13
9 secondary outcomes
Clinical Global Impression - Severity (CGI-S)
Time frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13
- Clinical Global Impression - Improvement (CGI-I)
Time frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13
Global Assessment of Functioning (GAF)
Time frame: week 5, 13
- Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: week 5, 13
Brief Anxiety Scale (BAS
Time frame: week 5, 13
Sheehan Disability Scale (SDS)
Time frame: , week 5, 13
Hospital Anxiety and Depression (HAD) scale
Time frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13
Maudsley Obsessional Inventory (MOCI)
Time frame: week 5, 13
LPO scale
Time frame: week 5, 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
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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.
Antoine Pelissolo, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rTMS in people with Obsessive-Compulsive Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 31 Jul 2012. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Yale-Brown Obsessive Compulsive Scale (YBOCS) (time frame: week 1, 2, 3, 4, 5, 7, 9, 11, 13). 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 31 Jul 2012.