Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106249
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2005-03-21
Brief Title:
Transcranial Magnetic Stimulation TMS and Obsessive Compulsive Disorder OCD
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Treatment of Obsessive Compulsive Disorder OCD With Transcranial Magnetic Stimulation TMS
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the clinical efficacy of functional Magnetic Resonance Imaging fMRI guided 1 Hz repetitive Transcranial Magnetic Stimulation rTMS applied to the Supplementary Motor Area SMA in OCD patients who have not fully responded to conventional therapies The investigators will collect TMS measures of motor cortex excitability to test whether rTMS restores normal levels of intracortical inhibition found to be deficient in OCD The investigators hypothesize that
1 Compared to sham placebo active rTMS will improve symptoms of OCD as assessed with the Yale Brown Obsessive Compulsive Scale Y-BOCS and Clinical Global Impression CGI
2 Active but not sham rTMS will normalize levels of motor cortex excitability as reflected by increased intracortical inhibition motor threshold and cortical silent period and by decreased intracortical facilitation relative to pre-treatment baseline
1 Compared to sham placebo active rTMS will improve symptoms of OCD as assessed with the Yale Brown Obsessive Compulsive Scale Y-BOCS and Clinical Global Impression CGI
2 Active but not sham rTMS will normalize levels of motor cortex excitability as reflected by increased intracortical inhibition motor threshold and cortical silent period and by decreased intracortical facilitation relative to pre-treatment baseline
Detailed Description:
This study tests the efficacy of functional Magnetic Resonance Imaging fMRI guided repetitive Transcranial Magnetic Stimulation rTMS in the treatment of Obsessive Compulsive Disorder OCD This study also examines measures of brain function that may inform us about the brain basis underlying OCD
Despite major advances in the study and treatment of OCD patients often do not respond or experience only partial remission from pharmacotherapy or cognitive behavioral therapy rTMS is a non-invasive procedure that allows stimulation of the brain using magnetic fields Some studies have reported that rTMS may be helpful in reducing obsessive and compulsive symptoms While promising prior research has several limitations eg relatively small sample sizes stimulation of sub-optimal target areas relatively short durations of treatment and lack of sham placebo comparison
This study addresses the drawbacks of prior work and will provide data that will be important in determining whether rTMS can be useful for OCD patients resistant to conventional therapies In this trial 32 adult outpatients with OCD that have been only partially responsive to conventional therapies will be randomly assigned to one of two treatment groups active low frequency 1 Hz rTMS or sham-placebo applied to the Supplementary Motor Area SMA daily for up to four weeks If rTMS will be added onto ongoing pharmacotherapy the doses must have been stable for 3 months prior to study entry The SMA was selected because of its connections with areas of the brain especially motor areas implicated in OCD Pilot work indicates that stimulation of SMA with low frequency rTMS was beneficial in OCD patients Low frequency rTMS has the added benefit of a better safety profile ie no risk of seizure compared to high frequency rTMS
Rating scales for symptom change will be obtained at baseline during the rTMS course and at the end of 4 weeks of treatment Patients who do not meet response criteria after four weeks of sham and partial responders to either active or sham will be offered an open-label cross-over phase for an additional four weeks of daily active rTMS treatment Patients who meet response criteria in either the randomized phase or the cross-over phase will continue routine clinical care under the supervision of their treating psychiatrist and will be invited back for a repeat assessment at 3 and 6 months to determine the persistence of benefit
Measures of the excitability of the motor cortex have been reported to be abnormal in OCD and may relate to dysfunction in motor pathways related to OCD circuits We will collect measures of motor cortex excitability performed with single pulse TMS at baseline and after treatment to determine whether changes in these measures may be correlated with clinical improvement
Despite major advances in the study and treatment of OCD patients often do not respond or experience only partial remission from pharmacotherapy or cognitive behavioral therapy rTMS is a non-invasive procedure that allows stimulation of the brain using magnetic fields Some studies have reported that rTMS may be helpful in reducing obsessive and compulsive symptoms While promising prior research has several limitations eg relatively small sample sizes stimulation of sub-optimal target areas relatively short durations of treatment and lack of sham placebo comparison
This study addresses the drawbacks of prior work and will provide data that will be important in determining whether rTMS can be useful for OCD patients resistant to conventional therapies In this trial 32 adult outpatients with OCD that have been only partially responsive to conventional therapies will be randomly assigned to one of two treatment groups active low frequency 1 Hz rTMS or sham-placebo applied to the Supplementary Motor Area SMA daily for up to four weeks If rTMS will be added onto ongoing pharmacotherapy the doses must have been stable for 3 months prior to study entry The SMA was selected because of its connections with areas of the brain especially motor areas implicated in OCD Pilot work indicates that stimulation of SMA with low frequency rTMS was beneficial in OCD patients Low frequency rTMS has the added benefit of a better safety profile ie no risk of seizure compared to high frequency rTMS
Rating scales for symptom change will be obtained at baseline during the rTMS course and at the end of 4 weeks of treatment Patients who do not meet response criteria after four weeks of sham and partial responders to either active or sham will be offered an open-label cross-over phase for an additional four weeks of daily active rTMS treatment Patients who meet response criteria in either the randomized phase or the cross-over phase will continue routine clinical care under the supervision of their treating psychiatrist and will be invited back for a repeat assessment at 3 and 6 months to determine the persistence of benefit
Measures of the excitability of the motor cortex have been reported to be abnormal in OCD and may relate to dysfunction in motor pathways related to OCD circuits We will collect measures of motor cortex excitability performed with single pulse TMS at baseline and after treatment to determine whether changes in these measures may be correlated with clinical improvement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None