Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21MH064161 | U.S. NIH Grant/Contract | View source | |
| DATR A5-ETMA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the use of Deep Brain Stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-resistant obsessive compulsive disorder (OCD).
Despite advances in pharmacological and behavioral therapies for OCD, a substantial number of patients fail to improve significantly following years of conventional and experimental interventions. For some patients, stereotactic neurosurgery is the only promising option available. Although this procedure has relatively few side effects in the majority of OCD patients and may lead to enduring benefits, its effects on brain tissue and function are irreversible. Bilateral deep brain stimulation (DBS) is an adjustable and partially reversible procedure that may be a more effective treatment for patients with OCD. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory OCD.
Participants receive DBS treatment for 30 months. Obsessive Compulsive scales, depression scales, neuropsychological evaluations, and surveys are used to assess participants.
Participants are monitored for 2 years after DBS treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation | Experimental | Participants receive deep brain stimulation treatment for 30 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Procedure | Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey | Measured pre- and post-intervention |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Herbert Ward, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22305344 | Derived | Vora AK, Ward H, Foote KD, Goodman WK, Okun MS. Rebound symptoms following battery depletion in the NIH OCD DBS cohort: clinical and reimbursement issues. Brain Stimul. 2012 Oct;5(4):599-604. doi: 10.1016/j.brs.2011.10.004. Epub 2011 Nov 4. | |
| 20116047 | Derived | Goodman WK, Foote KD, Greenberg BD, Ricciuti N, Bauer R, Ward H, Shapira NA, Wu SS, Hill CL, Rasmussen SA, Okun MS. Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Biol Psychiatry. 2010 Mar 15;67(6):535-42. doi: 10.1016/j.biopsych.2009.11.028. Epub 2010 Feb 8. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided