Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057603
Status:
COMPLETED
Last Update Posted:
2011-11-09
First Post:
2003-04-04
Brief Title:
Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Pilot Study of DBS for Treatment-Refractory OCD
Status:
COMPLETED
Status Verified Date:
2011-11
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 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
Detailed Description:
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
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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A5-ETMA | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH064161 |
| R21MH064161 | NIH | None | None |