CI

At a glance

ClinicalIndex Comparison Record
Phase 4Active· 27 enrolled
Drug / intervention
Active DBS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00640133
NCT00640133Phase 4Active
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Controlled Trial of Deep Brain Stimulation for Obsessive-Compulsive Disorder

Butler Hospital·interventional·Posted Mar 21, 2008·Updated Jul 29, 2024

In Brief

A Phase 4 clinical trial evaluating Active DBS and Sham DBS for Obsessive-Compulsive Disorder. Active but no longer recruiting, targeting 27 participants across 9 sites.

Detailed Summary

This study will evaluate the safety and effectiveness of deep brain stimulation in treating people with severe and otherwise treatment-resistant obsessive-compulsive disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObsessive-Compulsive Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 4ActiveOverdue
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2008
Enrollment StartMar 1, 2008
Primary CompletionMay 24, 2018
Study CompletionDec 1, 2024
TodayJul 2, 2026
Enrollment to primary: 10.2 yearsPosted 18.3 years ago

Interventions

Active DBSdevice

In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant. After a post-operative rest, participants will receive immediate DBS treatment throughout.

Sham DBSdevice

In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will mimic adjusting the settings of the electrical stimulation. After a post-operative rest, participants will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS.