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Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.
This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.
Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.
Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD patients. Efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep brain stimulation of subthalamic nucleus | Experimental | Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus |
|
| Deep brain stimulation of caudate nucleus | Experimental | Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation |
|
| Deep brain stimulation of nucleus accumbens | Experimental | Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Procedure | Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of symptoms after each phase | Severity as measured by the Yale-Brown Obsession and Compulsion scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of symptoms after each phase | Severity as measured by the Yale-Brown Obsession and Compulsion scale | month 0 |
| Severity of symptoms after each phase | Severity as measured by the Yale-Brown Obsession and Compulsion scale |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Luc Mallet, MD, PhD | Assitance Publique - Hopitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'investigation Clinique Pitié Salpêtrière | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 6 months |
| Severity of symptoms after each phase | Severity as measured by the Yale-Brown Obsession and Compulsion scale | 10 months |
| Severity of symptoms after each phase | Severity as measured by the Yale-Brown Obsession and Compulsion scale | 14 months |