Centre d'investigation Clinique Pitié Salpêtrière
Paris, 75013, France
NCT Number: NCT01807403
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 3
Paris, 75013, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Time frame: 3 months
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Time frame: month 0
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Time frame: 6 months
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Time frame: 10 months
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Time frame: 14 months
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Assistance Publique - Hôpitaux de Paris
Other
Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.
Acronym: PRESTOC2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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