Electrophysiological Recording for Patients Receiving Deep Brain Stimulation Electrode for Treatment-resistant Obsessive-compulsive Disorder

Obsessive-compulsive Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429558
• Other study ID #: 11-0290-03
• Status: Completed
• Phase: N/A
• First received: September 4, 2011
• Last updated: April 23, 2013
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this project is to study live recordings from neuronal population of the human nucleus accumbens during the implantation of deep brain stimulation (DBS) electrodes for the treatment-resistant obsessive compulsive disorder (OCD). The central aim of this project is to determine if intra-operative electrophysiological data can confirm that the electrode is located in the nucleus accumbens. This confirmation could allow the placement of the DBS electrodes with a higher degree of precision. An additional aim of this project will be to study the activity of the neuronal population of the nucleus accumbens while a subject is presented with a task involving an unexpected reward.

The investigators central hypothesis is that unexpected reward will be associated with increase firing and synchrony in the neuronal population. This will translate into recordable increase activity in the investigators region of interest and therefore confirm the proper placement of the electrode.

This study enrolled 2 subjects, with 1 subject completing the protocol showing the feasibility of the experiment. There were electrophysiological variations with the task presented but no conclusion could be drawn given the small sample size.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Treatment-resistant OCD

• Failure of psychotherapy

• Failure of pharmacotherapy

• Meets inclusion criteria for DBS implant in OCD

Exclusion Criteria:

• Significant substance use disorder

• Significant personality disorder

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States,