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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean-Philippe Langevin, University of Arizona
ClinicalTrials.gov Identifier:
NCT01429558
First received: September 4, 2011
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Obsessive-compulsive Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arizona:

Enrollment: 2
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The subjects in this study are suffering from treatment-resistant OCD

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429558

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
  More Information

No publications provided

Responsible Party: Jean-Philippe Langevin, Assistant clinical professor of surgery, University of Arizona
ClinicalTrials.gov Identifier: NCT01429558     History of Changes
Other Study ID Numbers: 11-0290-03
Study First Received: September 4, 2011
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
treatment resistant obsessive-compulsive disorder

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013