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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:
ClinicalTrials.gov Identifier:
NCT01429558
First Posted: September 7, 2011
Last Update Posted: April 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jean-Philippe Langevin, University of Arizona
  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:


Further study details as provided by Jean-Philippe Langevin, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429558


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

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
First Submitted: September 4, 2011
First Posted: September 7, 2011
Last Update Posted: April 24, 2013
Last Verified: April 2013

Keywords provided by Jean-Philippe Langevin, University of Arizona:
treatment resistant obsessive-compulsive disorder

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


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