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

September 4, 2011
April 23, 2013
August 2011
October 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01429558 on ClinicalTrials.gov Archive Site
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Electrophysiological Recording for Patients Receiving Deep Brain Stimulation Electrode for Treatment-resistant Obsessive-compulsive Disorder
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Obsessive-compulsive Disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01429558
11-0290-03
No
Jean-Philippe Langevin, University of Arizona
University of Arizona
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University of Arizona
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP