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Clinical Trials/NCT01485263
NCT01485263WithdrawnNot Applicable

Analysis of Visual-Motor Task Electrophysiological Activity During Deep Brain Stimulation for Treatment-Resistant Movement Disorders

National Institute of Neurological Disorders and Stroke (NINDS)0 sitesStarted: May 26, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
The primary objective of this trial is to evaluate and quantify neuronal coherence in basal ganglia structures at rest and during rewarded movement.

Study Overview

Brief Summary

Objective

The objective of this pilot study is to characterize the abnormal neuronal firing patterns of basal ganglia neurons and those in the premotor cortex in patients with treatment-resistant movement disorders undergoing deep brain stimulation (DBS) surgery.

Study population

Fifteen adult patients with treatment-resistant movement disorders who are undergoing deep brain stimulation surgery at Suburban Hospital, Bethesda, Maryland, will be studied.

Design

This is a physiology study of treatment-resistant movement disorder patients who have been scheduled for implantation of a deep brain stimulation device into the Nucleus accumbens. Prior to surgery, patients will learn a rewarded visual-motor task and undergo magnetoencephalography. The task will be repeated during DBS surgery, with collection of information on electrical activity including single neuronal unit and local field potentials. The task and MEG will be repeated 3-4 months after surgery. The collected data will be analyzed for coherence patterns during rest and rewarded movements.

Outcome measures

We plan to characterize and quantify the oscillatory activity present in motor circuits of treatment-resistant movement disorder patients during rewarded visually guided movements. We hypothesize that during visually guided movements, neuronal coherence will be significantly increased relative to resting periods. Thus, by better understanding the alteration in oscillatory patterns in these patients, we hope to develop better DBS stimulation paradigms in order to better treat this disease in the future.

Detailed Description

Objective:

The objective of this pilot study is to characterize the abnormal neuronal firing patterns of basal ganglia and thalamic neurons and those in the premotor cortex in patients with treatment-resistant movement disorders undergoing deep brain stimulation (DBS) surgery. Neuronal activity will be studied in a decision-making task guided by reward. Secondary objectives will involve study of how activity in the brain is modulated in such a task and how DBS can influence the cerebral activity related to decision-making.

Study population:

Fifteen adult patients with treatment-resistant movement disorders (Essential tremor or Parkinson s disease) who are undergoing deep brain stimulation surgery at Suburban Hospital, Bethesda, Maryland, will be studied.

Design:

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The primary objective of this trial is to evaluate and quantify neuronal coherence in basal ganglia structures at rest and during rewarded movement.

Secondary Outcomes

  • The latency and amplitude of evoked activity related to decision-making processing. We will also measure the reaction times and the number of errors.

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

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