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

July 7, 2017 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

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.

Study Overview

Status

Withdrawn

Conditions

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:

This is a physiology study of medically refractory patients who have been scheduled for implantation of a deep brain stimulation device into basal ganglia or thalamic structures. Prior to surgery, patients will learn a rewarded visual-motor task and undergo magnetoencephalography (MEG). 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 and 6 months after surgery.

Outcome measures:

The collected data will be analyzed for coherence patterns during rest and rewarded movements. We plan to characterize and quantify the oscillatory activity present in motor circuits of patients during rewarded visually guided movements. We hypothesize that during visually guided movements, neuronal coherence will be significantly increased relative to resting periods. Activity during surgery will be compared with MEG recordings in the same task both before and after surgery. By understanding the alteration in oscillatory patterns in these patients, we hope to improve DBS stimulation paradigms in order to optimize treatment protocols.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Adult patients (over 18 years of age) with severe treatment-resistant ET or PD who are scheduled for deep brain stimulation surgery at Suburban Hospital

Able to provide Informed Consent

EXCLUSION CRITERIA:

Subjects who are not willing or able to safely tolerate the study procedures

Subjects who have untreated depression or psychiatric disorder

Subjects who use illicit substances

Subjects who are pregnant

Subjects who are claustrophobic

Subjects who have metallic dental fillings.

Subjects who have any of the following: cardiac pacemaker; implanted cardiac defibrillator; aneurysm clip; neuro or bone stimulator; insulin or infusion pump; implanted drug infusion device; cochlear, otologic, or ear implant; prostate radiation seeds; IUD (intrauterine device); transdermal medication patch (Nitro); any type of prosthesis (eye, penile); heart valve prosthesis; shunt (spinal/intraventricular); wire sutures or surgical staples; bone/joint pin, screw, nail, plate; body tattoos or makeup (eyeliner/lip); body piercing(s) (non-removable); breast tissue expander; any metallic implants or objects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators

George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 26, 2011

Study Completion

July 6, 2017

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 2, 2011

First Posted (Estimate)

December 5, 2011

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 7, 2017

Last Verified

July 6, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110157
  • 11-N-0157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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