Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01485263

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

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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: 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.

Conditions

Timeline

Start date
2011-05-26
Completion
2017-07-06
First posted
2011-12-05
Last updated
2017-07-11

Source: ClinicalTrials.gov record NCT01485263. Inclusion in this directory is not an endorsement.