Subthalamic Deep Brain Stimulation (DBS) in Parkinson's Disease

NCT02012647 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-09-09

No results posted yet for this study

Summary

The purpose of this study is to examine the brain changes in people with Parkinson's Disease (PD) after they get deep brain stimulation (DBS) surgery, compared with people who do not have Parkinson's Disease. Treatment of Parkinson's disease is often difficult and challenging. Deep brain stimulation is an established surgical treatment that is effective for the treatment of PD, but the details of why it helps are not known. In order to achieve maximum benefits from this treatment, it is important to understand how it changes the brain. Specifically, the investigators will study electrophysiology, which is the study of how the brain conducts electrical messages to the rest of the body. To do this, the investigators will use transcranial magnetic stimulation (TMS), which is a painless and non-invasive procedure. They will also conduct motor physiology experiments of the upper and lower limbs to collect data about skeletal muscle movement. The data from this study will help explain whether the electrical changes in the brain have any relation to the physical benefits patients with Parkinson's Disease sometimes receive from DBS surgery.

Conditions

Interventions

PROCEDURE

Transcranial Magnetic Stimulation (TMS)

Participants sit in a chair that looks like one in a dentist's office. A magnetic coil will be placed on the scalp on one side of the head, overlying the brain's motor cortex to stimulate the brain's output to the muscles in the opposite hand. A second magnetic coil will be placed on the scalp of the opposite side. Recordings from both hands will be made using the magnetic coils placed on scalp. Results will be compared for participants with and without Parkinson's Disease.

PROCEDURE

Motor Physiology Testing

Participants will be asked to move their upper and lower limbs while seated in a chair. Wireless EMG sensors placed on arm and leg muscles will record measurements during this procedure. Upper and lower limb testing will be performed separately.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Aparna Wagle Shukla, MD · University of Florida Center for Movement Disorders and Neurorestoration

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-03-31
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02012647 on ClinicalTrials.gov