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

NCT02012647 | Completed Early Phase 1 DMC

• 2 other identifiers: 21-201340115065-2
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Parkinson's Disease

Keywords

parkinson; PD; parkinson disease; parkinson's; parkinson's disease; parkinsons; parkinsons disease; TMS; DBS; transcranial magnetic stimulation; deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Motor Cortex Excitability

  We will measure Motor Cortex Excitability by examining circuitries of inhibition found in the motor cortex which have a reduced function in Parkinson's Disease.

  As few as 1 days and up to 4 months

Secondary Outcomes (3)

• Relation between Unified Parkinson's Disease Rating Scale outcomes and physiological measures

  As few as 2 days and up to 4 months

• Transcallosal Pathway Excitability

  As few as 2 days and up to 4 months

• Physiological Measures

  One day

Study Arms (2)

People with Parkinsons Disease

ACTIVE COMPARATOR

Participants have been diagnosed with Parkinson's Disease, and as recommended by their physicians, have undergone DBS surgery for both sides of the brain. These participants will undergo TMS and motor physiology testing, and results will be compared to participants without Parkinson's Disease.

Procedure: Transcranial Magnetic Stimulation (TMS); Procedure: Motor Physiology Testing

Healthy Controls

PLACEBO COMPARATOR

These participants do not have Parkinson's Disease, nor have they had DBS surgery, and are a healthy controls. These participants will undergo TMS and motor physiology testing, and results will be compared to participants with Parkinson's Disease.

Procedure: Transcranial Magnetic Stimulation (TMS); Procedure: Motor Physiology Testing

Interventions

Transcranial Magnetic Stimulation (TMS) PROCEDURE

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.

Healthy Controls; People with Parkinsons Disease

Motor Physiology Testing PROCEDURE

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.

Healthy Controls; People with Parkinsons Disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years
• Diagnosis of Parkinson's Disease with bilateral subthalamic nucleus (STN) DBS

You may not qualify if:

• Cardiac pacemakers
• Need for diathermy
• Repeat MRI scanning
• Anticoagulant therapy
• Previous neuro surgical procedure or ablative therapy
• Frank dementia according to cognitive screening
• History of seizures
• Pregnancy
• Presence of a terminal illness

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32607, United States

Location

Related Links

• UF Center for Movement Disorders \& Neurorestoration

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Aparna Wagle Shukla, MD

  University of Florida Center for Movement Disorders and Neurorestoration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: December 16, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

US (1)