EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson's Disease

Not Applicable

Terminated

• Conditions: Parkinson
• Interventions: Other: Surface EMG; Other: Surface EMG, MRI and PET Scan

• Registration Number: NCT02896816
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

Study Purpose:

Parkinson's disease leads to severally impaired motor control. The purpose of this study is to better understand and analyze the characteristics of arm muscle activity while doing some reaching tasks and of leg muscles while walking. This will allow the investigators to improve understanding of the mechanisms underlying the motor impairments in Parkinson's disease.

Detailed Description

More details:

A total of 20 participants with Parkinson's disease and 20 age- and gender-matched healthy controls will be included in this study. The participants with Parkinson's disease should have symptoms only on one side of the body, and they should not be taking any dopamine replacement medication such as levodopa or dopamine agonists. The study will take place at the Motion Analysis Laboratory of Spaulding Rehabilitation Hospital in Charlestown, Massachusetts. It will consist of two assessment sessions; one where muscle activity of the arms as well as movement characteristics will be assessed during a reaching task; and another where muscle activity of the legs and movement characteristics will be assessed while walking on a treadmill. Clinical evaluations will also be performed. In addition, individuals with Parkinson's disease will undergo brain scans at Massachusetts General Hospital to examine whether there are any relationships between muscle activity and brain function.

Study Timeline

• Study First Submitted: 2016-06-29
• Study Start: 2016-08
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-12
• Primary Completion: 2021-05-25
• Study Completion: 2021-05-25
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control subjects	Surface EMG	Participants not affected by neurological disorders. Surface EMG will be performed at baseline.
Parkinson's subjects	Surface EMG, MRI and PET Scan	The participants with Parkinson's disease should have symptoms only on one side of the body, and they should not be taking any dopamine replacement medication such as levodopa or dopamine agonists. Surface EMG, MRI and PET scan will be performed at baseline.

Primary Outcome Measures

Name	Time	Method
Surface electromyography recording	Baseline	Surface EMG upper and lower extremities

Secondary Outcome Measures

Name	Time	Method
Functional MRI	Baseline	Resting state and task functional MRI will be performed to obtain BOLD signals.
Structural MRI	Baseline	T1 and T2 structural MRI will be performed.
Diffusion weighted imaging	Baseline	Diffusion weighted imaging will be performed to obtain connectivity measures.
Altropane PET scan	Baseline	Altropane PET scan will be performed to assess dopamine transport

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States