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

Overview

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.

Full Title of Study: “EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2019

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.

Interventions

  • Other: Surface EMG, MRI and PET Scan
    • 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.
  • Other: Surface EMG
    • 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.

Arms, Groups and Cohorts

  • Experimental: Parkinson’s subjects
    • 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.
  • Active Comparator: Control subjects
    • Participants not affected by neurological disorders. Surface EMG will be performed at baseline.

Clinical Trial Outcome Measures

Primary Measures

  • Surface electromyography recording
    • Time Frame: Baseline
    • Surface EMG upper and lower extremities

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria for Parkinson's volunteers:

1. Male and female, age 18-80

2. Motor symptoms only on one side of the body

3. No use of dopaminergic replacement therapy or other medication related to PD

Exclusion Criteria for Parkinson's volunteers:

1. Cognitive impairments that may interfere with understanding instructions as needed during the performance of the study (MMSE<23)

2. Subjects who are unable to perform arm reaching movements

3. Self-report of any condition that could affect walking

4. No fractures or skin lesions in the upper or lower limbs

5. Infectious diseases requiring contact precautions

6. Subjects with contraindications to MRI cannot participate (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia)

7. Pregnancy: If the possibility of pregnancy of a female participant cannot be excluded by: 1) surgical history (e.g., tubal ligation or hysterectomy) or 2) post menopausal status with a minimum of 1 year without menses, then a pregnancy test by stat serum testing must be performed on site the morning of any PET visit and the negative result is required prior to the administration or any radiopharmaceutical

8. Substance abuse within the past 2 years as it may alter neurotransmitter function

9. Active hematological, renal, pulmonary, endocrine or hepatic disorders

10. Evidence of cortical infarcts or strategically placed lacunar infarct (e.g. dorsal medial nucleus of thalamus)

11. Active cancer, metabolic encephalopathy, infection

12. Active cardiovascular disease, stroke, congestive heart failure

13. Diagnosis of MCI or dementia

Inclusion criteria for healthy volunteers:

1. Male and female, age 18-80

2. Age and gender-matched to PD patients

3. No use of dopaminergic replacement therapy or other medication related to PD

Exclusion criteria for healthy volunteers:

1. Cognitive impairments that may interfere with understanding instructions as needed during the performance of the study (MMSE<23)

2. Subjects who are unable to perform arm reaching movements

3. Self-report of any condition that could affect walking

4. No fractures or skin lesions in the upper or lower limbs

5. Infectious diseases requiring contact precautions

6. Diagnosis of MCI or dementia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Spaulding Rehabilitation Hospital
  • Collaborator
    • Michael J. Fox Foundation for Parkinson’s Research
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paolo Bonato, Principal Investigator – Spaulding Rehabilitation Hospital
  • Overall Official(s)
    • Paolo Bonato, PhD, Principal Investigator, Spaulding Rehabilitation Hospital
  • Overall Contact(s)
    • Eric Fabara, MD, 617-952-6388, efabara@partners.org

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