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

Sponsor
Spaulding Rehabilitation Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT02896816
Collaborator
Michael J. Fox Foundation for Parkinson's Research (Other)
17
Enrollment
1
Location
2
Arms
57.8
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Surface EMG, MRI and PET Scan
  • Other: Surface EMG
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson's Disease
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
May 25, 2021
Actual Study Completion Date :
May 25, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

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.
Active Comparator: Control subjects

Participants not affected by neurological disorders. Surface EMG will be performed at baseline.

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.

Outcome Measures

Primary Outcome Measures

  1. Surface electromyography recording [Baseline]

    Surface EMG upper and lower extremities

Secondary Outcome Measures

  1. Structural MRI [Baseline]

    T1 and T2 structural MRI will be performed.

  2. Functional MRI [Baseline]

    Resting state and task functional MRI will be performed to obtain BOLD signals.

  3. Diffusion weighted imaging [Baseline]

    Diffusion weighted imaging will be performed to obtain connectivity measures.

  4. Altropane PET scan [Baseline]

    Altropane PET scan will be performed to assess dopamine transport

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Spaulding Rehabilitation Hospital Boston Massachusetts United States 02129

Sponsors and Collaborators

  • Spaulding Rehabilitation Hospital
  • Michael J. Fox Foundation for Parkinson's Research

Investigators

  • Principal Investigator: Paolo Bonato, PhD, Spaulding Rehabilitation Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Bonato, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT02896816
Other Study ID Numbers:
  • 2015-P-002526
First Posted:
Sep 12, 2016
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Paolo Bonato, Principal Investigator, Spaulding Rehabilitation Hospital
Parkinson's
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Oct 4, 2021