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

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ClinicalTrials.gov Identifier: NCT02896816
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Paolo Bonato, 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.


Condition or disease Intervention/treatment Phase
Parkinson Other: Surface EMG, MRI and PET Scan Other: Surface EMG Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : August 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Surface electromyography recording [ Time Frame: Baseline ]
    Surface EMG upper and lower extremities


Secondary Outcome Measures :
  1. Structural MRI [ Time Frame: Baseline ]
    T1 and T2 structural MRI will be performed.

  2. Functional MRI [ Time Frame: Baseline ]
    Resting state and task functional MRI will be performed to obtain BOLD signals.

  3. Diffusion weighted imaging [ Time Frame: Baseline ]
    Diffusion weighted imaging will be performed to obtain connectivity measures.

  4. Altropane PET scan [ Time Frame: Baseline ]
    Altropane PET scan will be performed to assess dopamine transport



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896816


Contacts
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Contact: Eric Fabara, MD 617-952-6388 efabara@partners.org
Contact: Catherine Adans-Dester, PT 617-952-6321 cadans-dester@partners.org

Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Jean-Francois Daneault, PhD    617-952-6331    jdaneault@partners.org   
Contact: Catherine Adans-Dester, PT    617-952-6321    cadans-dester@partners.org   
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Michael J. Fox Foundation for Parkinson's Research
Investigators
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Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital

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Responsible Party: Paolo Bonato, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02896816     History of Changes
Other Study ID Numbers: 2015-P-002526
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paolo Bonato, Spaulding Rehabilitation Hospital:
Parkinson's

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases