EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson's Disease
Primary Purpose
Parkinson
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surface EMG, MRI and PET Scan
Surface EMG
Sponsored by
About this trial
This is an interventional screening trial for Parkinson focused on measuring Parkinson's
Eligibility Criteria
Inclusion Criteria for Parkinson's volunteers:
- Male and female, age 18-80
- Motor symptoms only on one side of the body
- No use of dopaminergic replacement therapy or other medication related to PD
Exclusion Criteria for Parkinson's volunteers:
- Cognitive impairments that may interfere with understanding instructions as needed during the performance of the study (MMSE<23)
- Subjects who are unable to perform arm reaching movements
- Self-report of any condition that could affect walking
- No fractures or skin lesions in the upper or lower limbs
- Infectious diseases requiring contact precautions
- 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)
- 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
- Substance abuse within the past 2 years as it may alter neurotransmitter function
- Active hematological, renal, pulmonary, endocrine or hepatic disorders
- Evidence of cortical infarcts or strategically placed lacunar infarct (e.g. dorsal medial nucleus of thalamus)
- Active cancer, metabolic encephalopathy, infection
- Active cardiovascular disease, stroke, congestive heart failure
- Diagnosis of MCI or dementia
Inclusion criteria for healthy volunteers:
- Male and female, age 18-80
- Age and gender-matched to PD patients
- No use of dopaminergic replacement therapy or other medication related to PD
Exclusion criteria for healthy volunteers:
- Cognitive impairments that may interfere with understanding instructions as needed during the performance of the study (MMSE<23)
- Subjects who are unable to perform arm reaching movements
- Self-report of any condition that could affect walking
- No fractures or skin lesions in the upper or lower limbs
- Infectious diseases requiring contact precautions
- Diagnosis of MCI or dementia
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parkinson's subjects
Control subjects
Arm Description
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.
Participants not affected by neurological disorders. Surface EMG will be performed at baseline.
Outcomes
Primary Outcome Measures
Surface electromyography recording
Surface EMG upper and lower extremities
Secondary Outcome Measures
Structural MRI
T1 and T2 structural MRI will be performed.
Functional MRI
Resting state and task functional MRI will be performed to obtain BOLD signals.
Diffusion weighted imaging
Diffusion weighted imaging will be performed to obtain connectivity measures.
Altropane PET scan
Altropane PET scan will be performed to assess dopamine transport
Full Information
NCT ID
NCT02896816
First Posted
June 29, 2016
Last Updated
September 27, 2021
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Michael J. Fox Foundation for Parkinson's Research
1. Study Identification
Unique Protocol Identification Number
NCT02896816
Brief Title
EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson's Disease
Official Title
EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
No more funding
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Michael J. Fox Foundation for Parkinson's Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson
Keywords
Parkinson's
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's subjects
Arm Type
Experimental
Arm Description
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.
Arm Title
Control subjects
Arm Type
Active Comparator
Arm Description
Participants not affected by neurological disorders. Surface EMG will be performed at baseline.
Intervention Type
Other
Intervention Name(s)
Surface EMG, MRI and PET Scan
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Surface EMG
Intervention Description
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 Measure Information:
Title
Surface electromyography recording
Description
Surface EMG upper and lower extremities
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Structural MRI
Description
T1 and T2 structural MRI will be performed.
Time Frame
Baseline
Title
Functional MRI
Description
Resting state and task functional MRI will be performed to obtain BOLD signals.
Time Frame
Baseline
Title
Diffusion weighted imaging
Description
Diffusion weighted imaging will be performed to obtain connectivity measures.
Time Frame
Baseline
Title
Altropane PET scan
Description
Altropane PET scan will be performed to assess dopamine transport
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Parkinson's volunteers:
Male and female, age 18-80
Motor symptoms only on one side of the body
No use of dopaminergic replacement therapy or other medication related to PD
Exclusion Criteria for Parkinson's volunteers:
Cognitive impairments that may interfere with understanding instructions as needed during the performance of the study (MMSE<23)
Subjects who are unable to perform arm reaching movements
Self-report of any condition that could affect walking
No fractures or skin lesions in the upper or lower limbs
Infectious diseases requiring contact precautions
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)
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
Substance abuse within the past 2 years as it may alter neurotransmitter function
Active hematological, renal, pulmonary, endocrine or hepatic disorders
Evidence of cortical infarcts or strategically placed lacunar infarct (e.g. dorsal medial nucleus of thalamus)
Active cancer, metabolic encephalopathy, infection
Active cardiovascular disease, stroke, congestive heart failure
Diagnosis of MCI or dementia
Inclusion criteria for healthy volunteers:
Male and female, age 18-80
Age and gender-matched to PD patients
No use of dopaminergic replacement therapy or other medication related to PD
Exclusion criteria for healthy volunteers:
Cognitive impairments that may interfere with understanding instructions as needed during the performance of the study (MMSE<23)
Subjects who are unable to perform arm reaching movements
Self-report of any condition that could affect walking
No fractures or skin lesions in the upper or lower limbs
Infectious diseases requiring contact precautions
Diagnosis of MCI or dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Bonato, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson's Disease
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