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



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:4/6/2019
Start Date:August 2016
End Date:December 2019
Contact:Eric Fabara, MD
Email:efabara@partners.org
Phone:617-952-6388

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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.

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.

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
We found this trial at
1
site
300 1st Avenue
Boston, Massachusetts 02129
617-952-5000
Phone: 617-952-6331
Spaulding Rehabilitation Hospital At Spaulding Rehabiliation Hospital Boston, our unique approach to therapy includes use...
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Boston, MA
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