Clinical trial NCT02896816: 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
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson
Keywords: Parkinson's
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2016-09-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Surface electromyography recording
timeFrame: Baseline
Secondary outcomes:
measure: Structural MRI
timeFrame: Baseline
measure: Functional MRI
timeFrame: Baseline
measure: Diffusion weighted imaging
timeFrame: Baseline
measure: Altropane PET scan
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: