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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02896816
Enrollment
17
Registered
2016-09-12
Start date
2016-08-31
Completion date
2021-05-25
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson

Keywords

Parkinson's

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.

Interventions

OTHERSurface 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.

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.

Sponsors

Michael J. Fox Foundation for Parkinson's Research
CollaboratorOTHER
Spaulding Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Surface electromyography recordingBaselineSurface EMG upper and lower extremities

Secondary

MeasureTime frameDescription
Structural MRIBaselineT1 and T2 structural MRI will be performed.
Functional MRIBaselineResting state and task functional MRI will be performed to obtain BOLD signals.
Diffusion weighted imagingBaselineDiffusion weighted imaging will be performed to obtain connectivity measures.
Altropane PET scanBaselineAltropane PET scan will be performed to assess dopamine transport

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026