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

NCT02896816 | Terminated

• 1 other identifier: 2015-P-002526
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson

Keywords

Parkinson's

Outcome Measures

Primary Outcomes (1)

• Surface electromyography recording

  Surface EMG upper and lower extremities

  Baseline

Secondary Outcomes (4)

• Structural MRI

  Baseline

• Functional MRI

  Baseline

• Diffusion weighted imaging

  Baseline

• Altropane PET scan

  Baseline

Study Arms (2)

Parkinson's subjects

EXPERIMENTAL

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

Control subjects

ACTIVE COMPARATOR

Participants not affected by neurological disorders. Surface EMG will be performed at baseline.

Other: Surface EMG

Interventions

Surface EMG, MRI and PET Scan OTHER

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.

Parkinson's subjects

Surface EMG OTHER

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.

Control subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Male and female, age 18-80
• Age and gender-matched to PD patients

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: September 12, 2016
• Study Start: August 1, 2016
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)