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

NCT ID: NCT02896816

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2021-05-25

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.

Conditions

Parkinson

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Parkinson's subjects

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.

Group Type: EXPERIMENTAL

Surface EMG, MRI and PET Scan

Intervention Type: 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.

Control subjects

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

Group Type: ACTIVE_COMPARATOR

Surface EMG

Intervention Type: 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.

Interventions

Surface 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.

Intervention Type: OTHER

Surface EMG

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paolo Bonato

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Bonato, PhD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2015-P-002526

Identifier Type: -

Identifier Source: org_study_id