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

Parkinson Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02896816
• Other study ID #: 2015-P-002526
• Status: Terminated
• Phase: N/A
• Start date: August 2016
• Est. completion date: May 25, 2021

Study information

• Verified date: September 2021
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surface electromyography recording	Surface EMG upper and lower extremities	Baseline
Secondary	Structural MRI	T1 and T2 structural MRI will be performed.	Baseline
Secondary	Functional MRI	Resting state and task functional MRI will be performed to obtain BOLD signals.	Baseline
Secondary	Diffusion weighted imaging	Diffusion weighted imaging will be performed to obtain connectivity measures.	Baseline
Secondary	Altropane PET scan	Altropane PET scan will be performed to assess dopamine transport	Baseline