The Influence of Exercise on Neuroplasticity and Motor Learning After Stroke

Stroke Clinical Trial

— EX-ML3  

Official title:

The Influence of Acute Bouts of Aerobic Exercise on Neuroplasticity and Motor Learning After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02980796
• Other study ID #: H16-01945
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2016
• Last updated: August 11, 2017
• Start date: November 2016
• Est. completion date: August 2022

Study information

• Verified date: August 2017
• Source: University of British Columbia
• Contact: Asha Toner, BSc
• Phone: 604-828-6303
• Email: asha.toner[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants will complete 11 sessions. These include screening, 5 sessions where exercise or rest (according to group assignment) are paired with practice of a motor task, MRI and Transcranial Magnetic Stimulation (TMS) before and after the intervention will be used to assess neuroplasticity (ability for the brain to reorganize and create new connections).

Description:

All participants will complete baseline sessions: 1) sub-maximal exercise test to ensure safe participation in aerobic exercise (testing session [s] 1); and 2) magnetic resonance imaging (MRI) to assess brain structure and function, and 3) clinical assessments of motor function and activity. The MRI and clinical tests will be completed on s2. Between the exercise test and MRI sessions individuals will wear accelerometers for 3 days to index usual activity levels. A custom computer program will then assign participants quasi-randomly to either the rest or exercise groups stratified on age, sex, and baseline motor function. Cortical excitability will be assessed before and after either a single session of priming aerobic exercise, or rest, by group (s3). Next, priming exercise will be paired with skilled motor practice for 5 sessions (s4-8). Practice sessions will be separated by 48 hours. Importantly motor learning will be assessed via delayed, no-exercise retention tests 24-hours (s9) and 30-days (s11) after the last practice session. Activity levels (3 day accelerometry), TMS and MRI measures will be re-assessed after the second retention test (s10).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: August 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Between the ages of 40 - 85

• Had a stroke at least 12 months ago

• OR are a healthy adult who does not have a history of neurodegenerative disorders

• Have the ability to understand English

Exclusion Criteria:

• Contraindication to brain stimulation (such as a history of seizure or epilepsy)

• Contraindication to MRI (such as a pacemaker, metal in the eyes / brain or fear of enclosed spaces)

• Neurodegenerative disorder ( such as Parkinson disease, Alzheimers disease or Multiple Sclerosis)

• Contraindications to exercise

Related Conditions & MeSH terms

• Exercise
• Rest
• Stroke

Intervention

Behavioral:
• Exercise
Each experimental day participants will complete an acute bout of exercise on a recumbent bike.
• Practice
Each experimental day participants will complete a session of skilled motor practice.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change response time during a novel motor task.	Serial targeting task	Baseline, After Intervention (2 weeks), 30-day follow-up
Primary	Wolf Motor Function Task Rate	Standardized test of arm motor function	Baseline, After Intervention (2 weeks), 30-day follow-up
Secondary	Transcallosal Inhibition	Ipsilateral silent period	Baseline, After Intervention (2 weeks), 30-day follow-up
Secondary	Arm Use Ratio	Accelerometry	Baseline, After Intervention (2 weeks), 30-day follow-up
Secondary	Functional magnetic resonance imaging (fMRI)	Resting state fMRI	Baseline, After Intervention (2 weeks), 30-day follow-up
Secondary	Structural magnetic resonance imaging - myelin	Myelin water fraction	Baseline, After Intervention (2 weeks), 30-day follow-up
Secondary	Structural magnetic resonance imaging - diffusion	Diffusion weighted fractional anisotrophy	Baseline, After Intervention (2 weeks), 30-day follow-up