Marker for Stroke Recovery

NCT05256368 | Withdrawn

• 1 other identifier: STU00214813
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop a neurophysiological marker for post-stroke participants that predicts upper extremity motor recovery in response to a standard upper extremity rehabilitation protocol of task-specific training (TST). For this aim, the researchers will utilize transcranial magnetic stimulation (TMS) combined with electromyography (EMG) and electroencephalography (EEG) to observe inpatients with stroke-related hemiplegia and follow their recovery through outpatient for up to 3 months. Motor-evoked potentials (MEPs), transcranial-evoked potentials (TEPs), action research arm test (ARAT) scores, and clinical outcome measures will be recorded at different time points of the inpatient rehabilitation period. The researchers hypothesize that changes in motor recovery will be reflected in changes in the MEPs and TEPs.

Conditions

Stroke, Ischemic

Keywords

Stroke; Motor-evoked potentials (MEPs); Transcranial-Evoked Potentials (TEPs); Task-specific training (TST); Recovery; Markers

Outcome Measures

Primary Outcomes (3)

• Change in Motor-evoked potentials

  Motor-evoked potentials (MEPs) will be recorded from the right and left EDC muscles, averaged across trials in a visit, and peak-to-peak amplitudes will be measured before vs. after specific-task training in a visit. An increase in MEPs is correlated with motor improvement.

  Baseline, during each visit, and Visit 8 at the 3 month follow-up

• Change in Transcranial-evoked potentials

  Transcranial-evoked potentials (TEPs) will be analyzed in source space to assess changes in brain connectivity. The connectivity changes will be computed before vs. after specific-task training. An increase in connectivity has been correlated with motor improvement.

  Baseline, Visit 4 in the second week, Visit 7 in the third week, and Visit 8 at 3 month follow-up

• Changes in Action research arm test scores

  The Action research arm test (ARAT) will be used to assess changes in motor recovery. The ARAT is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3 (Performs test normally), 2 (Completes test, but takes abnormally long or has great difficulty), 1 (Performs test partially), and 0 (Can perform no part of test). Lyle's decision rules: 1) Patients who achieve a maximum score on the first (most difficult) item are credited with having scored 3 on all subsequent items on that scale, 2) If the patient scores less than 3 on the first item, then the second item is assessed, 3) This is the easiest item, and if patients score 0 then they are unlikely to achieve a score above 0 for the remainder of the items and are credited with a zero for the other items., 4) The maximum score on the ARAT is 57 points (possible range 0 to 57). A higher score usually indicates a better outcome.

  Visit 2 in the first week, Visit 4 in the second week, Visit 6 in the third week, and Visit 8 at 3 month follow-up

Study Arms (1)

Inpatients poststroke

Individuals post acute or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-80

Eligibility Criteria

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

Study Population

Individuals poststroke that are inpatients at Shirley Ryan AbilityLab.

You may qualify if:

• Age from 18 to 80 years
• Stroke (ischemic subcortical, intermediate level, chronic phase one day to 6 weeks or more from lesion)
• Clinical and radiological evidence supporting the above diagnoses
• Chedoke stroke assessment arm stage and hand stage of 3-6 for the affected limb
• One or more behavioral symptoms possibly linked to the white matter lesion(s)
• Stable medical condition
• Normal hearing and (corrected) vision
• Able to understand and give informed consent
• English speaker

You may not qualify if:

• Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
• Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
• Surgical clips in the head or previous neurosurgery
• Any magnetic particles in the body
• Cochlear implants
• Prosthetic heart valves
• Epilepsy or any other type of seizure history
• History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
• Significant other disease (heart disease, malignant tumors, mental disorders)
• Significant claustrophobia; Meniere's disease
• Pregnancy, breast feeding
• Medications increasing risk for seizures
• Non prescribed drug use
• Failure to perform the behavioral tasks or neuropsychological evaluation tests
• Prisoners

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: February 25, 2022
• Study Start: July 30, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

US (1)