Clinical trial NCT05256368: Marker for Stroke Recovery
Official title: Neurophysiological Marker for Predicting Upper Extremity Motor Recovery After Stroke
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke, Ischemic
Keywords: Stroke
Motor-evoked potentials (MEPs)
Transcranial-Evoked Potentials (TEPs)
Task-specific training (TST)
Recovery
Markers
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals poststroke that are inpatients at Shirley Ryan AbilityLab.

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.

Detailed description: 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), and clinical outcome measures. The researchers will enroll inpatients with stroke-related hemiplegia with a variety of severities (based on the Chedoke-McMaster arm and hand stage) and follow their recovery through outpatient for up to 3 months. Motor-evoked potentials (MEPs), transcranial-evoked potentials (TEPs), and action research arm test (ARAT) scores 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. Therefore, the researchers will correlate these novel physiological measures with the ARAT scores to develop a neurophysiological marker to predict upper extremity motor recovery. Aim 1 investigates short-term and long-term changes in MEPs before vs. after rehabilitation. Aim 2 focuses on studying brain connectivity changes before vs. after rehabilitation. Aim 3 assesses the ARAT scores. Aim 4 correlates the results obtained from Aims 1-3 (i.e., MEPs, brain connectivity, and the ARAT scores) and uses advanced statistical methods and machine learning algorithms to develop an objective and accurate predictor of upper extremity motor recovery.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Motor-evoked potentials
timeFrame: Baseline, during each visit, and Visit 8 at the 3 month follow-up
measure: Change in Transcranial-evoked potentials
timeFrame: Baseline, Visit 4 in the second week, Visit 7 in the third week, and Visit 8 at 3 month follow-up
measure: Changes in Action research arm test scores
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References: