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Trials / Withdrawn

WithdrawnNCT05256368

Marker for Stroke Recovery

Neurophysiological Marker for Predicting Upper Extremity Motor Recovery After Stroke

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Shirley Ryan AbilityLab · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2022-07-30
Primary completion
2024-08-31
Completion
2024-08-31
First posted
2022-02-25
Last updated
2023-06-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05256368. Inclusion in this directory is not an endorsement.