Stroke, IschemicNCT05256368
Marker for Stroke Recovery
An observational study of Stroke, Ischemic, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2022to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals poststroke that are inpatients at Shirley Ryan AbilityLab.
Who may be able to join
- 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
Show all 9Show fewer
- Normal hearing and (corrected) vision
- Able to understand and give informed consent
- English speaker
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurophysiological Marker for Predicting Upper Extremity Motor Recovery After Stroke
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.
Read the 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
- Stroke, Ischemic
- Keywords
- Stroke, Motor-evoked potentials (MEPs), Transcranial-Evoked Potentials (TEPs), Task-specific training (TST), Recovery, Markers
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatients poststroke | Individuals post acute or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start30 Jul 2022 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Why it stopped: Insufficient personnel dedication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Pons, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256368
- Sponsor's protocol ID
- STU00214813
- Status last verified
- May 2023
- First submitted
- 21 Sep 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Marker for Predicting Upper Extremity Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT05256368
- Acronym / sponsor ID
- STU00214813
- Conditions
- Stroke, Ischemic
- Keywords
- Stroke, Motor-evoked potentials (MEPs), Transcranial-Evoked Potentials (TEPs), Task-specific training (TST), Recovery, Markers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient personnel dedication.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients poststroke | – | –Individuals post acute or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-80 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals poststroke that are inpatients at Shirley Ryan AbilityLab.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Motor-evoked potentials
Time frame: Baseline, during each visit, and Visit 8 at the 3 month follow-up
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.
Change in Transcranial-evoked potentials
Time frame: Baseline, Visit 4 in the second week, Visit 7 in the third week, and Visit 8 at 3 month follow-up
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.
Changes in Action research arm test scores
Time frame: 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
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motor-evoked potentials (time frame: Baseline, during each visit, and Visit 8 at the 3 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.