Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365099
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-05
Brief Title:
Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transcranial magnetic stimulation TMS interventions could feasibly strengthen residual corticospinal tract CST connections and promote poststroke hand motor recovery To maximize the effects of such interventions they must be delivered during brain activity patterns during which TMS best activates the residual CST and enhances its neural transmission This approach is termed brain state-dependent TMS The investigators have recently developed a machine learning framework that identifies personalized brain activity patterns reflecting strong CST activation in neurotypical adults In this study the investigators will apply this framework to the poststroke brain for the first time They will also evaluate relationships between this frameworks ability to detect strong and weak CST activation states and measures of CST pathway integrity
Participants will visit the laboratory for two days of testing that are separated by at least one night of sleep On Day 1 participants will provide their informed consent The MacArthur Competence Assessment Tool and the Frenchay Aphasia Screening Test will be used to evaluate consent capacity and confirm the presence of expressive aphasia as needed Afterwards participants will complete eligibility screening and clinical assessment of upper extremity motor impairment motor function and disability using the Upper Extremity Fugl-Meyer Assessment the Wolf Motor Function Test and the Modified Rankin Scale Participants will then be screened for the presence of residual CST connections from the lesioned hemisphere to the affected first dorsal interosseous muscle Recording electrodes will be attached to this muscle in order to record TMS-evoked twitches in these muscles During this procedure single-pulse TMS will be applied to each point of a 1 cm resolution grid covering primary and secondary motor areas of the lesioned hemisphere at maximum stimulator output If TMS reliably elicits a muscle twitch in the affected first dorsal interosseous that participant will be considered to have residual CST connections and will be eligible for the full study If no muscle twitch is observed the participant will not be eligible for the full study Afterwards recording electrodes will be removed and the participant will leave the laboratory
On Day 2 participants will return to the laboratory The investigators will confirm continued eligibility and place recording electrodes on the scalp using a swim-type cap The investigators will also place recording electrodes on the affected first dorsal interosseous as well as the affected abductor pollicis brevis and extensor digitorum communis muscles After identifying the scalp location at which TMS best elicits muscle twitches in the affected first dorsal interosseous muscle the investigators will determine the lowest possible TMS intensity that such evokes muscle twitches at least half of the time Then the investigators will deliver 6 blocks of 100 single TMS pulses while participants rest quietly with their eyes open Stimulation will be delivered at an intensity that is 20 greater than the lowest possible TMS intensity that evokes muscle twitches at least half the time Afterwards all electrodes will be removed participation will be complete and participants will leave the laboratory
The investigators will recruit a total of 20 chronic stroke survivors for this study
Participants will visit the laboratory for two days of testing that are separated by at least one night of sleep On Day 1 participants will provide their informed consent The MacArthur Competence Assessment Tool and the Frenchay Aphasia Screening Test will be used to evaluate consent capacity and confirm the presence of expressive aphasia as needed Afterwards participants will complete eligibility screening and clinical assessment of upper extremity motor impairment motor function and disability using the Upper Extremity Fugl-Meyer Assessment the Wolf Motor Function Test and the Modified Rankin Scale Participants will then be screened for the presence of residual CST connections from the lesioned hemisphere to the affected first dorsal interosseous muscle Recording electrodes will be attached to this muscle in order to record TMS-evoked twitches in these muscles During this procedure single-pulse TMS will be applied to each point of a 1 cm resolution grid covering primary and secondary motor areas of the lesioned hemisphere at maximum stimulator output If TMS reliably elicits a muscle twitch in the affected first dorsal interosseous that participant will be considered to have residual CST connections and will be eligible for the full study If no muscle twitch is observed the participant will not be eligible for the full study Afterwards recording electrodes will be removed and the participant will leave the laboratory
On Day 2 participants will return to the laboratory The investigators will confirm continued eligibility and place recording electrodes on the scalp using a swim-type cap The investigators will also place recording electrodes on the affected first dorsal interosseous as well as the affected abductor pollicis brevis and extensor digitorum communis muscles After identifying the scalp location at which TMS best elicits muscle twitches in the affected first dorsal interosseous muscle the investigators will determine the lowest possible TMS intensity that such evokes muscle twitches at least half of the time Then the investigators will deliver 6 blocks of 100 single TMS pulses while participants rest quietly with their eyes open Stimulation will be delivered at an intensity that is 20 greater than the lowest possible TMS intensity that evokes muscle twitches at least half the time Afterwards all electrodes will be removed participation will be complete and participants will leave the laboratory
The investigators will recruit a total of 20 chronic stroke survivors for this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None