Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06365099

Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke

Led by University of Texas at Austin · Updated on 2025-02-10

20

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

Sponsors

U

University of Texas at Austin

Lead Sponsor

E

Emory University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 framework's 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.

CONDITIONS

Official Title

Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of residual upper extremity weakness defined by any of the following: Fugl-Meyer Upper Extremity Score less than 66, Wolf Motor Function Test Score less than 70, affected hand 9-Hole Peg Test performance at least 10% worse than unaffected hand, or affected hand grip performance at least 10% worse than unaffected hand
  • Stroke (ischemic or hemorrhagic) occurred at least 6 months before participation
  • Willingness and ability to provide informed consent
  • Presence of residual corticospinal connections to an affected upper extremity muscle as shown by muscle response to brain stimulation
Not Eligible

You will not qualify if you...

  • History of neurological disease or injury other than stroke
  • Contraindications to TMS including cardiac pacemaker, cochlear implant, cortical stimulator, deep brain stimulator, vagus nerve stimulator, cervical spine epidural stimulation, ventriculoperitoneal shunt, or ferromagnetic metallic implants above the seventh cervical vertebra
  • Seizure in the last 12 months while taking anti-epilepsy medication
  • History of adverse reactions to TMS or peripheral nerve stimulation
  • Current, suspected, or planned pregnancy
  • Recent medication changes within the last month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Texas at Austin

Austin, Texas, United States, 78712

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NA

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

0

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Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke | DecenTrialz