RECRUITING

Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke

Quick Facts

Study Start:2024-02-02
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06365099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of stroke \>6 months ago
  2. * Presence of residual upper extremity hemiparesis
  3. * Willingness to participate
  4. * Ability to provide informed consent
  5. * Upper extremity Fugl-Meyer score \< 66
  6. * Mini Mental State Exam score \> 24
  7. * Discernable and reliable motor-evoked potential (MEP) following single-pulse transcranial magnetic stimulation to the lesioned hemisphere
  1. * History of neurological disease and/or neurological injury other than stroke
  2. * Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS) including:
  3. * cardiac pacemaker, cochlear implant, cortical stimulator, deep brain stimulator, vagus nerve stimulator, cervical spine epidural stimulator, and/or ventriculoperitoneal shunt
  4. * ferromagnetic metallic implants above the level of the seventh cervical vertebrae
  5. * seizure in the last 12 months while taking anti-epilepsy medication
  6. * history of adverse reactions to TMS or PNS
  7. * current, suspected, or planned pregnancy
  8. * recent changes (within the last month) to medication use
  9. * Upper extremity Fugl-Meyer score = 66
  10. * Mini Mental State Exam score \<= 24
  11. * No discernible or reliable MEP elicited following single-pulse TMS to the lesioned hemisphere

Contacts and Locations

Study Locations (Sites)

University of Texas at Austin
Austin, Texas, 78712
United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-02
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-02-02
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Stroke