Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke

Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke (NCT06365099) is a Phase 1 interventional studying Stroke, sponsored by University of Texas at Austin. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Stroke, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

* Presence of residual upper extremity hemiparesis, defined as any of the following Fugl Meyer Upper Extremity Score \<66 Wolf Motor Function Test Score \<70 Affected hand performance on the 9-Hole Peg Test \>= 10% worse than unaffected hand Affected hand pinch, key, or power grip performance \>= 10% worse than unaffected hand - Occurrence of ischemic or hemorrhagic stroke \>= 6 months before participation - Willingness and ability to provide willing to sign a consent form - No history of neurological disease and/or neurological injury other than stroke - No TMS contraindications, including but not limited to: Cardiac pacemaker Cochlear implant Cortical stimulator Deep brain stimulator Vagus nerve stimulator Cervical spine epidural stimulation Ventriculoperitoneal shunt Ferromagnetic metallic implants above the level of 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 Any recent changes (within the last month) to medication use \- Presence of residual corticospinal connections innervating an affected upper extremity muscle following stimulation of the lesioned hemisphere (i.e., MEP+), evaluated at rest Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

* Presence of residual upper extremity hemiparesis, defined as any of the following Fugl Meyer Upper Extremity Score \<66 Wolf Motor Function Test Score \<70 Affected hand performance on the 9-Hole Peg Test \>= 10% worse than unaffected hand Affected hand pinch, key, or power grip performance \>= 10% worse than unaffected hand * Occurrence of ischemic or hemorrhagic stroke \>= 6 months before participation * Willingness and ability to provide informed consent * No history of neurological disease and/or neurological injury other than stroke * No TMS contraindications, including but not limited to: Cardiac pacemaker Cochlear implant Cortical stimulator Deep brain stimulator Vagus nerve stimulator Cervical spine epidural stimulation Ventriculoperitoneal shunt Ferromagnetic metallic implants above the level of 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 Any recent changes (within the last month) to medication use \- Presence of residual corticospinal connections innervating an affected upper extremity muscle following stimulation of the lesioned hemisphere (i.e., MEP+), evaluated at rest

Treatments Being Tested

DEVICE

Single-pulse TMS

Single-pulse TMS will be applied to the lesioned hemisphere while participants rest quietly with their eyes open

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Texas at Austin

Austin, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06365099), the sponsor (University of Texas at Austin), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06365099 clinical trial studying?

Who can participate in NCT06365099?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06365099?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06365099. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06365099. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.