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NCT06365099 · ClinicalTrials.gov registry record · Phase 1
Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke
A Phase 1 study of Stroke, sponsored by University of Texas at Austin.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06365099 is a Phase 1 study of Stroke that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 20 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06365099, a Phase 1 study of Stroke, is actively recruiting participants, sponsored by University of Texas at Austin.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 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 do
Conditions Studied
Interventions
- DEVICE Single-pulse TMS
Study Locations (1)
Texas
- University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-02-02 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06365099
The ClinicalTrials.gov registry entry for NCT06365099 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 1 intervention - of which Single-pulse TMS is the first listed.
NCT06365099 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06365099 about?
NCT06365099 is a clinical study titled "Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke". 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 activa...
What is the current status of trial NCT06365099?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-02-02. Estimated completion is 2026-03-31.
What conditions does trial NCT06365099 study?
This clinical trial studies the following conditions: Stroke.
What interventions are being tested in trial NCT06365099?
The interventions under investigation include: Single-pulse TMS (DEVICE).
Who is sponsoring clinical trial NCT06365099?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06365099 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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