NCT04830163Not yet recruitingPhase 1/2
Brain State-dependent PCMS in Chronic Stroke
Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
After stroke, people often have difficulty using their hands. Combined brain and nerve stimulation can strengthen the neural pathways that control hand function. In this study, we will deliver combined brain and nerve stimulation during specific time windows that increase activation of neural pathways underlying hand function. We will compare the effects of combined brain and nerve stimulation during these optimal time windows to the effects of combined brain and nerve stimulation applied during random time windows on post-stroke hand function.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 31 Mar 2021
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Jul 2030
- Lead sponsor
- University of Texas at Austin
- Diseases
- Stroke
- NCT number
- NCT04830163
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 45
- From 1 Jan 2026 to the primary completion date, 31 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of neurological disease other than stroke
- Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including: history of adverse reactions to TMS or PNS metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel, surgical clips, fragments from metalworking, fragments from welding, implanted device, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system other than selective serotonin reuptake inhibitors (SSRIs), including but not limited to antipsychotic drugs, benzodiazepines, prescription stimulants.
Other
- Upper extremity Fugl-Meyer score ≥ 66 (66 is the maximum on this scale)
- Mini Mental State Exam score \<= 24
- No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere
Who the study is looking for
- History of stroke \> 6 months ago
- Presence of residual upper extremity hemiparesis
- Willingness to participate
- Ability to provide informed consent
- Upper extremity Fugl-Meyer score \< 66
- Mini Mental State Exam score \> 24
- Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas at Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.