What this study is
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.
What's being tested
- Brain state-dependent paired corticomotoneuronal stimulation (PCMS)
Intervention · COMBINATION PRODUCT
Paired corticomotoneuronal stimulation (PCMS) involves delivering precisely timed pairs of transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) so that the neuronal activity evoked by such stimulation arrives synchronously at corticospinal-motoneuronal synapses. This synchronous arrival is postulated to cause long-term potentiation via spike timing-dependent plasticity, which then improves corticospinal transmission and hand function. In this study, paired corticomotoneuronal stimulation (PCMS) will be applied during specific brain states that reflect increased recruitment of motoneurons via the corticospinal tract. This increased recruitment is expected to enhance the beneficial effects of PCMS on human hand function after stroke.
Study details
- Official title
- Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation
- Sponsor
- University of Texas at Austin
- Conditions
- Stroke
- Enrolling
- 45 people
- Starts
- 2026-01-01
- Est. completion
- 2031-07
- Design
- Open-label, randomized, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Texas at Austin
Austin, Texas, United States
- Sara Hussain · Contact512-232-2686sara.hussain@austin.utexas.edu
Study team
Sponsor
University of Texas at Austin
Study ID STUDY00000896_Exp3
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.