A Phase 1/2 interventional study of Brain state-dependent paired corticomotoneuronal stimulation (PCMS) in Stroke, sponsored by University of Texas at Austin. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University of Texas at Austin · Phase 1/2, Interventional, and Basic science
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 45 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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Exclusion Criteria:
Combination Product: Brain state-dependent paired corticomotoneuronal stimulation (PCMS)
Combination Product: Brain state-dependent paired corticomotoneuronal stimulation (PCMS)
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.
Maximum hand force output
This will be measured using maximum voluntary contractions of the stroke-affected first dorsal interosseous hand muscle during pinching actions.
Time frame: up to 1 hour after intervention
Maximum hand muscle activation
This will be measured using electromyography recordings of the stroke-affected first dorsal interosseous muscle during maximum voluntary contractions during pinching actions
Time frame: up to 1 hour after intervention
Amplitude of motor evoked potentials
This will be measured as the peak-to-peak amplitude of motor-evoked potentials recorded from the stroke-affected first dorsal interosseous muscle
Time frame: up to 1 hour after intervention
Time to complete the 9-hole peg test
This will be measured as the time needed to complete the task using the stroke-affected hand.
Time frame: up to 1 hour after intervention
Plan to share: Undecided — Individual participant data may be shared using an open-access data repository. No personally-identifiable information will be shared.
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University of Texas at Austin