Brain State-dependent PCMS in Chronic Stroke

Stroke Clinical Trial

Official title:

Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830163
• Other study ID #: STUDY00000896_Exp3
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2022
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum hand force output	This will be measured using maximum voluntary contractions of the stroke-affected first dorsal interosseous hand muscle during pinching actions.	up to 1 hour after intervention
Primary	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	up to 1 hour after intervention
Secondary	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	up to 1 hour after intervention
Secondary	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.	up to 1 hour after intervention