Brain State-dependent PCMS in Chronic Stroke

The University of Texas System (UT)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Stroke

Treatments: Combination Product: Brain state-dependent paired corticomotoneuronal stimulation (PCMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04830163

STUDY00000896_Exp3

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

PCMS during brain states reflecting strong corticospinal transmission

Experimental group

Treatment:

Combination Product: Brain state-dependent paired corticomotoneuronal stimulation (PCMS)

PCMS during random brain states

Active Comparator group

Treatment:

Combination Product: Brain state-dependent paired corticomotoneuronal stimulation (PCMS)