Brain State-dependent PCMS in Chronic Stroke

NCT04830163 | Not Yet Recruiting Phase 1

• 1 other identifier: STUDY00000896_Exp3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

chronic, movement

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Amplitude of motor evoked potentials

  up to 1 hour after intervention

• Time to complete the 9-hole peg test

  up to 1 hour after intervention

Study Arms (2)

PCMS during brain states reflecting strong corticospinal transmission

EXPERIMENTAL

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

PCMS during random brain states

ACTIVE COMPARATOR

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

Interventions

Brain state-dependent paired corticomotoneuronal stimulation (PCMS) 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.

PCMS during brain states reflecting strong corticospinal transmission; PCMS during random brain states

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Stroke; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2031
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)