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Brain State-dependent PCMS in Chronic Stroke

NCT ID: NCT04830163

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2031-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Keywords

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chronic, movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PCMS during brain states reflecting strong corticospinal transmission

Group Type EXPERIMENTAL

Brain state-dependent paired corticomotoneuronal stimulation (PCMS)

Intervention Type 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 random brain states

Group Type ACTIVE_COMPARATOR

Brain state-dependent paired corticomotoneuronal stimulation (PCMS)

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

Facility Contacts

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Sara Hussain

Role: primary

Other Identifiers

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STUDY00000896_Exp3

Identifier Type: -

Identifier Source: org_study_id