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Brain State-dependent PCMS in Chronic Stroke

Primary Purpose

Stroke

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Brain state-dependent paired corticomotoneuronal stimulation (PCMS)

About this trial

This is an interventional basic science trial for Stroke focused on measuring chronic, movement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCMS during brain states reflecting strong corticospinal transmission

PCMS during random brain states

Arm Description

Outcomes

Primary Outcome Measures

Maximum hand force output

This will be measured using maximum voluntary contractions of the stroke-affected first dorsal interosseous hand muscle during pinching actions.

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

Secondary Outcome Measures

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 to complete the 9-hole peg test

This will be measured as the time needed to complete the task using the stroke-affected hand.

Full Information

NCT ID

NCT04830163

First Posted

March 31, 2021

Last Updated

December 1, 2022

Sponsor

University of Texas at Austin

1. Study Identification

Unique Protocol Identification Number

NCT04830163

Brief Title

Brain State-dependent PCMS in Chronic Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

chronic, movement

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PCMS during brain states reflecting strong corticospinal transmission

Arm Type

Experimental

Arm Title

PCMS during random brain states

Arm Type

Active Comparator

Intervention Type

Combination Product

Intervention Name(s)

Brain state-dependent paired corticomotoneuronal stimulation (PCMS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maximum hand force output

Description

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

Title

Maximum hand muscle activation

Description

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

Secondary Outcome Measure Information:

Title

Amplitude of motor evoked potentials

Description

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

Title

Time to complete the 9-hole peg test

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Texas at Austin

City

Austin

State/Province

Texas

ZIP/Postal Code

78712

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sara Hussain

Phone

512-232-2686

sara.hussain@austin.utexas.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Individual participant data may be shared using an open-access data repository. No personally-identifiable information will be shared.

Learn more about this trial

Brain State-dependent PCMS in Chronic Stroke

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