Real-time Personalized Brain State-dependent TMS After Stroke

NCT06533176 | Recruiting

• 2 other identifiers: 202504299R03HD114188
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and enhance recovery of paretic upper extremity function after stroke. This project will test whether personalized brain state-dependent TMS can activate the residual corticospinal tract better than standard TMS, and evaluate the relationship between this activation and upper extremity motor impairment.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• MEP amplitudes

  Peak-to-peak MEP amplitudes elicited by single TMS pulses delivered during personalized brain activity patterns corresponding to strong corticospinal transmission and random brain activity patterns will be measured. At the individual participant level, all MEP amplitudes will be normalized to the mean MEP amplitude observed in that participant. Mean normalized MEP amplitudes will be used to calculate the percentage MEP amplitude difference between the two brain activity patterns (i.e., strong and random).

  1 week

• Upper Extremity Fugl-Meyer Assessment Scores

  Scores obtained for each participant during the Upper Extremity Fugl-Meyer Assessment will be calculated. This will provide a single impairment score that will be correlated with the percentage MEP amplitude difference between brain activity patterns reflecting strong corticospinal transmission and random brain activity patterns.

  1 week

Study Arms (2)

Brain state-dependent TMS during strong states

EXPERIMENTAL

Device: Personalized brain state-dependent single-pulse TMS

Brain state-dependent TMS during random states

ACTIVE COMPARATOR

Device: Personalized brain state-dependent single-pulse TMS

Interventions

Personalized brain state-dependent single-pulse TMS DEVICE

Single-pulse TMS will be applied to the lesioned hemisphere during brain activity patterns associated with strong residual corticospinal tract activation and random brain activity patterns.

Brain state-dependent TMS during random states; Brain state-dependent TMS during strong states

Eligibility Criteria

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

-Presence of residual upper extremity hemiparesis, defined as any of the following: Fugl Meyer Upper Extremity Score \<66, Wolf Motor Function Test Score \<70, Affected hand performance on the 9-Hole Peg Test \>= 10% worse than unaffected hand, Affected hand pinch, key, or power grip performance \>= 10% worse than unaffected hand, * Occurrence of ischemic or hemorrhagic stroke \>= 6 months before participation * Mini Mental State Exam score \> 24 * Willingness and ability to provide informed consent * No history of neurological disease and/or neurological injury other than stroke * No TMS contraindications, including but not limited to: Cardiac pacemaker, Cochlear implant, Cortical stimulator, Deep brain stimulator, Vagus nerve stimulator, Cervical spine epidural stimulation, Ventriculoperitoneal shunt, Ferromagnetic metallic implants above the level of the seventh cervical vertebra, Seizure in the last 12 months while taking anti-epilepsy medication, History of adverse reactions to TMS or peripheral nerve stimulation, Current, suspected, or planned pregnancy, Any recent changes (within the last month) to medication use \- Presence of residual corticospinal connections innervating an affected upper extremity muscle following stimulation of the lesioned hemisphere (i.e., MEP+), evaluated at rest

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sara Hussain: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sara J Hussain, PhD

CONTACT

319-335-1182; sara-hussain@uiowa.edu

Sara J Hussain, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)