Targeting Personalized Brain States Reflecting Strong and Weak Corticospinal Tract Output in Real-time

NCT06365086 | Completed Results FDA Device

• 1 other identifier: STUDY00000608
• Study Type: interventional
• Target: 21
• 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 hand function after stroke. To maximize the therapeutic effects of such interventions, they must be delivered during poststroke brain activity patterns during which TMS best activates the residual corticospinal tract and enhances neural transmission within it (i.e., brain state-dependent TMS). In this study, the investigators will test the feasibility of real-time, personalized brain state-dependent TMS in neurotypical adults. Participants will visit the laboratory for one day of testing. Upon arrival, participants will provide their informed consent; afterwards, they will complete eligibility screening. The investigators will then place recording electrodes on the scalp using a swim-type cap and on the left first dorsal interosseous, abductor pollicis brevis, and extensor digitorum communis muscles. After determining the location at which TMS best elicits muscle twitches in the left first dorsal interosseous, the investigators will determine the lowest possible intensity at which TMS elicits muscle twitches at least half of the time in this muscle. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while the participant rests quietly with their eyes open; stimulation will be delivered at an intensity that is 20% greater than the lowest possible intensity at which TMS elicits muscle twitches at least half of the time. Afterwards, the investigators will use the muscle and brain activity recordings acquired during these 6 blocks to build a personalized mathematical model that identifies which patterns of brain activity correspond to the largest TMS-evoked muscle twitches. The investigators will then use this model to detect the occurrence of these brain activity patterns in real-time; when these patterns are detected, single TMS pulses will be delivered. Afterwards, all recording electrodes will be removed, participation will be complete, and participants will leave the laboratory. The investigators will recruit a total of 16 neurotypical adults for this study.

Conditions

Neurotypical Adults

Outcome Measures

Primary Outcomes (1)

• Motor-evoked Potential (MEP) Amplitudes

  Peak-to-peak MEP amplitudes elicited by single transcranial magnetic stimulation (TMS) pulses delivered during personalized strong and weak CST states will be measured from the left first dorsal interosseous muscle. 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 compared across CST states.

  single session

Secondary Outcomes (1)

• State-targeting Accuracy

  single session

Interventions

Personalized brain state-dependent single-pulse TMS DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right-hand dominance
• Willingness to participate
• Ability to provide informed consent

You may not qualify if:

• History of major neurological, orthopedic, psychiatric, or cardiovascular disease
• Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including:
• history of adverse reactions to TMS or PNS
• history of stroke or head injury
• metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel,
• surgical clips, fragments from metalworking, fragments from welding
• implanted devices
• 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, including but not limited to: antipsychotic drugs, antidepressants, benzodiazepines, prescription stimulants

Sponsors & Collaborators

• University of Texas at Austin: lead
• Emory University: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Khatri UU, Pulliam K, Manesiya M, Cortez MV, Millan JDR, Hussain SJ. Personalized whole-brain activity patterns predict human corticospinal tract activation in real-time. Brain Stimul. 2025 Jan-Feb;18(1):64-76. doi: 10.1016/j.brs.2024.12.1193. Epub 2024 Dec 21.

  PMID: 39716573 RESULT

Related Links

• Raw data
• Analysis code

Results Point of Contact

• Title: Sara Hussain, PhD
• Organization: University of Texas at Austin

sara.hussain@austin.utexas.edu

5122322686

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive single-pulse TMS during personalized brain activity patterns reflecting either strong or weak corticospinal tract activation

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 15, 2024
• Study Start: January 27, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-03

Locations

US (1)