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

NCT ID: NCT06365086

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-27
• Study Completion Date: 2025-01-01

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

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Interventions

Personalized brain state-dependent single-pulse TMS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas at Austin

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 39716573 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://openneuro.org/datasets/ds005779/versions/1.0.1

Raw data

https://github.com/SMNPLab/Realtime_decoding_neurotypical.git

Analysis code

Other Identifiers

STUDY00000608

Identifier Type: -

Identifier Source: org_study_id