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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Active, not recruiting
Phase 1

Conditions

Neurotypical Adults

Treatments

Device: Personalized brain state-dependent single-pulse TMS

Study type

Interventional

Funder types

Other

Identifiers

NCT06365086
STUDY00000608

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Crossover Assignment

Masking

Double Blind

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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