Trial Outcomes & Findings for Targeting Personalized Brain States Reflecting Strong and Weak Corticospinal Tract Output in Real-time (NCT NCT06365086)

Last Updated: 2025-04-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

single session

Results posted on

2025-04-17

Participant Flow

There were no specific pre-assignment procedures or events for this study.

Participant milestones

Participant milestones
Measure	Healthy Adults Healthy adults first had single-pulse TMS delivered to the right motor cortex irrespective of ongoing brain activity (i.e., brain states) in order to generate a training dataset that included brain activity recordings and muscle responses to TMS delivery. Then, this training dataset was used to build a personalized mathematical model that discriminated between brain activity patterns reflecting strong and weak corticospinal tract (CST) activation (i.e., strong and weak CST states). After building this model, participants received single-pulse TMS to the right motor cortex during personalized brain states reflecting strong corticospinal tract (CST) activation (strong CST states), weak CST states, and random CST states. Stimulation was delivered at 120% of resting motor threshold and motor-evoked potentials (MEPs) were recorded from the left first dorsal interosseous muscle.
Training Phase STARTED	21
Training Phase COMPLETED	21
Training Phase NOT COMPLETED	0
Testing Phase STARTED	21
Testing Phase Strong CST States	21
Testing Phase Weak CST States	21
Testing Phase Random CST States	21
Testing Phase COMPLETED	21
Testing Phase NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Adults n=19 Participants Healthy adults received single-pulse TMS the right motor cortex during personalized brain states reflecting strong corticospinal tract (CST) activation (strong CST states), weak CST states, and random CST states. Stimulation was delivered at 120% of resting motor threshold and motor-evoked potentials (MEPs) were recorded from the left first dorsal interosseous muscle.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	20.8 years STANDARD_DEVIATION 3.05 • n=99 Participants
Sex: Female, Male Female	15 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	8 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants
Race (NIH/OMB) More than one race	3 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=99 Participants
Region of Enrollment United States	19 Participants n=99 Participants

PRIMARY outcome

Timeframe: single session

Outcome measures

Outcome measures
Measure	Strong CST States n=19 Participants Normalized MEPs elicited during strong CST states were calculated.	Weak CST States n=19 Participants Normalized MEPs elicited during weak CST states were calculated.	Random CST States n=19 Participants Normalized MEPs elicited during random CST states were calculated.
Motor-evoked Potential (MEP) Amplitudes	1.13 arbitrary units (normalized microvolts) Standard Error 0.05	0.96 arbitrary units (normalized microvolts) Standard Error 0.04	0.90 arbitrary units (normalized microvolts) Standard Error 0.05

SECONDARY outcome

Timeframe: single session

An offline version of the real-time EEG analysis algorithm will be used to determine the brain state (i.e., strong or weak CST states, or neither) immediately preceding delivery of each single TMS pulse. The proportion of trials during which the online and offline versions of the real-time EEG analysis algorithm produce the same brain state prediction will be calculated per participant and used as a state-targeting accuracy metric. State-targeting accuracy metrics will be compared to the theoretical chance level (0.5).

Outcome measures

Outcome measures
Measure	Strong CST States n=19 Participants Normalized MEPs elicited during strong CST states were calculated.	Weak CST States n=19 Participants Normalized MEPs elicited during weak CST states were calculated.	Random CST States n=19 Participants Normalized MEPs elicited during random CST states were calculated.
State-targeting Accuracy	94.5 percentage of trials accurately targeted Standard Error 1.1	89.5 percentage of trials accurately targeted Standard Error 2.7	NA percentage of trials accurately targeted Standard Error NA Due to the nature of this condition, the ability of our real-time system to accurately target random CST states cannot be calculated.

Adverse Events

Healthy Adults

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sara Hussain, PhD

University of Texas at Austin

Phone: 5122322686

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place