Trial Outcomes & Findings for Measuring Plasticity in SFC/dACC Following Theta-Burst-Stimulation Using TMS (NCT NCT03946059)

Last Updated: 2021-03-09

Results Overview

Change in superior frontal stimulus-evoked theta oscillations were measure on a set of cognitive tasks, specifically selective attention, response inhibition, working memory, interference processing and emotion processing tasks. The evoked EEG response (mid-frontal theta FCz as a source for superior frontal theta) was averaged across all cognitive tasks to yield a global cognitive task-averaged signal that was measured immediately before (Pre) and immediately after (Post) iTBS, and similarly immediately before (Pre) and immediately after (Post) cTBS.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

(Post-Pre) iTBS and (Post-Pre) cTBS signals were measured one week apart.

Results posted on

2021-03-09

Participant Flow

Participants were screened for this study prior to enrollment. Any individuals with a history of seizure disorder; vascular or other lesion of the brain; administration of drugs that lower the seizure threshold; implanted or non-removable metallic objects above the neck; implanted devices with electrical circuits were excluded from enrollment.

No enrolled participants were excluded.

Participant milestones

Participant milestones
Measure	cTBS Then iTBS Participants received cTBS at week 1 (1 day), washout (1 week) then iTBS at week 2 (1 day). The global cognitive task-average superior frontal theta signal was calculated as (Post - Pre)cTBS versus (Post-Pre)iTBS	iTBS Then cTBS Participants received iTBS at week 1 (1 day), washout (1 week) then cTBS at week 2 (1 day). The global cognitive task-average superior frontal theta signal was calculated as (Post - Pre)iTBS versus (Post-Pre)cTBS
Overall Study STARTED	13	12
Overall Study COMPLETED	13	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measuring Plasticity in SFC/dACC Following Theta-Burst-Stimulation Using TMS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	cTBS Then iTBS n=13 Participants Participants received cTBS at week 1 (1 day), washout (1 week) then iTBS at week 2 (1 day).	iTBS Then cTBS n=12 Participants Participants received iTBS at week 1 (1 day), washout (1 week) then cTBS at week 2 (1 day).	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: (Post-Pre) iTBS and (Post-Pre) cTBS signals were measured one week apart.

Population: Although 25 participants enrolled, only 24 completed the study.

Outcome measures

Outcome measures
Measure	cTBS n=24 Participants Participants received cTBS intervention in one of the two study visits. The global cognitive task-average FCz theta signal was calculated as (Post-Pre)cTBS.	iTBS n=24 Participants The participants received iTBS intervention in one of the two study visits. The global cognitive task-average FCz theta signal was calculated as (Post-Pre)iTBS.
Post vs. Pre Change in Mid-frontal Theta Oscillations for iTBS vs. cTBS Stimulation	-0.043 microVolts (uV) at FCz EEG electrode Standard Deviation 0.17	0.017 microVolts (uV) at FCz EEG electrode Standard Deviation 0.12

SECONDARY outcome

Timeframe: (Post-Pre) iTBS and (Post-Pre) cTBS cognitive performance levels were measured one week apart.

Population: Although 25 participants enrolled, only 24 completed the study.

Change in cognitive performance was measured on a set of cognitive tasks, specifically selective attention, response inhibition, working memory, interference processing and emotion processing tasks. The cognitive performance was averaged across all cognitive tasks to yield global cognitive task-averaged performance that was measured immediately before (Pre) and immediately after (Post) iTBS, and similarly immediately before (Pre) and immediately after (Post) cTBS.

Outcome measures

Outcome measures
Measure	cTBS n=24 Participants Participants received cTBS intervention in one of the two study visits. The global cognitive task-average FCz theta signal was calculated as (Post-Pre)cTBS.	iTBS n=24 Participants The participants received iTBS intervention in one of the two study visits. The global cognitive task-average FCz theta signal was calculated as (Post-Pre)iTBS.
Post vs. Pre Change in Cognitive Performance	0.025 log(1/sec) Standard Deviation 0.027	0.013 log(1/sec) Standard Deviation 0.020

Adverse Events

cTBS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

iTBS

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

Dr. Jyoti Mishra

University of California San Diego

Phone: 8582322855

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place