Trial Outcomes & Findings for Establishing Functional Biomarkers for Spaced Theta-Burst Stimulation (NCT NCT03687892)
NCT ID: NCT03687892
Last Updated: 2023-11-09
Results Overview
To determine the duration of effect of an application of a spaced TBS stimulation session (both inhibitory, cTBS and excitatory, iTBS) as measured by duration of change in motor evoked potential.
TERMINATED
NA
37 participants
Prior to and and immediately after TBS sessions on each day (separated by 3+ days)
2023-11-09
Participant Flow
Participant milestones
| Measure |
All Participants
Continuous or intermittent Theta Burst Stimulation (iTBS). No participants were randomized to treatment so data are presented in one group.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=22 Participants
Continuous or intermittent Theta Burst Stimulation (iTBS). No participants were randomized to treatment so data are presented in one group.
|
|---|---|
|
Age, Continuous
|
41.77 years
STANDARD_DEVIATION 12.99 • n=22 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Prior to and and immediately after TBS sessions on each day (separated by 3+ days)Population: No outcome measure analysis was possible because no post-baseline data were collected.
To determine the duration of effect of an application of a spaced TBS stimulation session (both inhibitory, cTBS and excitatory, iTBS) as measured by duration of change in motor evoked potential.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to and and immediately after TBS sessions on each day (separated by 3+ days)Population: No outcome measure analysis was possible because no post-baseline data were collected.
To determine the resting state functional connectivity changes that result from an application of spaced TBS stimulations (both inhibitory, cTBS and excitatory, iTBS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to and and immediately after TBS sessions on each day (separated by 3+ days)Population: No outcome measure analysis was possible because no post-baseline data were collected.
To determine the TMS-BOLD (over M1) changes that result from an application of spaced TBS stimulations (both inhibitory, cTBS and excitatory, iTBS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to and and immediately after TBS sessions on each day (separated by 3+ days)Population: No outcome measure analysis was possible because no post-baseline data were collected.
To determine the arterial perfusion changes that result from an application of spaced TBS stimulations (both inhibitory, cTBS and excitatory, iTBS) as measured by ASL.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place