Trial Outcomes & Findings for Regulating Homeostatic Plasticity and the Physiological Response to rTMS (NCT NCT03309696)
NCT ID: NCT03309696
Last Updated: 2020-11-17
Results Overview
TEPs refer to TMS-evoked EEG potentials. The P100 amplitude of TEPs is one means of assessing cortical excitability. The P100 amplitude has been shown to be a reliable metric in studies of healthy subjects. The P100 amplitude is used in this study to assess the excitation state of two regions of interest (ROIs), one in the TC and one in the DLPFC, at each period of TEP recording (i.e., Baseline, Post tDCS, Post rTMS, and 20 minute delay).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Up to 8 weeks
Results posted on
2020-11-17
Participant Flow
Participant milestones
| Measure |
tDCS and 1 Hz rTMS Delivered Over TC
Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC. .
sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.
sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active
active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active
|
tDCS Over DLFC and 1 Hz rTMS Over TC
Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.
sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.
sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active
active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active
|
tDCS and 10Hz rTMS Delivered Over TC
Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.
sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.
sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active
active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active
|
tDCS Over DLFC and 10 Hz rTMS Over TC
Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.
sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.
sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active
active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
tDCS and 1 Hz rTMS Delivered Over TC
Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC. .
sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.
sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active
active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active
|
tDCS Over DLFC and 1 Hz rTMS Over TC
Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.
sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.
sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active
active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active
|
tDCS and 10Hz rTMS Delivered Over TC
Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.
sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.
sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active
active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active
|
tDCS Over DLFC and 10 Hz rTMS Over TC
Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.
sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.
sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active
active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active
|
|---|---|---|---|---|
|
Overall Study
Analysis of TEP data could not be completed
|
0
|
5
|
0
|
0
|
Baseline Characteristics
Outcome measures are not reported for the DLPF arm because, due to insufficient resources and the required personnel needed to perform the data cleaning and pipeline analysis, no P100 amplitude data can be reported.
Baseline characteristics by cohort
| Measure |
tDCS and 1 Hz rTMS Delivered Over TC
n=5 Participants
Baseline characteristics for participants assigned to the arm that received tDCS and 1Hz rTMS over the temporal cortex.
|
tDCS and 1 Hz rTMS Delivered Over DLPF
n=5 Participants
Baseline characteristics for participants assigned to the arm that received tDCS and 1Hz rTMS over the dorsolateral frontal cortex.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
32 years
STANDARD_DEVIATION 15.14 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 14.16 • n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
|
Mean baseline P100 amplitude of the GMFA
|
1.29 µV
STANDARD_DEVIATION 0.47 • n=5 Participants • Outcome measures are not reported for the DLPF arm because, due to insufficient resources and the required personnel needed to perform the data cleaning and pipeline analysis, no P100 amplitude data can be reported.
|
—
|
1.29 µV
STANDARD_DEVIATION 0.47 • n=5 Participants • Outcome measures are not reported for the DLPF arm because, due to insufficient resources and the required personnel needed to perform the data cleaning and pipeline analysis, no P100 amplitude data can be reported.
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: The analyses population is 5 subjects who were assigned to the arm "tDCS and 1 Hz rTMS over the temporal cortex". The group titles reflect sequences of sham and active tDCS and rTMS conditions used to create contrasts for data analysis. Outcome measures are not reported for the DLPF arm because, due to insufficient resources and the required personnel needed to perform the extensive data cleaning and pipeline analysis, no P100 amplitude data can be reported.
TEPs refer to TMS-evoked EEG potentials. The P100 amplitude of TEPs is one means of assessing cortical excitability. The P100 amplitude has been shown to be a reliable metric in studies of healthy subjects. The P100 amplitude is used in this study to assess the excitation state of two regions of interest (ROIs), one in the TC and one in the DLPFC, at each period of TEP recording (i.e., Baseline, Post tDCS, Post rTMS, and 20 minute delay).
Outcome measures
| Measure |
Sham tDCS Preconditioning
n=5 Participants
TEPs recorded post sham tDCS but before rTMS.
|
Active tDCS Preconditioning
n=5 Participants
TEPs recorded after active tDCS preconditioning but before rTMS.
|
Sham tDCS Preconditioning of Sham rTMS
n=5 Participants
TEPs recorded after sham tDCS preconditioning and sham rTMS.
|
Sham tDCS Preconditioning of Active rTMS
n=5 Participants
TEPs recorded after sham tDCS preconditioning and active rTMS.
|
Active tDCS Preconditioning of Active rTMS
n=5 Participants
TEPs recorded after active tDCS preconditioning and active rTMS.
|
|---|---|---|---|---|---|
|
Log Transformed P100 Amplitude of TEPs From the Global Mean Field Analysis.
|
1.85 log µV
Standard Deviation 0.71
|
1.26 log µV
Standard Deviation 0.33
|
1.59 log µV
Standard Deviation 0.82
|
1.30 log µV
Standard Deviation 0.58
|
1.11 log µV
Standard Deviation 0.48
|
Adverse Events
Cumulative Report of Adverse Events
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cumulative Report of Adverse Events
n=10 participants at risk
Adverse events data were collected irrespective of Arm/Group assignment. Adverse events were coded as either serious/nonserious, expected/unexpected, and related or unrelated to the intervention. There was only 1 adverse event (a mild headache, which was nonserious, expected and related to active rTMS).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Headache
|
10.0%
1/10 • Number of events 1 • Three lab visits over 6 weeks.
|
Additional Information
Dr Mark Mennemeier
University of Arkansas for Medical Sciences
Phone: 205 410 2413
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place