Trial Outcomes & Findings for Motor Cortex as a Research & Therapeutic Target in TMD (NCT NCT02247063)
NCT ID: NCT02247063
Last Updated: 2020-04-01
Results Overview
Self-reported VAS from 0 (no pain) to 10 (worst possible pain)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Post tDCS sessions compared to baseline (one week)
Results posted on
2020-04-01
Participant Flow
Participant milestones
| Measure |
Placebo
The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
Experimental
The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Motor Cortex as a Research & Therapeutic Target in TMD
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
Experimental
n=12 Participants
The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
Total
n=24 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
35.2 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post tDCS sessions compared to baseline (one week)Self-reported VAS from 0 (no pain) to 10 (worst possible pain)
Outcome measures
| Measure |
Placebo
n=12 Participants
The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
Experimental
n=12 Participants
The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
|---|---|---|
|
Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline
|
4 participants
|
9 participants
|
SECONDARY outcome
Timeframe: One month after tDCS sessions compared to baseline (6 weeks)Self-reported VAS from 0 (no pain) to 10 (worst possible pain)
Outcome measures
| Measure |
Placebo
n=12 Participants
The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
Experimental
n=12 Participants
The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
|---|---|---|
|
Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline
|
4 participants
|
9 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Experimental
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
Experimental
n=12 participants at risk
The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain.
|
|---|---|---|
|
General disorders
Headache
|
66.7%
8/12 • 5 weeks
|
58.3%
7/12 • 5 weeks
|
|
General disorders
Neck Pain
|
66.7%
8/12 • 5 weeks
|
66.7%
8/12 • 5 weeks
|
|
General disorders
Scalp Pain
|
83.3%
10/12 • 5 weeks
|
66.7%
8/12 • 5 weeks
|
|
General disorders
Scalp Burn (Sensation)
|
33.3%
4/12 • 5 weeks
|
50.0%
6/12 • 5 weeks
|
|
General disorders
Tingling
|
91.7%
11/12 • 5 weeks
|
83.3%
10/12 • 5 weeks
|
|
General disorders
Skin Redness
|
8.3%
1/12 • 5 weeks
|
16.7%
2/12 • 5 weeks
|
|
General disorders
Sleepiness
|
83.3%
10/12 • 5 weeks
|
75.0%
9/12 • 5 weeks
|
|
General disorders
Trouble Concentrating
|
75.0%
9/12 • 5 weeks
|
25.0%
3/12 • 5 weeks
|
|
General disorders
Mood Change
|
41.7%
5/12 • 5 weeks
|
25.0%
3/12 • 5 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place