Trial Outcomes & Findings for High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury (NCT NCT03799458)
NCT ID: NCT03799458
Last Updated: 2025-04-08
Results Overview
The NSI is a validated scale of postconcussive symptoms; the Somatic Subscale score captures severity of physical symptoms such as tinnitus, blurry vision, loss of balance, and insomnia. (range 0-48; 0-12 mild; 13-24 moderate; 25-36 severe; 37-48 very severe)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
2 week visit
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
Active Stimulation
Active HD-tDCS will be delivered while subjects perform sensory training tasks.
Active High-definition transcranial direct current stimulation (HD-tDCS): Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates.
|
Sham Stimulation
Sham HD-tDCS will be delivered while subjects perform sensory training tasks.
Sham High-definition transcranial direct current stimulation (HD-tDCS): Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates
|
Imaging Only
40 subjects will undergo initial testing only as a healthy control group.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
37
|
|
Overall Study
COMPLETED
|
11
|
10
|
29
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Active Stimulation TBI Group
n=11 Participants
Subjects have experienced a mild TBI with ongoing symptoms. Active HD-tDCS will be delivered while subjects perform sensory training tasks.
Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates. Sham delivers a negligible amount of current that does not cause physiological changes.
|
Sham Stimulation TBI Group
n=10 Participants
Subjects have experienced a mild TBI with ongoing symptoms. Sham HD-tDCS will be delivered while subjects perform sensory training tasks.
Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates. Sham delivers a negligible amount of current that does not cause physiological changes.
|
Imaging Only Control Group
n=28 Participants
Subjects will undergo initial testing only as a healthy control group.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 10.1 • n=93 Participants
|
49.7 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
51.4 years
STANDARD_DEVIATION 13.2 • n=27 Participants
|
49.2 years
STANDARD_DEVIATION 11.8 • n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
10 participants
n=4 Participants
|
28 participants
n=27 Participants
|
49 participants
n=483 Participants
|
|
Neurobehavioral Symptom Inventory Somatic Subscale Score
|
19.9 units on a scale
STANDARD_DEVIATION 10.5 • n=93 Participants
|
18.9 units on a scale
STANDARD_DEVIATION 11.3 • n=4 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 3.3 • n=27 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 7.4 • n=483 Participants
|
PRIMARY outcome
Timeframe: 2 week visitPopulation: For active and sham, analysis population includes all participants who completed intervention and all pre-intervention and post-intervention visit assessments. For imaging only group, analysis includes all participants who completed all pre-intervention visit assessments.
The NSI is a validated scale of postconcussive symptoms; the Somatic Subscale score captures severity of physical symptoms such as tinnitus, blurry vision, loss of balance, and insomnia. (range 0-48; 0-12 mild; 13-24 moderate; 25-36 severe; 37-48 very severe)
Outcome measures
| Measure |
Active Stimulation
n=11 Participants
Active HD-tDCS will be delivered while subjects perform sensory training tasks.
Active High-definition transcranial direct current stimulation (HD-tDCS): Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates.
|
Sham Stimulation
n=10 Participants
Sham HD-tDCS will be delivered while subjects perform sensory training tasks.
Sham High-definition transcranial direct current stimulation (HD-tDCS): Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates
|
Imaging Only
n=28 Participants
40 subjects will undergo initial testing only as a healthy control group.
|
|---|---|---|---|
|
Postconcussive Sensory Symptoms
Pre-Intervention (baseline visit)
|
19.9 score on a scale
Standard Deviation 10.5
|
18.9 score on a scale
Standard Deviation 11.3
|
2.9 score on a scale
Standard Deviation 3.3
|
|
Postconcussive Sensory Symptoms
Post-Intervention (2 week visit)
|
20.6 score on a scale
Standard Deviation 9.4
|
17.5 score on a scale
Standard Deviation 9.5
|
—
|
SECONDARY outcome
Timeframe: 2 week visitPopulation: For active and sham intervention groups, analysis population includes all participants who completed intervention
Peak activation during the Auditory Orienting Task (AOT) performed during magnetoencephalography
Outcome measures
| Measure |
Active Stimulation
n=11 Participants
Active HD-tDCS will be delivered while subjects perform sensory training tasks.
Active High-definition transcranial direct current stimulation (HD-tDCS): Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates.
|
Sham Stimulation
n=10 Participants
Sham HD-tDCS will be delivered while subjects perform sensory training tasks.
Sham High-definition transcranial direct current stimulation (HD-tDCS): Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates
|
Imaging Only
n=28 Participants
40 subjects will undergo initial testing only as a healthy control group.
|
|---|---|---|---|
|
Magnetoencephalography Peak Activation
Pre-Intervention (baseline visit)
|
3.07 femtotesla
Standard Deviation 0.87
|
3.49 femtotesla
Standard Deviation 0.92
|
3.31 femtotesla
Standard Deviation 0.90
|
|
Magnetoencephalography Peak Activation
Post-Intervention (2 week visit)
|
3.68 femtotesla
Standard Deviation 1.42
|
3.46 femtotesla
Standard Deviation 1.03
|
—
|
Adverse Events
Active Stimulation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham Stimulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Imaging Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Stimulation
n=21 participants at risk
Active HD-tDCS will be delivered while subjects perform sensory training tasks.
Active High-definition transcranial direct current stimulation (HD-tDCS): Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates.
|
Sham Stimulation
n=21 participants at risk
Sham HD-tDCS will be delivered while subjects perform sensory training tasks.
Sham High-definition transcranial direct current stimulation (HD-tDCS): Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates
|
Imaging Only
n=37 participants at risk
40 subjects will undergo initial testing only as a healthy control group.
|
|---|---|---|---|
|
Nervous system disorders
syncope
|
4.8%
1/21 • Number of events 1 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
4.8%
1/21 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
0.00%
0/37 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/21 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
4.8%
1/21 • Number of events 1 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
0.00%
0/37 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
|
Nervous system disorders
headache
|
4.8%
1/21 • Number of events 1 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
4.8%
1/21 • Number of events 1 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
0.00%
0/37 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
|
Psychiatric disorders
nightmares
|
4.8%
1/21 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
0.00%
0/21 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
0.00%
0/37 • adverse event data was collected for the "Active Stimulation" and "Sham Stimulation" Arms during the 2-week stimulation period between Visit 1 and Visit 2; adverse event data were collected over a single day at Baseline for participants in the "Imaging Only" Arm.
|
Additional Information
Dr. Davin Quinn
University of New Mexico Health Sciences Center
Phone: 505-272-2223
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place