Trial Outcomes & Findings for Remotely Supervised tDCS for Persistent Post-traumatic Headache (NCT NCT04012853)
NCT ID: NCT04012853
Last Updated: 2023-04-14
Results Overview
To evaluate the improvement in numbers of moderate to severe headache days per month from baseline period to end of treatment phase, and to the end of follow-up phase
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Results posted on
2023-04-14
Participant Flow
Participants completed a 28-day baseline period in which they completed daily headache diaries to validate diagnosis of PPTH.
Participant milestones
| Measure |
Treatment Arm
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Treatment Arm
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Unable to tolerate target tDCS intensity
|
1
|
0
|
Baseline Characteristics
Remotely Supervised tDCS for Persistent Post-traumatic Headache
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=13 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=13 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
45.3 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black of African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Marital Status
Married
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Marital Status
Divorce
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Marital Status
Never Married/Domestic Partnership
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education Level
High School Graduate or GED
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education Level
Some College or Technical School
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education Level
Bachelor's Degree or Higher
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Employment Status
Employed (Full or Part-Time)
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Employment Status
Disabled
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Employment Status
Retired
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Number of Headache Days (out of 28 days)
|
25.2 days
STANDARD_DEVIATION 3.7 • n=5 Participants
|
23.8 days
STANDARD_DEVIATION 4.8 • n=7 Participants
|
24.5 days
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Number of Moderate-to-Severe Headache Days (out of 28 days)
|
16.9 days
STANDARD_DEVIATION 8.3 • n=5 Participants
|
14.8 days
STANDARD_DEVIATION 6.4 • n=7 Participants
|
16.0 days
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Days of Acute Pain Medication Use (out of 28 days)
|
11.5 days
STANDARD_DEVIATION 11.3 • n=5 Participants
|
9.6 days
STANDARD_DEVIATION 7.9 • n=7 Participants
|
10.5 days
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Medication overuse
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Patient Health Questionnaire (PHQ-9)
|
14.3 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 4.6 • n=7 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Headache Impact Test (HIT-6)
|
64.2 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
63.2 units on a scale
STANDARD_DEVIATION 7.7 • n=7 Participants
|
63.6 units on a scale
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Beck's Anxiety Inventory (BAI)
|
31.6 units on a scale
STANDARD_DEVIATION 16.2 • n=5 Participants
|
22.1 units on a scale
STANDARD_DEVIATION 10.1 • n=7 Participants
|
26.4 units on a scale
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
DSM-5 PTSD Checklist (PCL-5)
|
46.2 units on a scale
STANDARD_DEVIATION 20.0 • n=5 Participants
|
42.7 units on a scale
STANDARD_DEVIATION 19.2 • n=7 Participants
|
44.3 units on a scale
STANDARD_DEVIATION 19.2 • n=5 Participants
|
|
Insomnia Sleep Index (ISI)
|
17.8 units on a scale
STANDARD_DEVIATION 8.5 • n=5 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Rivermead Post-Concussion Questionnaire (RPQ)
|
42.0 units on a scale
STANDARD_DEVIATION 13.0 • n=5 Participants
|
42.0 units on a scale
STANDARD_DEVIATION 10.0 • n=7 Participants
|
42.0 units on a scale
STANDARD_DEVIATION 11.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
To evaluate the improvement in numbers of moderate to severe headache days per month from baseline period to end of treatment phase, and to the end of follow-up phase
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month
End of Treatment (change from baseline)
|
-2.5 Days per Month
Standard Deviation 3.5
|
2.3 Days per Month
Standard Deviation 3.5
|
|
Change From Baseline in the Number of Moderate-to-Severe Headache Days Per Month
End of Follow-up (change from baseline)
|
-3.9 Days per Month
Standard Deviation 6.5
|
1.2 Days per Month
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
To evaluate improvement in total number of headache days per month, acute pain mediation used based on number of doses of medication taken from baseline period to end of treatment phase, and to end of follow-up phase in the same cohort.
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Change From Baseline in the Total Number of Headache Days Per Month
End of Treatment (change from baseline)
|
-4.0 days per month
Standard Deviation 5.2
|
1.54 days per month
Standard Deviation 3.8
|
|
Change From Baseline in the Total Number of Headache Days Per Month
End of Follow-up (change from baseline)
|
2.1 days per month
Standard Deviation 7.2
|
-0.2 days per month
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
To evaluate the impact of headaches on the quality of life measures (pain and disability) based on change in Headache impact test-6 (HIT-6) from baseline period to end of treatment phase, and to end of follow-up phase in persistent PTH. The six-item Headache Impact Test (HIT-6) provides a global measure of adverse headache impact and was developed to use in screening and monitoring patients with headaches in both clinical practice and clinical research. A total HIT-6 score ranges from 36 to 78: Little or no impact = HIT-6 score 49 or less; Some impact = HIT-6 score 50-55; Substantial impact = HIT-6 score 56-59; Severe impact = HIT-6 score 60.
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6)
End of Treatment (change from baseline)
|
-4.5 units on a scale
Standard Deviation 6.5
|
-4.0 units on a scale
Standard Deviation 7.3
|
|
Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6)
End of Follow-up (change from baseline)
|
0.8 units on a scale
Standard Deviation 5.4
|
-5.4 units on a scale
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: Change from baseline (four-week daily headache diary) following four-week treatment phase and four week post-treatment follow-up (12 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
change in days of acute pain medication use based on number of days taken during the baseline period to end of the treatment and follow up phase
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Change From Baseline in the Acute Pain Medication Days Per Month
End of Treatment (change from baseline)
|
-2.7 Days of Medication Use per Month
Standard Deviation 4.2
|
-0.4 Days of Medication Use per Month
Standard Deviation 3.7
|
|
Change From Baseline in the Acute Pain Medication Days Per Month
End of Follow-up (change from baseline)
|
3.0 Days of Medication Use per Month
Standard Deviation 6.4
|
-2.3 Days of Medication Use per Month
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
Number of participants with 50% or more reduction in monthly headache days (compared to baseline) will be evaluated.
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Number of Participants With a 50% Reduction in Headache Frequency
End of Treatment · 50% or greater reduction in headache days
|
1 Participants
|
0 Participants
|
|
Number of Participants With a 50% Reduction in Headache Frequency
End of Treatment · Less than 50% reduction in headache days
|
9 Participants
|
11 Participants
|
|
Number of Participants With a 50% Reduction in Headache Frequency
End of Follow-up · 50% or greater reduction in headache days
|
2 Participants
|
0 Participants
|
|
Number of Participants With a 50% Reduction in Headache Frequency
End of Follow-up · Less than 50% reduction in headache days
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
assess changes in patient reported depression severity - scale range from 0 to 27, with higher scores indicating more severe depression symptoms
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9)
End of Treatment (change from baseline)
|
-0.6 score on a scale
Standard Deviation 4.1
|
0.1 score on a scale
Standard Deviation 4.4
|
|
Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9)
End of Follow-up (change from baseline)
|
0.1 score on a scale
Standard Deviation 4.2
|
-1.0 score on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
Assess changes in patient reported PTSD-like symptoms - scale range from 0 to 80, with a lower score suggesting a lower incidence of PTSD
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5)
End of Treatment (change from baseline)
|
2.9 score on a scale
Standard Deviation 9.3
|
1.9 score on a scale
Standard Deviation 7.4
|
|
Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5)
End of Follow-up (change from baseline)
|
-1.4 score on a scale
Standard Deviation 17.2
|
-1.5 score on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
Assess changes in patient reported anxiety - scale range from 0 to 63, with higher score indicating greater anxiety
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI)
End of Treatment (change from baseline)
|
-3.2 score on a scale
Standard Deviation 8.6
|
1.9 score on a scale
Standard Deviation 10.5
|
|
Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI)
End of Follow-up (change from baseline)
|
-2.8 score on a scale
Standard Deviation 9.6
|
3.5 score on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Change from baseline following four-week treatment phase and four week post-treatment follow-up (8 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
Assess changes in patient reported concussion-related symptoms - scale range from 0 to 64, with higher scores indicating a worse outcome
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ)
End of Treatment (change from baseline)
|
-10.2 score on a scale
Standard Deviation 19.1
|
-4.2 score on a scale
Standard Deviation 11.7
|
|
Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ)
End of Follow-up (change from baseline)
|
-4.8 score on a scale
Standard Deviation 10.6
|
-4.0 score on a scale
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)Population: Analysis was conducted on participants completing post-treatment, and follow-up evaluations
Assess changes in patient reported insomnia/sleep disturbances - scale range from 0 to 28, with higher scores indicating increased severity of insomnia
Outcome measures
| Measure |
Treatment Arm
n=10 Participants
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=11 Participants
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
\* 1 participant was excluded due to being an outlier on multiple measures
|
|---|---|---|
|
Change From Baseline in Scores on the Insomnia Severity Index (ISI)
End of Treatment (change from baseline)
|
-0.5 score on a scale
Standard Deviation 5.5
|
0.2 score on a scale
Standard Deviation 5.1
|
|
Change From Baseline in Scores on the Insomnia Severity Index (ISI)
End of Follow-up (change from baseline)
|
-0.5 score on a scale
Standard Deviation 4.2
|
0.9 score on a scale
Standard Deviation 8.4
|
Adverse Events
Treatment Arm
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm
n=10 participants at risk
Active tDCS group
The active tDCS treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
Control Arm
n=12 participants at risk
Sham tDCS group
Sham group will receive 20 minutes of sham tDCS stimulation administered daily for five days per week and a total of 4 weeks. During the 20 minute treatment session, they will also complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Tingling Sensation
|
70.0%
7/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
91.7%
11/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
Skin and subcutaneous tissue disorders
Prickling Sensation
|
10.0%
1/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
16.7%
2/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
Skin and subcutaneous tissue disorders
Warming Sensation
|
30.0%
3/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
58.3%
7/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
Skin and subcutaneous tissue disorders
Itching
|
20.0%
2/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
25.0%
3/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
Skin and subcutaneous tissue disorders
Redness/Dry Skin
|
30.0%
3/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
0.00%
0/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
Skin and subcutaneous tissue disorders
Numbing Sensation
|
10.0%
1/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
8.3%
1/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
General disorders
Pulsing/Throbbing
|
10.0%
1/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
8.3%
1/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
General disorders
Dizziness/Lightheaded
|
10.0%
1/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
8.3%
1/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
General disorders
Vertigo
|
0.00%
0/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
8.3%
1/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
8.3%
1/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
|
General disorders
Other
|
20.0%
2/10 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
33.3%
4/12 • Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions).
Following each treatment session, in clinic or at-home, the supervisor would ask each participant to report whether they experienced (yes/no) any side-effects from a standardized list.
|
Additional Information
Dr. X. Michelle Androulakis Chief of Neurology
WJB Dorn VA Medical Center
Phone: 803-776-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place