Trial Outcomes & Findings for Effect of tDCS Timing on Safety Memory in PTSD (NCT NCT04152772)
NCT ID: NCT04152772
Last Updated: 2025-10-21
Results Overview
Main protocol: Threat reactivity as quantified by skin conductance responses to a conditioned and subsequently extinguished stimulus versus a never conditioned stimulus.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Study visit day 4: during administration of fear extinction memory.
Results posted on
2025-10-21
Participant Flow
Participant milestones
| Measure |
Active Then Sham Transcranial Direct Current Stimulation
Participants received 2mA transcranial direct current stimulation (tDCS) during extinction learning of conditioned threat, followed by sham tDCS for the same duration
|
Sham Then Active Transcranial Direct Current Stimulation
Participants received sham transcranial direct current stimulation (tDCS) during extinction learning of conditioned threat, followed by active, 2mA tDCS
|
Sham Then Sham Transcranial Direct Current Stimulation
Participants received sham transcranial direct current stimulation (tDCS) during extinction learning of conditioned threat, followed by sham tDCS
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
23
|
|
Overall Study
COMPLETED
|
19
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant did not disclose their age
Baseline characteristics by cohort
| Measure |
Active Then Sham Transcranial Direct Current Stimulation
n=19 Participants
Participants received 2mA transcranial direct current stimulation (tDCS) during extinction learning of conditioned threat, followed by sham tDCS for the same duration
|
Sham Then Active Transcranial Direct Current Stimulation
n=20 Participants
Participants received sham transcranial direct current stimulation (tDCS) during extinction learning of conditioned threat, followed by active, 2mA tDCS
|
Sham Then Sham Transcranial Direct Current Stimulation
n=23 Participants
Participants received sham transcranial direct current stimulation (tDCS) during extinction learning of conditioned threat, followed by sham tDCS
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 14.7 • n=19 Participants • One participant did not disclose their age
|
46.9 years
STANDARD_DEVIATION 15.5 • n=19 Participants • One participant did not disclose their age
|
43.7 years
STANDARD_DEVIATION 16.6 • n=23 Participants • One participant did not disclose their age
|
45.2 years
STANDARD_DEVIATION 15.5 • n=61 Participants • One participant did not disclose their age
|
|
Sex: Female, Male
Female
|
15 Participants
n=19 Participants
|
13 Participants
n=20 Participants
|
21 Participants
n=23 Participants
|
49 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=19 Participants
|
7 Participants
n=20 Participants
|
2 Participants
n=23 Participants
|
13 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=23 Participants
|
3 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=19 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=23 Participants
|
59 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=19 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=62 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=19 Participants
|
19 Participants
n=20 Participants
|
18 Participants
n=23 Participants
|
54 Participants
n=62 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=23 Participants
|
3 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=62 Participants
|
|
Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5
|
48.00 Average score on the PCL-5
STANDARD_DEVIATION 12.34 • n=19 Participants
|
44.80 Average score on the PCL-5
STANDARD_DEVIATION 14.48 • n=20 Participants
|
41.98 Average score on the PCL-5
STANDARD_DEVIATION 15.52 • n=23 Participants
|
44.73 Average score on the PCL-5
STANDARD_DEVIATION 14.26 • n=62 Participants
|
PRIMARY outcome
Timeframe: Study visit day 4: during administration of fear extinction memory.Main protocol: Threat reactivity as quantified by skin conductance responses to a conditioned and subsequently extinguished stimulus versus a never conditioned stimulus.
Outcome measures
| Measure |
Active tDCS During Extinction Learning Followed by Sham tDCS During Consolidation
n=19 Participants
Participants received 2mA transcranial direct current stimulation (tDCS) during extinction learning of conditioned threat, followed by sham tDCS for the same duration
|
Sham tDCS During Extinction Followed by Active tDCS During Consolidation
n=19 Participants
Participants received sham transcranial direct current stimulation (tDCS) during extinction learning of conditioned threat, followed by active, 2mA tDCS
|
Sham tDCS During Extinction Followed by Sham tDCS During Consolidation
n=21 Participants
Participants received sham transcranial direct current stimulation (tDCS) during extinction learning of conditioned threat, followed by sham tDCS
|
|---|---|---|---|
|
Skin Conductance Responses
|
0.075 Skin conductance in microsiemens
Standard Error 0.025
|
0.088 Skin conductance in microsiemens
Standard Error 0.026
|
0.057 Skin conductance in microsiemens
Standard Error 0.025
|
Adverse Events
Group 1: Active tDCS During Extinction Learning and Sham tDCS During Consolidation
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 2: Sham tDCS During Extinction Learning and Active tDCS During Consolidation
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 3: Sham tDCS During Extinction Learning and Sham tDCS During Consolidation
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Active tDCS During Extinction Learning and Sham tDCS During Consolidation
n=19 participants at risk
In group 1 active tDCS was applied during the extinction learning phase followed by sham tDCS during the consolidation phase.
Transcranial direct current stimulation included 15 minutes of 2 mA intensity.
|
Group 2: Sham tDCS During Extinction Learning and Active tDCS During Consolidation
n=20 participants at risk
In group 2 sham tDCS was applied during the extinction learning phase followed by active tDCS during the consolidation phase.
Transcranial direct current stimulation included 15 minutes of 2 mA intensity.
|
Group 3: Sham tDCS During Extinction Learning and Sham tDCS During Consolidation
n=23 participants at risk
In group 3 sham tDCS was applied during the extinction learning phase followed by sham tDCS during the consolidation phase.
No transcranial direct current stimulation was applied.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/19 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
5.0%
1/20 • Number of events 1 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
8.7%
2/23 • Number of events 2 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
|
Skin and subcutaneous tissue disorders
Neck or scalp pain
|
0.00%
0/19 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
5.0%
1/20 • Number of events 1 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
4.3%
1/23 • Number of events 1 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
|
Nervous system disorders
Ringing or buzzing in ears
|
0.00%
0/19 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
0.00%
0/20 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
0.00%
0/23 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
|
Psychiatric disorders
Acute mood change
|
15.8%
3/19 • Number of events 3 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
10.0%
2/20 • Number of events 2 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
30.4%
7/23 • Number of events 7 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
|
Nervous system disorders
Difficulty concentrating
|
5.3%
1/19 • Number of events 1 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
10.0%
2/20 • Number of events 2 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
8.7%
2/23 • Number of events 2 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
|
Nervous system disorders
Feeling sleepy or drowsy
|
47.4%
9/19 • Number of events 9 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
60.0%
12/20 • Number of events 12 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
39.1%
9/23 • Number of events 9 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
|
Nervous system disorders
Experience of flickering lights
|
26.3%
5/19 • Number of events 5 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
5.0%
1/20 • Number of events 1 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
4.3%
1/23 • Number of events 1 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
|
Nervous system disorders
Feeling dizzy or lightheaded
|
0.00%
0/19 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
5.0%
1/20 • Number of events 1 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
4.3%
1/23 • Number of events 1 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
|
Gastrointestinal disorders
Feeling nauseous
|
0.00%
0/19 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
0.00%
0/20 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
0.00%
0/23 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
|
Skin and subcutaneous tissue disorders
Skin sensations/redness
|
68.4%
13/19 • Number of events 13 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
85.0%
17/20 • Number of events 17 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
69.6%
16/23 • Number of events 16 • One day, following active tDCS or sham stimulation
A transcranial direct current stimulation side effects questionnaire was used following active tDCS or sham stimulation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place