Trial Outcomes & Findings for Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy (NCT NCT05419999)
NCT ID: NCT05419999
Last Updated: 2025-05-29
Results Overview
The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and has been shown to have good psychometric properties. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). This measure will be administered at the baseline assessment, prior to each therapy session, and the one-month follow-up assessment. The potential scores range from 0-80, with a lower score indicating less symptoms of PTSD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Baseline to 9 weeks (one month post study treatment)
Results posted on
2025-05-29
Participant Flow
Participant milestones
| Measure |
tDCS Plus WET
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
Sham Plus WET
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy
Baseline characteristics by cohort
| Measure |
tDCS Plus WET
n=12 Participants
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
Sham Plus WET
n=13 Participants
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.67 years
STANDARD_DEVIATION 6.54 • n=5 Participants
|
39.00 years
STANDARD_DEVIATION 9.75 • n=7 Participants
|
40.76 years
STANDARD_DEVIATION 8.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 9 weeks (one month post study treatment)The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 is currently available and has been shown to have good psychometric properties. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). This measure will be administered at the baseline assessment, prior to each therapy session, and the one-month follow-up assessment. The potential scores range from 0-80, with a lower score indicating less symptoms of PTSD.
Outcome measures
| Measure |
tDCS Plus WET
n=12 Participants
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
Sham Plus WET
n=13 Participants
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist (PCL-5)
BASELINE
|
44.30 score on a scale
Standard Error 3.74
|
43.38 score on a scale
Standard Error 3.56
|
|
Posttraumatic Stress Disorder Checklist (PCL-5)
9 WEEKS
|
22.51 score on a scale
Standard Error 3.98
|
25.11 score on a scale
Standard Error 3.78
|
PRIMARY outcome
Timeframe: 5 weeksTracking feasibility through number of subjects that complete all written exposure therapy
Outcome measures
| Measure |
tDCS Plus WET
n=12 Participants
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
Sham Plus WET
n=13 Participants
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
|---|---|---|
|
Number of Subjects That Completed All 5 WET Sessions
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline to 9 weeks (one month post study treatment)The CAPS-5 is structured interview that assesses the DSM-5 criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Additional items that are not included in the total score evaluate overall symptom duration, distress, impairment, dissociative symptoms, and global ratings by the interviewer. Scores range from 0-80, with lower scores indicating less PTSD severity.
Outcome measures
| Measure |
tDCS Plus WET
n=12 Participants
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
Sham Plus WET
n=13 Participants
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
|---|---|---|
|
Clinician Administer PTSD Scale-5 (CAPS-5)
BASELINE
|
35.95 score on a scale
Standard Error 2.01
|
35.08 score on a scale
Standard Error 1.93
|
|
Clinician Administer PTSD Scale-5 (CAPS-5)
9 WEEKS
|
14.65 score on a scale
Standard Error 2.31
|
15.89 score on a scale
Standard Error 2.09
|
SECONDARY outcome
Timeframe: Baseline to 9 weeks (one month post study treatment)The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. It consists of 9 items that assess both affective and somatic symptoms related to depression and depressive disorders. Respondents rate the frequency with which they have been bothered by depressive symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0-27, with lower scores indicating less depression severity.
Outcome measures
| Measure |
tDCS Plus WET
n=12 Participants
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
Sham Plus WET
n=13 Participants
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ)
BASELINE
|
15.58 score on a scale
Standard Error 1.82
|
15.54 score on a scale
Standard Error 1.75
|
|
Patient Health Questionnaire-9 (PHQ)
9 WEEKS
|
11.00 score on a scale
Standard Error 2.07
|
10.66 score on a scale
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Baseline to 9 weeks (one month post study treatment)The GAD-7will be used to assess generalized anxiety symptomology. This is a 7-item measure that asks participants to rate the frequency with which they have been bothered by anxiety symptoms within the past two weeks on a scale ranging from 0 ("not at all") to 3 ("nearly every day"). Scores range from 0-21, with lower scores indicating less anxiety severity.
Outcome measures
| Measure |
tDCS Plus WET
n=12 Participants
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
Sham Plus WET
n=13 Participants
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
|---|---|---|
|
Generalize Anxiety Disorder-7 (GAD)
BASELINE
|
15.00 score on a scale
Standard Error 1.61
|
15.39 score on a scale
Standard Error 1.55
|
|
Generalize Anxiety Disorder-7 (GAD)
9 WEEKS
|
10.30 score on a scale
Standard Error 1.76
|
9.74 score on a scale
Standard Error 1.60
|
Adverse Events
tDCS Plus WET
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Sham Plus WET
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 |
tDCS Plus WET
n=12 participants at risk
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Soterix 1x1 tDCS mini CT: During stimulation, a current flows between the electrodes passing through the brain to complete the circuit. tDCS is hypothesized to modulate intrinsic neuronal activity by enhancing neuronal resting potential, or altering the likelihood that a neuron will (or will not) depolarize.
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
Sham Plus WET
n=13 participants at risk
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)
Sham Soterix 1x1 tDCS Mini CT: Sham setting is used on the Soterix transcranial electrical stimulator
Written Exposure Therapy (WET): An exposure-based, behavioral psychotherapy for PTSD.
|
|---|---|---|
|
Psychiatric disorders
Emotional Distress
|
41.7%
5/12 • Number of events 7 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
38.5%
5/13 • Number of events 9 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
33.3%
4/12 • Number of events 4 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
23.1%
3/13 • Number of events 3 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
|
Psychiatric disorders
Irritability
|
33.3%
4/12 • Number of events 4 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
|
Psychiatric disorders
Anxiety
|
50.0%
6/12 • Number of events 7 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
|
Psychiatric disorders
Reexperiencing
|
25.0%
3/12 • Number of events 3 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
15.4%
2/13 • Number of events 2 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
|
Psychiatric disorders
Sleep Disturbance
|
33.3%
4/12 • Number of events 6 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
23.1%
3/13 • Number of events 3 • Adverse events were assessed at every visit following the baseline assessment. Participants were assessed for AEs at sessions 1 through 5 and at the 1-month follow-up (9-weeks)
At each session, participants are asked "Have you experienced any changes for the worse since your last visit?" All reported events were documented by the research team member. Participants were also asked about the temporal nature (start/stop date), severity, impact on functioning, and whether the event is study-related or attributable to something else.
|
Additional Information
Casey Straud
University of Texas Health Science Center at San Antonio
Phone: 210-562-6700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place