Adults 20 to 60, any sex, with Persistent Post Traumatic Headache or Mild Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Number of Moderate-to-Severe Headache Days Per MonthPrimary· Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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
End of Treatment (change from baseline)
Group
Value
95% CI
Treatment Arm
-2.5
± 3.5
Control Arm
2.3
± 3.5
End of Follow-up (change from baseline)
Group
Value
95% CI
Treatment Arm
-3.9
± 6.5
Control Arm
1.2
± 6.5
Change From Baseline in the Total Number of Headache Days Per MonthSecondary· Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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.
End of Treatment (change from baseline)
Group
Value
95% CI
Treatment Arm
-4.0
± 5.2
Control Arm
1.54
± 3.8
End of Follow-up (change from baseline)
Group
Value
95% CI
Treatment Arm
2.1
± 7.2
Control Arm
-0.2
± 4.4
Change From Baseline in the Quality of Life Based on Change in Headache Impact Test-6 (HIT-6)Secondary· Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
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 =
End of Treatment (change from baseline)
Group
Value
95% CI
Treatment Arm
-4.5
± 6.5
Control Arm
-4.0
± 7.3
End of Follow-up (change from baseline)
Group
Value
95% CI
Treatment Arm
0.8
± 5.4
Control Arm
-5.4
± 18.4
Change From Baseline in the Acute Pain Medication Days Per MonthSecondary· Change from baseline (four-week daily headache diary) following four-week treatment phase and four week post-treatment follow-up (12 weeks total)
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
End of Treatment (change from baseline)
Group
Value
95% CI
Treatment Arm
-2.7
± 4.2
Control Arm
-0.4
± 3.7
End of Follow-up (change from baseline)
Group
Value
95% CI
Treatment Arm
3.0
± 6.4
Control Arm
-2.3
± 10.2
Number of Participants With a 50% Reduction in Headache FrequencySecondary· Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Number of participants with 50% or more reduction in monthly headache days (compared to baseline) will be evaluated.
End of Treatment
Group
Value
95% CI
Treatment Arm
1
Control Arm
0
Treatment Arm
9
Control Arm
11
End of Follow-up
Group
Value
95% CI
Treatment Arm
2
Control Arm
0
Treatment Arm
8
Control Arm
11
Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9)Secondary· Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
assess changes in patient reported depression severity - scale range from 0 to 27, with higher scores indicating more severe depression symptoms
End of Treatment (change from baseline)
Group
Value
95% CI
Treatment Arm
-0.6
± 4.1
Control Arm
0.1
± 4.4
End of Follow-up (change from baseline)
Group
Value
95% CI
Treatment Arm
0.1
± 4.2
Control Arm
-1.0
± 5.6
Change From Baseline in Scores on the DSM-5 PTSD Checklist (PCL-5)Secondary· Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Assess changes in patient reported PTSD-like symptoms - scale range from 0 to 80, with a lower score suggesting a lower incidence of PTSD
End of Treatment (change from baseline)
Group
Value
95% CI
Treatment Arm
2.9
± 9.3
Control Arm
1.9
± 7.4
End of Follow-up (change from baseline)
Group
Value
95% CI
Treatment Arm
-1.4
± 17.2
Control Arm
-1.5
± 12.4
Change From Baseline in Scores on the Beck's Anxiety Inventory (BAI)Secondary· Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Assess changes in patient reported anxiety - scale range from 0 to 63, with higher score indicating greater anxiety
End of Treatment (change from baseline)
Group
Value
95% CI
Treatment Arm
-3.2
± 8.6
Control Arm
1.9
± 10.5
End of Follow-up (change from baseline)
Group
Value
95% CI
Treatment Arm
-2.8
± 9.6
Control Arm
3.5
± 10.8
Change From Baseline in Scores on the Rivermead Post-Concussion Questionnaire (RPQ)Secondary· Change from baseline following four-week treatment phase and four week post-treatment follow-up (8 weeks total)
Assess changes in patient reported concussion-related symptoms - scale range from 0 to 64, with higher scores indicating a worse outcome
End of Treatment (change from baseline)
Group
Value
95% CI
Treatment Arm
-10.2
± 19.1
Control Arm
-4.2
± 11.7
End of Follow-up (change from baseline)
Group
Value
95% CI
Treatment Arm
-4.8
± 10.6
Control Arm
-4.0
± 14.8
Change From Baseline in Scores on the Insomnia Severity Index (ISI)Secondary· Baseline (four-week daily headache diary), following four-week treatment phase, and four week post-treatment follow-up (12 weeks total)
Assess changes in patient reported insomnia/sleep disturbances - scale range from 0 to 28, with higher scores indicating increased severity of insomnia
End of Treatment (change from baseline)
Group
Value
95% CI
Treatment Arm
-0.5
± 5.5
Control Arm
0.2
± 5.1
End of Follow-up (change from baseline)
Group
Value
95% CI
Treatment Arm
-0.5
± 4.2
Control Arm
0.9
± 8.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were recorded following each daily session over the course of the four-week treatment phase (20-sessions)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This pilot study is designed to provide preliminary data for a large scale, randomized clinical trial to evaluate the efficacy of remotely administrated at home transcranial Direct Current Stimulation (tDCS) with real-time monitoring via VA Tele-health for persistent post traumatic headache associated with mild traumatic brain injury (mTBI). Participants will receive total of 20 sessions of tDCS over four weeks. The investigators anticipate that the results generated from the study will directly translate into immediate meaningful clinical application: not only in management of chronic post traumatic headache, but also in reduction of acute pain medication use, and improving quality of life for our veterans with this debilitating neurological disorder.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of transcranial direct current stimulation
Trials testing the same drug.
NCT07591194 — The Effects of Immersive Virtual Reality-Based Exergaming Combined With Transcranial Direct Current Stimulation on Execu
· NA
· not yet recruiting
NCT07534397 — Treatment of Cognitive and Sensorimotor Deficits in Parkinson's Disease With High Definition Transcranial Direct Current
· NA
· not yet recruiting
NCT06771531 — Brain Stimulation for Foot-sole Sensation in Older Adults With Foot-sole Somatosensory Deficits
· NA
· recruiting
NCT07089056 — Effects of Transcranial Direct Current Stimulation After Short-term Immobilization on Motor Learning and Hand Function i
· NA
· not yet recruiting
NCT06806267 — Study of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians
· NA
· recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
· Phase 1
· not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran
· NA
· not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness
· NA
· not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
· NA
· not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 14 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04012853.