Feasibility of Exercise and Transcranial Direct Current Stimulation for the Treatment of Post-traumatic Headache
NCT07928492, Phase 1, Completed, San Diego State University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Feasibility of Exercise and Transcranial Direct Current Stimulation for the Treatment of Post-traumatic Headache | ClinicalTrials.gov |
| NCT number | NCT07928492 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 18 participants, actual | ClinicalTrials.gov |
| Lead sponsor | San Diego State University | ClinicalTrials.gov |
| Conditions | Headaches Posttraumatic, Neck Pain | ClinicalTrials.gov |
| Interventions | Exercise, transcranial direct current stimulation | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 64
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Participant retention | From enrollment to the post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Percent of enrolled participants who complete the post-intervention assessment for each treatment arm as measured by assessment attendance logs in REDCap | ClinicalTrials.gov |
| Primary | Treatment adherence | From first to last treatment session completed (18 sessions, ~6-weeks) | Percent of prescribed treatment sessions completed by participants who are retained in each treatment arm as measured by treatment attendance logs in REDCap | ClinicalTrials.gov |
| Primary | Treatment satisfaction | From first treatment session to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Median Global Rating of Perceived Satisfaction for each treatment arm (reverse-scored range: 1 "extremely dissatisfied" to 7 "extremely satisfied") | ClinicalTrials.gov |
| Secondary | Treatment duration | From first to last treatment session completed (~ 6 weeks) | Average number of weeks required to complete 18 prescribed treatment sessions for participants retained in each treatment arm as measured by treatment attendance logs in REDCap | ClinicalTrials.gov |
| Secondary | Perceived improvement | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Median Global Rating of Perceived Improvement for each treatment arm (reverse-scored range: 1 "very much worse" to 7 "very much improved") | ClinicalTrials.gov |
| Secondary | PROMIS headache intensity, measurement responsiveness | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Pain Intensity v2.0 T-score for headache, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | PROMIS neck pain intensity, measurement responsiveness | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in PROMIS Pain Intensity v2.0 T-score for neck pain, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Headache Impact Test-6, measurement responsiveness | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in Short-Form Headache Impact Test-6 score, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Neck Pain and Disability Scale, measurement responsiveness | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in Neck Pain and Disability Scale score, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Fat Fraction, Obliquus Capitis Inferior | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Obliquus Capitis Inferior muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Fat Fraction, Rectus Capitis Posterior Major | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Rectus Capitis Posterior Major muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Fat Fraction, Rectus Capitis Posterior Minor | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Rectus Capitis Posterior Minor muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Fat Fraction, Longus Colli/Capitis C2/3 | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Longus Colli/Capitis muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Fat Fraction, Longus Colli/Capitis C5/6 | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Longus Colli/Capitis muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Fat Fraction, Sternocleidomastoid C2/3 | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Sternocleidomastoid muscle at vertebral level C2/3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Fat Fraction, Sternocleidomastoid C5/6 | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Sternocleidomastoid muscle at vertebral level C5/6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Fat Fraction, Multifidi C3 | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Multifidi muscle at vertebral level C3 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Fat Fraction, Multifidi C6 | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in fat fraction of the Multifidi muscle at vertebral level C6 measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Total Muscle Volume, Obliquus Capitis Inferior | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Obliquus Capitis Inferior muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
| Secondary | Total Muscle Volume, Rectus Capitis Posterior Major | From pre-intervention baseline to post-intervention assessment within 1-week after completing 18 treatment sessions (~ 6 weeks) | Within-group effect size (Hedge's g) for pre-post intervention change in total muscle volume of the Rectus Capitis Posterior Major muscle measured with magnetic resonance imaging, where Hedge's g \< \|0.20\| is interpreted as a "negligible effect", \|0.20-0.49\| "small", \|0.50-0.79\| "moderate", and ≥ \|0.80\| "large" | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)