Last reviewed · How we verify
NCT03277859: SAA-TBI
Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)
NA trial testing SAA-TBI in Traumatic Brain Injury in 75 participants. Completed in 30 June 2019.
30 June 2019
Quick facts
| Lead sponsor | VA Eastern Colorado Health Care System |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 16 August 2017 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SAA-TBI
Conditions studied
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
- Post-concussive Headaches — all drugs for Post-concussive Headaches →
Sponsor
VA Eastern Colorado Health Care System — full company profile →
Who can join
Adults 18 to 55, any sex, with Traumatic Brain Injury or Post-concussive Headaches. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03277859
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other VA Eastern Colorado Health Care System trials
Trials by the same sponsor.
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- NCT04150380 — Probiotic (LGG) for Veterans With PTSD · Phase 2 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03277859 (US National Library of Medicine, public domain)
- 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 Eastern Colorado Health Care System
- Last refreshed: 23 July 2019
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/NCT03277859.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing