An interventional study of SAA-TBI in Traumatic Brain Injury and Post-concussive Headaches, sponsored by VA Eastern Colorado Health Care System. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by VA Eastern Colorado Health Care System · Not applicable, Interventional, and Treatment
Among 10 studies in Brain Injuries, Traumatic by VA Eastern Colorado Health Care System — 1 open to participants now, 1 under way, none of them phase 3. Brain Injuries, Traumatic · VA Eastern Colorado Health Care System.
Among the 10 studies in Brain Injuries, Traumatic by VA Eastern Colorado Health Care System, this one is the only one that started in 2017, is one of 2 with no phase, and was the 9th registered.
1,722 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
Browse Brain Injuries, Traumatic studies →1 of the 10 studies in Brain Injuries, Traumatic by VA Eastern Colorado Health Care System is open now, in 1 country. Recruiting first, the newest first:
VA Eastern Colorado Health Care System · Sites in United States
Ages 18–60
By country, each count listing its studies:
Of the 281 Brain Injuries, Traumatic studies recruiting now, 120 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
This study's enrollment of 75 is above the median of 52 across 1,089 interventional studies indexed under Brain Injuries, Traumatic.
Median enrollment 78 across the 2 interventional studies, 208 across the 8 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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VA Eastern Colorado Health Care System is the lead sponsor of 49 studies on the registry; 9 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Brain Injuries, Traumatic by VA Eastern Colorado Health Care System, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
A signature injury being sustained by Veterans from recent conflicts is mild traumatic brain injury (mTBI). For some, this condition is associated with multiple disabling post-concussive symptoms, including post-concussive headaches (PCH). PCHs are notoriously resistant to medication alone, and are associated with increased muscle tension, avoidance of physical activities, and anxiety related to having chronic pain. In this study, the feasibility (ease of implementation) of the design elements of an interventional trial of Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) will be explored. Yoga is operationalized as a practice involving physical postures, breath awareness, breathing exercises and mindfulness meditation. It is conceptualized as having three "active ingredients" (i.e., regulation of the autonomic nervous system via physical activity/breathing exercises, release of muscular tension associated with headaches, and mindfulness/acceptance). The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of an 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. Project aims will be evaluated using an experimental design where participants will be block randomized in a stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will initially receive 8 weeks of enhanced treatment as usual (ETU). The participants in the waitlist condition will be offered SAA-TBI, after the initial group has completed the intervention. Both groups of participants will complete multiple measures at baseline and after the conclusion of the intervention. Maintenance among the intervention group will also be explored. Participants will be asked to complete daily homework documenting their headaches and yoga practice outside of class, and be provided with multiple modalities (web-based, mobile app, text, or paper and pencil) by which this can be accomplished. In specific, the proposed study will evaluate the feasibility of the trial design for an accessible, non-pharmacological, yoga-based intervention for chronic PCH pain among Veterans with mTBI, with the long-term goal of informing future efficacy trials.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant will start the SAA-TBI (yoga) about 2 weeks (+/- 2 weeks) after Study Visit 3.
Behavioral: SAA-TBI
Participant will start SAA-TBI (yoga) about 10 weeks (+/- 2 weeks) after Study Visit 3.
Behavioral: SAA-TBI
Yoga twice a week for 75 minutes for 8 weeks
Headaches per week
Headache Tracking Form (HTF) will query about daily headache frequency, duration, severity, and treatment per event.
Time frame: Change from baseline to approximately 20 weeks
Ran from Aug 2017 to primary completion in Jun 2019, 22 months.
Of 443 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's 22 months is below that.
Counting every sponsor, half of 465 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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VA Eastern Colorado Health Care System