CompletedNot Applicable

Developing Process-Specific Verbal Memory Interventions for Veterans With Tramatic Brain Injury (TBI)

United States8 participantsStarted 2015-01-05

Plain-language summary

Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation Research \& Development (RR\&D) and represents a critically important public health problem facing the Veteran population. Developing efficacious treatments for persistent memory deficits seen in this population is a key step in reducing the impact that such problems have in the everyday lives of Veterans. Memory problems after TBI in Veterans are quite heterogeneous, and efficacy will likely be maximized by developing and disseminating multiple alternative treatments individually matched to the Veteran's key deficits, and by research that seeks to understand the cognitive and neural basis of treatment-related change over time. The results of this approach may aid clinical decision making and assignment of patients to rehabilitative treatments most likely to improve memory capacity and functional outcome.

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Veterans aged 25-65 who are post-deployment, * having served in Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), or Operation New Dawn (OND), * who meet criteria for moderate or severe TBI during deployment, * are eligible to participate. * Patients will meet the 2007 VA/DoD criteria54, * supplemented by data from the VA TBI Identification Semi-Structured Interview55. * All patients will have gone through Level I and II assessments with positive findings. * Primary inclusion criteria: * Moderate to Severe Traumatic Brain Injury (M-STBI) (blast and blunt), * \> 6 months post-injury, * no receptive aphasia (impairing ability to comprehend task instructions), * able to participate in return visits. Exclusion Criteria: * Primary exclusion criteria: * No MRI contraindications, * not claustrophobic, * no current or past history of disabling Axis I psychiatric disorders (except for PTSD and depression), * no active substance abuse, * not pregnant.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in performance on paired-associate learning of words and face-name pairs

Timeframe: At the end of each session (twice weekly), up to 12 weeks

Change in functional brain connectivity within memory-relevant brain networks

Timeframe: Prior to start of intervention (Week 0) and again at the end of intervention (Week 8)

Trial details

NCT IDNCT02310633

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2017-12-22

View on ClinicalTrials.gov More Traumatic Brain Injury trials