Developing Process-Specific Verbal Memory Interventions for Veterans With TBI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Change in performance on paired-associate learning of words and face-name pairs
Study Overview
Brief 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.
Detailed Description
Memory dysfunction can result from impairments along a continuum of information processing, from poor initial acquisition of information during learning to disturbed retrieval of stored memory when it is later needed to perform a task1. The heterogeneous nature of TBI-related memory impairment is well-known, and there is a critical need to better understand such disease heterogeneity in order to enhance diagnosis and therapeutic management2. Several subtypes of memory dysfunction after TBI have been identified3,4. First, some TBI survivors exhibit impaired memory acquisition/encoding (e.g., frontal system damage)5. Second, some exhibit impaired memory consolidation/storage impairment (e.g., prominent damage to temporal lobe systems6). Third, some show impairment in retrieval of information5,7. This heterogeneity results from the variable nature and severity of underlying brain trauma resulting from unpredictable mechanical forces2,8.
It has been suggested that parsing this underlying variability should take precedence over generalities regarding the effect of TBI on memory when conceptualizing or treating memory disorders in this population8 Nevertheless, many rehabilitation programs utilize a "one size fits all" approach to memory training, based (typically) on training compensatory strategies, with no training specifically targeted to the identifiable component processes of memory that could be differentially impaired (encoding, consolidation/storage, and retrieval), and which might respond differentially to more specifically targeted treatment. This situation in clinical practice is due to the lack of evidence upon which to base informed decision-making in allocating specifically targeted memory re-training for individual survivors of TBI, based on clinical test results identifying which memory component processes are impaired (encoding, consolidation/storage, and retrieval). Because of this, there is little attempt to appropriately match patient impairment to targeted treatments.
There are existing training protocols for training these three components of memory processing, as follows: encoding (memory strategy training9), consolidation (errorless learning10), and retrieval (retrieval practice11, but their efficacy has not been tested in TBI survivors with documented impairments in each component. That is, to the investigators' knowledge, there is no solid evidence for memory training in TBI survivors that supports the widely held belief that specifically matching the patient impairment to the treatment leads to better treatment outcomes. This proposal attempts to fill this gap in the investigators' knowledge. Prior to testing the efficacy of these three types of training in a large trial, it is important to make standard preparations, such as refining and testing training materials and ensuring fidelity of treatment methods across clinicians.
Aim 1. Aim 1 is to refine and validate three separate, process-specific memory rehabilitation treatments that focus on improving information-processing at the encoding, consolidation, or retrieval stage for Veterans with chronic moderate/severe TBI.
Objective 1.1. Generate treatment manuals for three process-specific memory treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Interview
- •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.
Outcomes
Primary Outcomes
Change in performance on paired-associate learning of words and face-name pairs
Time Frame: At the end of each session (twice weekly), up to 12 weeks
Participants will be tested each session on paired-associate learning (words and face-name pairs) for trained and untrained items
Change in functional brain connectivity within memory-relevant brain networks
Time Frame: Prior to start of intervention (Week 0) and again at the end of intervention (Week 8)
Participants will undergo MRI scanning before and after memory interventions to assess the effect of intervention on functional brain connectivity in default mode network (DMN), task-positive network (TPN), and salience network (SN)
Secondary Outcomes
- Satisfaction with Life Scale (SWLS)(Week 0, Week 8, and 1 month after treatment is concluded (Week 12))
- Ecologically Oriented Neurorehabilitation of Memory (EON-MEM) Everyday Memory Simulations(Week 0, Week 8, and 1 month after treatment is concluded (Week 12))
- PROMIS and Neuro-QOL Item Banks(Week 0, Week 8, and 1 month after treatment is concluded (Week 12))
- Quality of Life after Brain Injury (QOLIBRI)(Week 0, Week 8, and 1 month after treatment is concluded (Week 12))
- Mayo-Portland Adaptability Inventory (MPAI-4)(Week 0, Week 8, and 1 month after treatment is concluded (Week 12))
- RAVLT(Week 0, Week 8, and 1 month after treatment is concluded (Week 12))
- Brief Visuo-Spatial Learning Test-Revised (BVLT-R)(Week 0, Week 8, and 1 month after treatment is concluded (Week 12))
