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

NCT02310633 | Completed

• 2 other identifiers: N1730-P1I21RX001730-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

TBI; memory disorder; injury, brain, traumatic; rehabilitation

Outcome Measures

Primary Outcomes (2)

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

  Participants will be tested each session on paired-associate learning (words and face-name pairs) for trained and untrained items

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

• Change in functional brain connectivity within memory-relevant brain networks

  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)

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

Secondary Outcomes (7)

• 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)

• Ecologically Oriented Neurorehabilitation of Memory (EON-MEM) Everyday Memory Simulations

  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)

Study Arms (3)

Memory Strategy Training

ACTIVE COMPARATOR

This arm involves intervention that teaches participants to use active encoding strategies to learn and remember new information.

Behavioral: Memory Strategy Training

Errorless Learning

ACTIVE COMPARATOR

This arm involves intervention that enhances consolidation of correct target information by preventing false recall of incorrect information during the acquisition phase.

Behavioral: Errorless Learning

Retrieval Practice

ACTIVE COMPARATOR

This arm involves intervention that enhances retrieval of correct target information by actively practicing retrieval in the presence of a cue.

Behavioral: Retrieval Practice

Interventions

Memory Strategy Training BEHAVIORAL

This intervention involves intervention that teaches participants to use active encoding strategies to learn and remember new information. The intervention will be implemented using verbal and face-name paired associate learning.

Memory Strategy Training

Errorless Learning BEHAVIORAL

This intervention enhances consolidation of correct target information by preventing false recall of incorrect information during the acquisition phase. Participants are encouraged to recall target information only if they are sure it is correct, thus eliminating errors. The intervention will be implemented using verbal and face-name paired associate learning.

Errorless Learning

Retrieval Practice BEHAVIORAL

This intervention enhances retrieval of correct target information by actively practicing retrieval in the presence of a cue. The intervention will be implemented using verbal and face-name paired associate learning.

Retrieval Practice

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Florida: collaborator

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Related Links

• Home page for the Gainesville VA Brain Rehabilitation Research Center of Excellence

MeSH Terms

Conditions

Brain Injuries, Traumatic; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Russell M Bauer, PhD

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: December 8, 2014
• Study Start: January 5, 2015
• Primary Completion: December 22, 2017
• Study Completion: December 29, 2017
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)