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Trial record 32 of 183 for:    functional | Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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

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ClinicalTrials.gov Identifier: NCT02310633
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Memory Strategy Training Behavioral: Errorless Learning Behavioral: Retrieval Practice Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing Process-Specific Verbal Memory Interventions for Veterans With TBI
Actual Study Start Date : January 5, 2015
Estimated Primary Completion Date : December 22, 2017
Estimated Study Completion Date : December 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: Memory Strategy Training
This arm involves intervention that teaches participants to use active encoding strategies to learn and remember new information.
Behavioral: Memory Strategy Training
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.

Active Comparator: Errorless Learning
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
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.

Active Comparator: Retrieval Practice
This arm involves intervention that enhances retrieval of correct target information by actively practicing retrieval in the presence of a cue.
Behavioral: Retrieval Practice
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.




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Mayo-Portland Adaptability Inventory (MPAI-4) [ Time Frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12) ]
    This measure assesses the overall impact of TBI on functional capacity

  2. RAVLT [ Time Frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12) ]
    This is an independent measure of list learning designed to assess the effect of memory intervention on learning of untrained items.

  3. Brief Visuo-Spatial Learning Test-Revised (BVLT-R) [ Time Frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12) ]
    This is a measure of nonverbal memory (drawing from memory), designed to assess the effect of memory intervention on learning and memory for untrained items.

  4. Ecologically Oriented Neurorehabilitation of Memory (EON-MEM) Everyday Memory Simulations [ Time Frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12) ]
    These are tasks of everyday memory designed to assess whether effects of memory intervention generalize to real-world memory tasks.

  5. Quality of Life after Brain Injury (QOLIBRI) [ Time Frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12) ]
    This is a quality of life measure after brain injury, designed to assess whether effects of memory intervention extend to quality of life.

  6. PROMIS and Neuro-QOL Item Banks [ Time Frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12) ]
    These items assess outcome from the patient perspective (patient-reported outcomes)

  7. Satisfaction with Life Scale (SWLS) [ Time Frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12) ]
    This questionnaire assesses overall life quality and satisfaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310633


Contacts
Contact: Russell M Bauer, PhD Russell.Bauer@va.gov
Contact: Molly J Sullan, BA (352) 376-1611 ext 7675 msullan@phhp.ufl.edu

Locations
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: Margaret H McCallum    352-376-1611 ext 5223    Margaret.McCallum@va.gov   
Principal Investigator: Russell M Bauer, PhD         
Sponsors and Collaborators
VA Office of Research and Development
University of Florida
Investigators
Principal Investigator: Russell M Bauer, PhD North Florida/South Georgia Veterans Health System, Gainesville, FL

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02310633     History of Changes
Other Study ID Numbers: N1730-P
1I21RX001730-01 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available to other researchers in a de-identified, password protected file.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
TBI
memory disorder
injury, brain, traumatic
rehabilitation

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System