Verbal Working Memory and Attention Remediation for Adults With Traumatic Brain Injury.

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04349852
Status
Recruiting

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BrainHQ Cognitive Training Modules — BEHAVIORAL
    The BrainHQ is a computerized training program developed from Posit Science designed to improve multiple cognitive domains. The subtests exercises include 6 modules for the experimental group: 1) Sound Sweeps: which is identify whether sound pitches are going up or down; 2) Memory Grids: matching pairs of words; 3) Syllable Stack: recognition of sequences of confusable syllables; 4) Fine Tuning: recognition of the order of confusable syllables; 5) To-Do List Training: reconstruction of sequences of verbal instructions; 6) In The Know: identification of details in a verbally presented story. Since the intervention is presented both visually and verbally through the computer, participants will be asked to complete their training in a quiet space and time to complete these activities.
  • BrainHQ People Skills Modules — BEHAVIORAL
    The BrainHQ is a computerized training program developed from Posit Science designed to improve multiple cognitive domains. BrainHQ will provide 6 training modules for the control group: Crossword Puzzle - retrieve words according to the provided prompts. Lineup Four - Connect four colored discs so that they form a line in the horizontal, vertical or diagonal direction. Bricks Breaking Hex -Connect and remove bricks of the same color to clear the board. War Ship (Similar to Battleship)- place 5 vessels in the area at the left-hand side and sink enemy's hidden ships at the right-hand side by guessing enemy ship locations. Gem Swap - Form a line of 3 or more identical gems by swapping their positions. Sudoku - Fill each row, column, and 3x3 square with numbers 1 to 9 without repetition. Participants will spend 35 minutes at each training session. Participants will be asked to complete their training in a quiet space and time to complete these activities.

Study Details

This project will examine if computerized cognitive remediation will improve working memory and attention in 25 adults with a mild, moderate, or severe brain injury and compare their cognitive performance to the control group of 25 adults with a mild, moderate, or severe brain injury. The control group will train on computerized Brain Games. Participants in both groups will be assessed prior to training and immediately post-training and one month-post training.

Key Dates

Start date
Aug 1, 2021
Status verified
Apr 2026
Primary completion
Sep 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BrainHQ Cognitive Training Arm
    BrainHQ Cognitive Training Arm Participants will be randomized into the BrainHQ Cognitive Training modules which are 35 minute training sessions. There will be 30 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked if they have a quiet space and noise cancelling headphones. Participants will complete the training protocols remotely and their performance will be tracked. Participants will complete the 30 training sessions remotely, but will meet with the study team member online prior to beginning the exercises and right after completing the session.
  • Other: BrainHQ People Skills Arm
    Participants will be randomized into the BrainHQ's Brain Game exercises which are 35 minute training sessions. There will be 30 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked to complete the training in a quiet space and time to complete these activities. Participants will complete the 30 training sessions remotely, but will meet with the study team member online each training session prior to beginning the exercises and right after completing the exercises.

Primary Outcome Measure

Change in participants' logical memory after participating in BrainHQ training [ Time Frame: baseline, 1 week post training, 4 weeks post training ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
George Voelbel, PhD
212-998-5827
George Voelbel, Phd (PRINCIPAL_INVESTIGATOR)

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