Improving Time-Based Prospective Memory in TBI (TBPM)

January 26, 2024 updated by: Erica Weber, Kessler Foundation

Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study

This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI), particularly improving the ability to remember to do things in the future.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sustained a moderate-to-severe TBI at least one year prior to assessment
  • Fluent in English
  • Demonstrate impairment in strategic cognitive abilities

Exclusion Criteria:

  • Significant neurological history other than TBI
  • Significant psychiatric history (e.g., bipolar disorder, schizophrenia)
  • Significant substance abuse history
  • Steroid and/or benzodiazepine use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
The experimental group will receive treatment program designed to train strategic cognitive functions. Sessions will last 50 minutes and take place twice per week for 16 weeks.
Behavioral: computer-based cognitive rehabilitation (CBCR)
Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)
No Intervention: Control group
The control group will receive no active treatment and will be treated as a "no-contact control" group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Tolerability Assessment Scale
Time Frame: baseline through final follow-up assessment (16 weeks)
visual analog scale to assess participants' tolerability of intervention
baseline through final follow-up assessment (16 weeks)
Recruitment rate percentage
Time Frame: phone screen to in-person screen (within 2 weeks)
percentage of interested participants who met eligibility criteria via phone screen are eligible at in person screen
phone screen to in-person screen (within 2 weeks)
Retention rate percentage
Time Frame: baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)
adherence rate to treatment sessions within 8 weeks (i.e., attendance at 16 sessions), 12 weeks (24 sessions), and 16 weeks (32 sessions)
baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in time monitoring & time-based prospective memory
Time Frame: 16 weeks
Via a task that simultaneously assesses time monitoring frequency as it relates to time-based prospective memory performance.
16 weeks
Changes in strategic cognitive functions (performance on NIH EXAMINER)
Time Frame: 16 weeks
Via the NIH EXAMINER, a comprehensive computerized battery of tests designed to assess strategic cognitive functioning, particularly related to executive functions and related domains.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Investigators

  • Principal Investigator: Erica Weber, PhD, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

March 31, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

July 18, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1071-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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