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NCT Number: NCT04065477

Improving Time-Based Prospective Memory in TBI

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

East Hanover, New Jersey, 07936, United States

About this 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), particularly improving the ability to remember to do things in the future.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-based cognitive rehabilitation (CBCR)

Behavioral

Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)

Primary outcomes

  1. Intervention Tolerability Assessment Scale

    Time frame: baseline through final follow-up assessment (16 weeks)

    visual analog scale to assess participants' tolerability of intervention

  2. 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

  3. 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)

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

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

Acronym: TBPM

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Aug 22, 2019
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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