Improving Time-Based Prospective Memory in TBI

Not Applicable

Active, not recruiting

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: computer-based cognitive rehabilitation (CBCR)

• Registration Number: NCT04065477
• Lead Sponsor: Kessler Foundation

Brief Summary

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).

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 Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-22
• Study Start: 2019-10-01
• Primary Completion: 2023-03-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	computer-based cognitive rehabilitation (CBCR)	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.

Primary Outcome Measures

Name	Time	Method
Recruitment rate percentage	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
Intervention Tolerability Assessment Scale	baseline through final follow-up assessment (16 weeks)	visual analog scale to assess participants' tolerability of intervention
Retention rate percentage	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 Outcome Measures

Name	Time	Method
Changes in strategic cognitive functions (performance on NIH EXAMINER)	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.
Changes in time monitoring & time-based prospective memory	16 weeks	Via a task that simultaneously assesses time monitoring frequency as it relates to time-based prospective memory performance.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States