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NCT04065477 Clinical Trial

Improving Time-Based Prospective Memory in TBI

Traumatic Brain Injury Clinical Trial

— TBPM  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04065477
Other study ID # E-1071-19
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date March 31, 2024

Study information
Verified date January 2024
Source Kessler Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 9
Est. completion date March 31, 2024
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• computer-based cognitive rehabilitation (CBCR)
Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)

Locations
Country Name City State
United States Kessler Foundation East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intervention Tolerability Assessment Scale visual analog scale to assess participants' tolerability of intervention baseline through final follow-up assessment (16 weeks)
Primary Recruitment rate percentage 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)
Primary Retention rate percentage 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 Changes in time monitoring & time-based prospective memory Via a task that simultaneously assesses time monitoring frequency as it relates to time-based prospective memory performance. 16 weeks
Secondary Changes in strategic cognitive functions (performance on NIH EXAMINER) 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
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