Improving Time-Based Prospective Memory in TBI

NCT04065477 | Unknown DMC

• 1 other identifier: E-1071-19
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; TBI; Brain Injury

Outcome Measures

Primary Outcomes (3)

• Intervention Tolerability Assessment Scale

  visual analog scale to assess participants' tolerability of intervention

  baseline through final follow-up assessment (16 weeks)

• 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)

• 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 Outcomes (2)

• Changes in time monitoring & time-based prospective memory

  16 weeks

• Changes in strategic cognitive functions (performance on NIH EXAMINER)

  16 weeks

Study Arms (2)

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)

Control group

NO INTERVENTION

The control group will receive no active treatment and will be treated as a "no-contact control" group.

Interventions

computer-based cognitive rehabilitation (CBCR) BEHAVIORAL

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

Experimental

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Erica Weber, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Study staff conducting baseline and follow-up assessments will be blind as to which group participants are placed. Study staff conducting intervention sessions will be blind to participants' baseline and follow-up assessment performance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: August 22, 2019
• Study Start: October 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)