Back to resultsImproving Time-Based Prospective Memory in TBI (TBPM)
Primary Purpose
Traumatic Brain Injury
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computer-based cognitive rehabilitation (CBCR)
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, TBI, Brain Injury
Eligibility Criteria
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
Sites / Locations
- Kessler Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control group
Arm Description
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.
The control group will receive no active treatment and will be treated as a "no-contact control" group.
Outcomes
Primary Outcome Measures
Intervention Tolerability Assessment Scale
visual analog scale to assess participants' tolerability of intervention
Recruitment rate percentage
percentage of interested participants who met eligibility criteria via phone screen are eligible at in person screen
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)
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04065477
Brief Title
Improving Time-Based Prospective Memory in TBI
Acronym
TBPM
Official Title
Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, TBI, Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive no active treatment and will be treated as a "no-contact control" group.
Intervention Type
Behavioral
Intervention Name(s)
computer-based cognitive rehabilitation (CBCR)
Intervention Description
Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)
Primary Outcome Measure Information:
Title
Intervention Tolerability Assessment Scale
Description
visual analog scale to assess participants' tolerability of intervention
Time Frame
baseline through final follow-up assessment (16 weeks)
Title
Recruitment rate percentage
Description
percentage of interested participants who met eligibility criteria via phone screen are eligible at in person screen
Time Frame
phone screen to in-person screen (within 2 weeks)
Title
Retention rate percentage
Description
adherence rate to treatment sessions within 8 weeks (i.e., attendance at 16 sessions), 12 weeks (24 sessions), and 16 weeks (32 sessions)
Time Frame
baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)
Secondary Outcome Measure Information:
Title
Changes in time monitoring & time-based prospective memory
Description
Via a task that simultaneously assesses time monitoring frequency as it relates to time-based prospective memory performance.
Time Frame
16 weeks
Title
Changes in strategic cognitive functions (performance on NIH EXAMINER)
Description
Via the NIH EXAMINER, a comprehensive computerized battery of tests designed to assess strategic cognitive functioning, particularly related to executive functions and related domains.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Weber, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Time-Based Prospective Memory in TBI
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