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Improving Time-Based Prospective Memory in TBI (TBPM)

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ClinicalTrials.gov Identifier: NCT04065477
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Erica Weber, Kessler Foundation

Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • Intervention Tolerability Assessment Scale [ Time Frame: baseline through final follow-up assessment (16 weeks) ]
    visual analog scale to assess participants' tolerability of intervention
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Time-Based Prospective Memory in TBI
Official Title  ICMJE Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
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.
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE Behavioral: computer-based cognitive rehabilitation (CBCR)
Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: computer-based cognitive rehabilitation (CBCR)
  • No Intervention: Control group
    The control group will receive no active treatment and will be treated as a "no-contact control" group.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael G Di Benedetto, MA 973-324-8391 mdibenedetto@kesslerfoundation.org
Contact: Erica Weber, PhD 973-324-8451 eweber@kesslerfoundation.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04065477
Other Study ID Numbers  ICMJE E-1071-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Erica Weber, Kessler Foundation
Study Sponsor  ICMJE Kessler Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erica Weber, PhD Kessler Foundation
PRS Account Kessler Foundation
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP