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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

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).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: computer-based cognitive rehabilitation (CBCR) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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

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



Primary Outcome Measures :
  1. Intervention Tolerability Assessment Scale [ Time Frame: baseline through final follow-up assessment (16 weeks) ]
    visual analog scale to assess participants' tolerability of intervention

  2. 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

  3. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065477


Contacts
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Contact: Michael G Di Benedetto, MA 973-324-8391 mdibenedetto@kesslerfoundation.org
Contact: Erica Weber, PhD 973-324-8451 eweber@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Michael Di Benedetto, MA    973-324-8391    mdibenedetto@kesslerfoundation.org   
Contact: Nancy Moore, MA    973-324-8450    nbmoore@kesslerfoundation.org   
Sub-Investigator: Nancy D Chiaravalloti, PhD         
Principal Investigator: Erica Weber, PhD         
Sub-Investigator: John DeLuca, PhD         
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Erica Weber, PhD Kessler Foundation
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Responsible Party: Erica Weber, Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier: NCT04065477    
Other Study ID Numbers: E-1071-19
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erica Weber, Kessler Foundation:
Traumatic Brain Injury
TBI
Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries