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Trial record 1 of 1 for:    02918994
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LearningRx Cognitive Training for TBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02918994
Recruitment Status : Active, not recruiting
First Posted : September 29, 2016
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Gibson Institute of Cognitive Research

Study Description
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Brief Summary:
The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with Traumatic Brain Injury (TBI).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury (TBI) Behavioral: LearningRx cognitive training Not Applicable

Detailed Description:
Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for TBI.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LearningRx Cognitive Training for Traumatic Brain Injury (TBI): A Multiple Baseline Study Across Cases
Study Start Date : September 2016
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LearningRx cognitive training
The intervention is a 60-hour, clinician-delivered cognitive training program.
 Behavioral: LearningRx cognitive training
A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.


Outcome Measures
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Primary Outcome Measures :
  1. Evidence of overall cognitive function improvement [ Time Frame: within 14 days after completing the intervention ]
    Confirmed by change in pretest to post-test scores on the Woodcock Johnson IV - Tests of Cognitive Abilities


Secondary Outcome Measures :
  1. Evidence of change in brain activity [ Time Frame: within 30 days after completing the intervention ]
    As confirmed by pretest to post-test changes in electrical activity measured by qEEG

  2. Evidence of reduction in TBI symptoms [ Time Frame: within 14 days after completing the intervention ]
    As confirmed by pretest to post-test changes on the Traumatic Brain Injury Checklist

  3. Evidence of change in brain structure [ Time Frame: within 30 days after completing the intervention ]
    Confirmed by change in pretest to post-test neuroimaging using MRI

  4. Evidence of improvement in visual attention [ Time Frame: with 14 days after completing the intervention ]
    Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)

  5. Evidence of improvement in auditory attention [ Time Frame: with 14 days after completing the intervention ]
    Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18+ previously diagnosed with TBI
  • Living in the greater Colorado Springs area

Exclusion Criteria:

  • No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging
Contacts and Locations
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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): NCT02918994


Locations
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United States, Colorado
Gibson Institute of Cognitive Research
Colorado Springs, Colorado, United States, 80919
Sponsors and Collaborators
Gibson Institute of Cognitive Research
Investigators
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Principal Investigator: Christina Ledbetter, PhD Gibson Institute of Cognitive Research
Study Director: Amy L Moore, PhD Gibson Institute of Cognitive Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gibson Institute of Cognitive Research
ClinicalTrials.gov Identifier: NCT02918994    
Other Study ID Numbers: GICR-0916-B
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will add to Harvard Dataverse
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