Back to resultsLearningRx Cognitive Training for TBI
Primary Purpose
Traumatic Brain Injury (TBI)
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LearningRx cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury (TBI)
Eligibility 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
Sites / Locations
- Gibson Institute of Cognitive Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LearningRx cognitive training
Arm Description
The intervention is a 60-hour, clinician-delivered cognitive training program.
Outcomes
Primary Outcome Measures
Evidence of overall cognitive function improvement
Confirmed by change in pretest to post-test scores on the Woodcock Johnson IV - Tests of Cognitive Abilities
Secondary Outcome Measures
Evidence of change in brain activity
As confirmed by pretest to post-test changes in electrical activity measured by qEEG
Evidence of reduction in TBI symptoms
As confirmed by pretest to post-test changes on the Traumatic Brain Injury Checklist
Evidence of change in brain structure
Confirmed by change in pretest to post-test neuroimaging using MRI
Evidence of improvement in visual attention
Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)
Evidence of improvement in auditory attention
Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)
Full Information
NCT ID
NCT02918994
First Posted
September 27, 2016
Last Updated
July 26, 2021
Sponsor
Gibson Institute of Cognitive Research
1. Study Identification
Unique Protocol Identification Number
NCT02918994
Brief Title
LearningRx Cognitive Training for TBI
Official Title
LearningRx Cognitive Training for Traumatic Brain Injury (TBI): A Multiple Baseline Study Across Cases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gibson Institute of Cognitive Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury (TBI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LearningRx cognitive training
Arm Type
Experimental
Arm Description
The intervention is a 60-hour, clinician-delivered cognitive training program.
Intervention Type
Behavioral
Intervention Name(s)
LearningRx cognitive training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evidence of overall cognitive function improvement
Description
Confirmed by change in pretest to post-test scores on the Woodcock Johnson IV - Tests of Cognitive Abilities
Time Frame
within 14 days after completing the intervention
Secondary Outcome Measure Information:
Title
Evidence of change in brain activity
Description
As confirmed by pretest to post-test changes in electrical activity measured by qEEG
Time Frame
within 30 days after completing the intervention
Title
Evidence of reduction in TBI symptoms
Description
As confirmed by pretest to post-test changes on the Traumatic Brain Injury Checklist
Time Frame
within 14 days after completing the intervention
Title
Evidence of change in brain structure
Description
Confirmed by change in pretest to post-test neuroimaging using MRI
Time Frame
within 30 days after completing the intervention
Title
Evidence of improvement in visual attention
Description
Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)
Time Frame
with 14 days after completing the intervention
Title
Evidence of improvement in auditory attention
Description
Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)
Time Frame
with 14 days after completing the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Ledbetter, PhD
Organizational Affiliation
Gibson Institute of Cognitive Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy L Moore, PhD
Organizational Affiliation
Gibson Institute of Cognitive Research
Official's Role
Study Director
Facility Information:
Facility Name
Gibson Institute of Cognitive Research
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80919
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Will add to Harvard Dataverse
Citations:
PubMed Identifier
32670040
Citation
Moore AL, Carpenter DM 2nd, James RL, Miller TM, Moore JJ, Disbrow EA, Ledbetter CR. Neuroimaging and Neuropsychological Outcomes Following Clinician-Delivered Cognitive Training for Six Patients With Mild Brain Injury: A Multiple Case Study. Front Hum Neurosci. 2020 Jun 24;14:229. doi: 10.3389/fnhum.2020.00229. eCollection 2020.
Results Reference
derived
Learn more about this trial
LearningRx Cognitive Training for TBI
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