LearningRx Cognitive Training for TBI

July 26, 2021 updated by: Gibson Institute of Cognitive Research

LearningRx Cognitive Training for Traumatic Brain Injury (TBI): A Multiple Baseline Study Across Cases

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80919
        • Gibson Institute of Cognitive Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 14 days after completing the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 30 days after completing the intervention
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
within 30 days after completing the intervention
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
within 14 days after completing the intervention
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)
with 14 days after completing the intervention
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)
with 14 days after completing the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gibson Institute of Cognitive Research

Investigators

  • Principal Investigator: Christina Ledbetter, PhD, Gibson Institute of Cognitive Research
  • Study Director: Amy L Moore, PhD, Gibson Institute of Cognitive Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GICR-0916-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will add to Harvard Dataverse

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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