LearningRx Cognitive Training for TBI

Not Applicable

• Conditions: Traumatic Brain Injury (TBI)
• Interventions: Behavioral: LearningRx cognitive training

• Registration Number: NCT02918994
• Lead Sponsor: Gibson Institute of Cognitive Research

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Primary Completion: 2018-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LearningRx cognitive training	LearningRx cognitive training	The intervention is a 60-hour, clinician-delivered cognitive training program.

Primary Outcome Measures

Name	Time	Method
Evidence of overall cognitive function improvement	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

Name	Time	Method
Evidence of reduction in TBI symptoms	within 14 days after completing the intervention	As confirmed by pretest to post-test changes on the Traumatic Brain Injury Checklist
Evidence of change in brain structure	within 30 days after completing the intervention	Confirmed by change in pretest to post-test neuroimaging using MRI
Evidence of change in brain activity	within 30 days after completing the intervention	As confirmed by pretest to post-test changes in electrical activity measured by qEEG
Evidence of improvement in visual attention	with 14 days after completing the intervention	Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)
Evidence of improvement in auditory attention	with 14 days after completing the intervention	Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)

Trial Locations

Locations (1)

Gibson Institute of Cognitive Research; 🇺🇸 Colorado Springs, Colorado, United States