LearningRx Cognitive Training for TBI

Traumatic Brain Injury (TBI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02918994
• Other study ID #: GICR-0916-B
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: Gibson Institute of Cognitive Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: December 2021
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury (TBI)

Intervention

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.

Locations

Country	Name	City	State
United States	Gibson Institute of Cognitive Research	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Gibson Institute of Cognitive Research

Country where clinical trial is conducted

United States, 

Outcome

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