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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02918994
Other study ID # GICR-0916-B
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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