LearningRx Cognitive Training for ADHD

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

LearningRx Cognitive Training for ADHD: A Multiple Baseline Study Across Cases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917109
• Other study ID #: GICR-0916-A
• Status: Completed
• Phase: N/A
• First received: September 26, 2016
• Last updated: February 13, 2018
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• 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 ADHD.

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 ADHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 22 Years

Eligibility

Inclusion Criteria:

• Age 15-22 previously diagnosed with ADHD

• High school students or college students with a prior diagnosis of ADHD 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

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)

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 ADHD symptoms	As confirmed by pretest to post-test changes on the ADHD Rating Scale	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 or auditory attention	Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3) and Auditory Attention Test (CATA)	with 14 days after completing the intervention