NCT02917109

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 ADHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

September 26, 2016

Last Update Submit

February 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Evidence of change in brain activity

    within 30 days after completing the intervention

  • Evidence of reduction in ADHD symptoms

    within 14 days after completing the intervention

  • Evidence of change in brain structure

    within 30 days after completing the intervention

  • Evidence of improvement in visual or auditory attention

    with 14 days after completing the intervention

Study Arms (1)

LearningRx cognitive training

EXPERIMENTAL

The intervention is a 60-hour, clinician-delivered cognitive training program.

Behavioral: LearningRx cognitive training

Interventions

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.

LearningRx cognitive training

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gibson Institute of Cognitive Research

Colorado Springs, Colorado, 80919, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Christina Ledbetter, PhD

    Gibson Institute of Cognitive Research

    PRINCIPAL INVESTIGATOR
  • Amy L Moore, PhD

    Gibson Institute of Cognitive Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Will add to Harvard Dataverse

Locations