Cognitive Intervention to Improve Working Memory

NCT03687008 | Completed

• 1 other identifier: 92418
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescents with single ventricle heart disease (SVHD) (10 males and 10 females) with mild to moderate cognitive impairment will participate in a total of 25 computer-based working memory training sessions, each 30-40 minutes (5 days a week for 5 weeks) supervised by a trained coach. Primary objective is to evaluate the impact of the Cogmed intervention on working memory scores and the secondary objective to assess brain tissue changes with magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI) techniques, measures of mean diffusivity pre- and post-intervention.

Conditions

Single Ventricle Heart Disease

Keywords

Cognition; Working Memory; Magnetic Resonance Imaging; Cogmed

Outcome Measures

Primary Outcomes (1)

• Changes in Working Memory Index [WMI] Scores

  To be measured by the Wide Range Assessment of Memory and Learning, version 2 \[WRAML 2\], working memory index \[mean 100, SD 15\] subscale. This is an administered test by trained personnel which measures all aspects of memory \[visual, verbal, working memory, attention / concentration\]. Lower scores indicate worse working memory deficits \[1 SD below normal is \< 85\].

  Baseline, 6 weeks

Secondary Outcomes (1)

• Changes in Mean Diffusivity [MD] Values [brain tissue changes]

  Baseline, 6 weeks

Study Arms (1)

Adolescents with SVHD

EXPERIMENTAL

All adolescents will receive the intervention Cogmed. This is an in home, computer based, cognitive intervention to improve working memory, supervised by trained coaches, \[25 sessions, each 30-45 minutes, 5 days a week / 5 week duration\].

Behavioral: Cognitive Computer Based Intervention

Interventions

Cognitive Computer Based Intervention BEHAVIORAL

25 sessions \[each 30-45 minutes, 5 days a week / for 5 weeks\], supervised by trained coaches

Also known as: Cogmed Version 4.0

Adolescents with SVHD

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• be 14-18 years old
• have SVHD
• undergone Fontan completion
• understands English
• able to read computer screen
• have phone access
• MoCA score of 25 to 10

You may not qualify if:

• pregnancy
• claustrophobia
• presence of loose metal
• prior head injury or stroke
• clinical diagnosis of depression
• previous cardiac arrest and ECMO use
• currently listed for heart transplant
• known genetic syndrome
• severe developmental delay
• born less than 35 weeks gestation

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UCLA 300 Medical Plaza

Los Angeles, California, 90095, United States

Location

Study Officials

• Nancy Pike, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: one group, pre- post-intervention design

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 27, 2018
• Study Start: June 10, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

US (1)