Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants

Bilateral Hearing Loss Clinical Trial

Official title:

Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00763243
• Other study ID #: 0808-01B
• Status: Active, not recruiting
• Phase: N/A
• First received: September 26, 2008
• Last updated: May 2, 2012
• Start date: August 2008
• Est. completion date: August 2012

Study information

• Verified date: April 2012
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is an investigation of the effect of a computer-based working memory training program on memory and language processing in at-risk children (e.g., those with working memory weaknesses) who have received cochlear implants.

Description:

The long-term goal of this research program is to improve speech-language outcomes in prelingually deaf children who receive CIs. The objective of this proposal is to investigate the short-term effects of a novel working memory training program on memory, learning, and speech-language outcomes in children with CIs. The specific hypothesis of this project is that completion of a behaviorally-based training program designed to increase working memory capacity will improve attention, working memory span, and working memory-related speech-language processing in a group of deaf children with CIs. This hypothesis is based on past research demonstrating the efficacy of working memory training programs in improving attention and working memory in children with attention deficits, as well as on past research showing an association between working memory and speech-language outcomes in children with CIs. Knowledge about the effects of working memory training on CI speech-language outcomes will provide a better understanding of the process by which children with CIs learn speech-language following implantation and may offer an entirely new avenue of intervention to improve speech-language outcomes, particularly in deaf children who show limited improvement following implantation.

The specific aims of this study are:

1. Specific Aim 1: Determine the feasibility and application of a novel, computer-based working memory training program when applied to children with CIs. We hypothesize that children with CIs will show a progression of learning in both auditory and visual working memory during the training program that will mirror that of normal-hearing children.

2. Specific Aim 2: Determine the effect of the working memory training program on core attention, concentration, and working memory processes of children with CIs. We hypothesize that children with CIs will show improvement on both laboratory-based and parent-report measures of attention, concentration, and working memory processes after working memory training, compared to a baseline period.

3. Specific Aim 3: Determine the effect of the working memory training program on working memory-related speech-language outcome measures in children with CIs. We hypothesize that children with CIs will show improvement on auditory working memory, verbal naming fluency, and word repetition after training.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

• age 7-16 years at the time of study enrollment,

• profound bilateral hearing loss (> 90 dB HL in the better hearing ear),

• implantation prior to age 3 years,

• use of multichannel CI's,

• a monolingual English home environment,

• enrollment in an aural rehabilitative program that encourages the development of speaking and listening skills,

• educational environment that uses oral or total communication (TC) strategies,

• sufficient speech perception and language competence to complete basic word and sentence repetition tasks,

• no significant developmental delay or neurological condition that, in the opinion of the investigators, would interfere markedly with cognitive functioning,

• Windows-based PC at home capable of running Cogmed working memory training software,

• mild or greater deficit in working memory, as shown by either (a) a Behavior Rating Inventory of Executive Function (BRIEF) working memory T-score of 50 or higher or (b) a Digit Span scaled score of 10 or lower. Subjects will be discontinued if during the study they have any new or changed intervention (including medication) that involves working memory, attention, concentration, or executive functioning.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bilateral Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Bilateral

Intervention

Other:
• Cogmed Working Memory Training Program
The Cogmed Working Memory Training program is a 5-week program of computer-based exercises that require the user to complete tasks involving verbal, visual, or combined verbal-visual memory skills. In addition to memory skills, Cogmed tasks demand attention, concentration, and reasoning skills. Users are expected to practice Cogmed exercises at home for 40 minutes/day, 5 days/week, during the 5-week training period. The program uses an adaptive algorithm that presents users with problems of increasing difficulty at a level slightly higher than that at which they have recently achieved success.

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior Rating Inventory of Executive Function (BRIEF).		all visits	No
Primary	Spatial Span		all visits	No
Primary	Digit Span		all visits	No