Clinical trial NCT00763243: Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants
Official title: Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Hearing Loss
Keywords: profound bilateral hearing loss with cochlear implants
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2008-09-30
Enrollment: 9
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Exclusion Criteria:

* Under 7 years or over 16 years of age at time of study entry
* Implantation after age 3 years
* Bilingual or non-English-speaking home environment
* Primary use of American Sign Language (ASL)

Primary outcomes:
measure: Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)
timeFrame: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)
measure: Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)
timeFrame: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)
measure: Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)
timeFrame: Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: William G. Kronenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: