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

Study Overview
=================
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: 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. 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. 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.

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

Conditions
-----------------
Bilateral Hearing Loss

Intervention / Treatment
-----------------
* Behavioral: Cogmed Working Memory Training Program


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cogmed Working Memory Training<br>Cogmed Working Memory Training Program | Behavioral: Cogmed Working Memory Training Program<br>* 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.<br>* Other names: Cogmed;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory) | This is a measure of digit span forward and digit span backward based on the WISC-III Digit span subtest. Subjects are presented with sequences of single digits, starting with 2 digits, which increase by 1 digit after 2 sequences are presented at each digit length. The test is discontinued when 2 items are missed at the same digit length. Raw score is the number of items (digit sequences) answered correctly. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory. | 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) | 
| Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory) | This is a measure of memory for sequential spatial locations (forward and backward), based on the subject touching one of 10 blocks in the same sequence (forward) or in the reverse sequence (backward) that they were touched by the examiner. This subtest is based on the WISC-IV-Integrated Spatial Span subtest. The examiner points to blocks on a board, sequentially, starting with a sequence of two blocks (locations), which increase by 1 block (location) after 2 sequences are presented at each span length. The test is discontinued when 2 items are missed at the same spatial span length. Raw score is the number of items (complete sequences) answered correctly. The Spatial Span test is a measure of visuospatial short-term/working memory. Scores range from 0 to 28, with higher scores indicating better visuospatial short-term/working memory. | 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) | 
| Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory) | The BRIEF is a parent-report questionnaire of executive functioning behaviors in children. For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). Raw scores for subscales are sums of item scores. The Working Memory subscale consists of 10 items asking about attention, concentration, and active controlled memory. Working Memory subscale raw scores are measures of attention, concentration, and working memory, and range from 10 to 30. Higher raw scores indicate more problems with attention, concentration, and working memory. | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
profound bilateral hearing loss with cochlear implants