CompletedNot Applicable

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

United States9 participantsStarted 2008-08

Plain-language 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.

Who can participate

Age range

7 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)

Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)

Trial details

NCT IDNCT00763243

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-02

Results submitted2013-11-05

View on ClinicalTrials.gov More Bilateral Hearing Loss trials