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CompletedNCT00763243Updated Jul 11, 2017Results posted

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

An interventional study of Cogmed Working Memory Training Program in Bilateral Hearing Loss, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by Indiana University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
7 Years to 16 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Bilateral Hearing Loss

Keywords

  • profound bilateral hearing loss with cochlear implants
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 9 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Cogmed Working Memory Training

    Cogmed Working Memory Training Program

    Behavioral: Cogmed Working Memory Training Program

Interventions

  • BehavioralCogmed 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.

    Also known as: Cogmed

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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)

  2. 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.

    Time frame: 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)

  3. 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.

    Time frame: 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)

07

Results

Posted Jul 11, 2017

Participant flow

Subjects were recruited over a 2 year period from a database of families whose children had received cochlear implants at a large university-based teaching hospital and who had consented to be contacted for participation in research studies.

Waiting Period
Participant flow — Waiting Period
MilestoneCogmed Working Memory Training
Started9
Completed9
Not completed0
Training Period
Participant flow — Training Period
MilestoneCogmed Working Memory Training
Started9
Completed9
Not completed0
1-Month Follow-Up Period
Participant flow — 1-Month Follow-Up Period
MilestoneCogmed Working Memory Training
Started9
Completed9
Not completed0
6-Month Follow-Up Period
Participant flow — 6-Month Follow-Up Period
MilestoneCogmed Working Memory Training
Started9
Completed9
Not completed0

Outcome measures

PrimaryDigit 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.

Time frame:
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)
Reported as:
Mean · Scores on a scale
Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)
Scores on a scaleScreening VisitPretraining VisitPosttraining Visit1-Month Follow Up Visit6-Month Follow Up Visit
Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)11 ± 3.2811.22 ± 2.5412.89 ± 2.9313 ± 3.6411.56 ± 2.79
Statistical analysis
  • Screening Visit vs Pretraining Visit · t-test, 2 sided · p = 0.766 · Mean difference (final values): 0.22 · 95% CI -1.44 to 1.89t(8)=0.31
  • Pretraining Visit vs Posttraining Visit · t-test, 2 sided · p = <0.001 · Mean difference (final values): 1.67 · 95% CI 0.90 to 2.44t(8)=5.0
  • Pretraining Visit vs 1-Month Follow Up Visit · t-test, 2 sided · p = 0.021 · Mean difference (final values): 1.78 · 95% CI 0.35 to 3.20t(8)=2.87
  • Pretraining Visit vs 6-Month Follow Up Visit · t-test, 2 sided · p = 0.40 · Mean difference (final values): 0.33 · 95% CI -0.53 to 1.19t(8)=0.89
PrimarySpatial 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.

Time frame:
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)
Reported as:
Mean · Scores on a scale
Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)
Scores on a scaleScreening VisitPretraining VisitPosttraining Visit1-Month Follow Up Visit6-Month Follow Up Visit
Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)13 ± 2.2414.33 ± 3.3516.78 ± 3.8316.44 ± 4.1315.11 ± 4.26
Statistical analysis
  • Screening Visit vs Pretraining Visit · t-test, 2 sided · p = 0.11 · Mean difference (final values): 1.33 · 95% CI -0.39 to 3.05t(8)=1.79
  • Pretraining Visit vs Posttraining Visit · t-test, 2 sided · p = 0.004 · Mean difference (final values): 2.44 · 95% CI 1.05 to 3.84t(8)=4.05
  • Pretraining Visit vs 1-Month Follow Up Visit · t-test, 2 sided · p = 0.072 · Mean difference (final values): 2.11 · 95% CI -0.24 to 4.46t(8)=2.07
  • Pretraining Visit vs 6-Month Follow Up Visit · t-test, 2 sided · p = 0.34 · Mean difference (final values): 0.78 · 95% CI -0.97 to 2.53t(8)=1.02
PrimaryBehavior 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.

Time frame:
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)
Reported as:
Mean · Scores on a scale
Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)
Scores on a scaleScreening VisitPretraining VisitPosttraining Visit1-Month Follow Up Visit6-Month Follow Up Visit
Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)16.89 ± 3.9217.11 ± 3.7215.33 ± 3.6116.22 ± 3.9316.44 ± 3.50
Statistical analysis
  • Screening Visit vs Pretraining Visit · t-test, 2 sided · p = 0.729 · Mean difference (final values): 0.22 · 95% CI -1.20 to 1.65t(8)=0.36
  • Pretraining Visit vs Posttraining Visit · t-test, 2 sided · p = 0.039 · Mean difference (final values): -1.78 · 95% CI -3.44 to -0.11t(8)=2.46
  • Pretraining Visit vs 1-Month Follow Up Visit · t-test, 2 sided · p = 0.40 · Mean difference (final values): -0.89 · 95% CI -3.17 to 1.40t(8)=0.90
  • Pretraining Visit vs 6-Month Follow Up Visit · t-test, 2 sided · p = 0.40 · Mean difference (final values): -0.67 · 95% CI -2.59 to 1.26t(8)=0.89

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Screening Visit—0/9 (0%)0/9 (0%)
Pretraining Visit—0/9 (0%)0/9 (0%)
Posttraining Visit—0/9 (0%)0/9 (0%)
1-Month Follow Up Visit—0/9 (0%)0/9 (0%)
6-Month Follow Up Visit—0/9 (0%)0/9 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cogmed Working Memory Training
<=18 years9
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(years)Cogmed Working Memory Training
Mean10.2 ± 2.2
Sex: Female, Male
Sex: Female, Male(Participants)Cogmed Working Memory Training
Female6
Male3
Region of Enrollment
Region of Enrollment(participants)Cogmed Working Memory Training
United States9
08

Study locations

1 site
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00763243
Lead sponsor
Indiana University
Responsible party
Sponsor
First posted
Sep 30, 2008
Start date
Aug 2008
Primary completion
Feb 2010
Completion
Feb 2010
Results posted
Jul 11, 2017
Last update
Jul 11, 2017

Study contacts

William G. Kronenberger, PhD
principal investigator · Indiana University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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