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

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ClinicalTrials.gov Identifier: NCT00763243
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bilateral Hearing Loss
Intervention Behavioral: Cogmed Working Memory Training Program
Enrollment 9
Recruitment Details 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.
Pre-assignment Details All eligible subjects were assigned to Cogmed working memory training.
Arm/Group Title Cogmed Working Memory Training
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Cogmed Working Memory Training Program

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.

Period Title: Waiting Period
Started 9
Completed 9
Not Completed 0
Period Title: Training Period
Started 9
Completed 9
Not Completed 0
Period Title: 1-Month Follow-Up Period
Started 9
Completed 9
Not Completed 0
Period Title: 6-Month Follow-Up Period
Started 9
Completed 9
Not Completed 0
Arm/Group Title Cogmed Working Memory Training
Hide Arm/Group Description

Cogmed Working Memory Training Program

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.

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
9
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
10.2  (2.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
6
  66.7%
Male
3
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Screening Visit Pretraining Visit Posttraining Visit 1-Month Follow Up Visit 6-Month Follow Up Visit
Hide Arm/Group Description:

Screening Visit at Study Entry

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.

Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
Visit 1 month after Cogmed working memory training was completed
Visit 6 months after Cogmed working memory training completed
Overall Number of Participants Analyzed 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
11  (3.28) 11.22  (2.54) 12.89  (2.93) 13  (3.64) 11.56  (2.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Screening Visit, Pretraining Visit
Comments Change during waiting period (no intervention); no change was hypothesized
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.766
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=0.31
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-1.44 to 1.89
Parameter Dispersion
Type: Standard Deviation
Value: 2.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pretraining Visit, Posttraining Visit
Comments Change during the training period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=5.0
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
0.90 to 2.44
Parameter Dispersion
Type: Standard Deviation
Value: 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pretraining Visit, 1-Month Follow Up Visit
Comments Change from pre-training through follow-up period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=2.87
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
0.35 to 3.20
Parameter Dispersion
Type: Standard Deviation
Value: 1.86
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pretraining Visit, 6-Month Follow Up Visit
Comments Change from pretraining to 6 month follow up
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=0.89
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
-0.53 to 1.19
Parameter Dispersion
Type: Standard Deviation
Value: 1.12
Estimation Comments [Not Specified]
2.Primary Outcome
Title Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Screening Visit Pretraining Visit Posttraining Visit 1-Month Follow Up Visit 6-Month Follow Up Visit
Hide Arm/Group Description:

Screening Visit at Study Entry

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.

Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
Visit 1 month after Cogmed working memory training was completed
Visit 6 months after Cogmed working memory training completed
Overall Number of Participants Analyzed 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
13  (2.24) 14.33  (3.35) 16.78  (3.83) 16.44  (4.13) 15.11  (4.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Screening Visit, Pretraining Visit
Comments Change during waiting period of no intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=1.79
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
-0.39 to 3.05
Parameter Dispersion
Type: Standard Deviation
Value: 2.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pretraining Visit, Posttraining Visit
Comments Change during training period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=4.05
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.44
Confidence Interval (2-Sided) 95%
1.05 to 3.84
Parameter Dispersion
Type: Standard Deviation
Value: 1.81
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pretraining Visit, 1-Month Follow Up Visit
Comments 1 Month Follow Up change from pre-training
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=2.07
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.11
Confidence Interval (2-Sided) 95%
-0.24 to 4.46
Parameter Dispersion
Type: Standard Deviation
Value: 3.06
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pretraining Visit, 6-Month Follow Up Visit
Comments 6 month follow up change from pre-training
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=1.02
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
-0.97 to 2.53
Parameter Dispersion
Type: Standard Deviation
Value: 2.28
Estimation Comments [Not Specified]
3.Primary Outcome
Title Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Screening Visit Pretraining Visit Posttraining Visit 1-Month Follow Up Visit 6-Month Follow Up Visit
Hide Arm/Group Description:

Screening Visit at Study Entry

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.

Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started
Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)
Visit 1 month after Cogmed working memory training was completed
Visit 6 months after Cogmed working memory training completed
Overall Number of Participants Analyzed 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
16.89  (3.92) 17.11  (3.72) 15.33  (3.61) 16.22  (3.93) 16.44  (3.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Screening Visit, Pretraining Visit
Comments Waiting period - no treatment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.729
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=0.36
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-1.20 to 1.65
Parameter Dispersion
Type: Standard Deviation
Value: 1.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pretraining Visit, Posttraining Visit
Comments Training Period - Pretraining to Post-Training Visit
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=2.46
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.78
Confidence Interval (2-Sided) 95%
-3.44 to -0.11
Parameter Dispersion
Type: Standard Deviation
Value: 2.17
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pretraining Visit, 1-Month Follow Up Visit
Comments 1 Month Follow Up Period from Pretraining
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=0.90
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.89
Confidence Interval (2-Sided) 95%
-3.17 to 1.40
Parameter Dispersion
Type: Standard Deviation
Value: 2.98
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pretraining Visit, 6-Month Follow Up Visit
Comments 6 Month Follow Up period from pretraining
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method t-test, 2 sided
Comments t(8)=0.89
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-2.59 to 1.26
Parameter Dispersion
Type: Standard Deviation
Value: 2.50
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Screening Visit Pretraining Visit Posttraining Visit 1-Month Follow Up Visit 6-Month Follow Up Visit
Hide Arm/Group Description

Screening Visit at Study Entry

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.

Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period) Visit 1 month after Cogmed working memory training was completed Visit 6 months after Cogmed working memory training completed
All-Cause Mortality
Screening Visit Pretraining Visit Posttraining Visit 1-Month Follow Up Visit 6-Month Follow Up Visit
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Screening Visit Pretraining Visit Posttraining Visit 1-Month Follow Up Visit 6-Month Follow Up Visit
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Screening Visit Pretraining Visit Posttraining Visit 1-Month Follow Up Visit 6-Month Follow Up Visit
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: William Kronenberger, Ph.D.
Organization: Indiana University School of Medicine
Phone: 317-944-8162
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00763243     History of Changes
Other Study ID Numbers: 0808-01B
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: November 5, 2013
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017