Trial Outcomes & Findings for Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants (NCT NCT00763243)

Last Updated: 2017-07-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome 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)

Results posted on

2017-07-11

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.

All eligible subjects were assigned to Cogmed working memory training.

Participant milestones

Participant milestones
Measure	Cogmed Working Memory Training 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.
Waiting Period STARTED	9
Waiting Period COMPLETED	9
Waiting Period NOT COMPLETED	0
Training Period STARTED	9
Training Period COMPLETED	9
Training Period NOT COMPLETED	0
1-Month Follow-Up Period STARTED	9
1-Month Follow-Up Period COMPLETED	9
1-Month Follow-Up Period NOT COMPLETED	0
6-Month Follow-Up Period STARTED	9
6-Month Follow-Up Period COMPLETED	9
6-Month Follow-Up Period NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cogmed Working Memory Training n=9 Participants 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.
Age, Categorical <=18 years	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.2 years STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

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)

Outcome measures

Outcome measures
Measure	Screening Visit n=9 Participants 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.	Pretraining Visit n=9 Participants Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started	Posttraining Visit n=9 Participants Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)	1-Month Follow Up Visit n=9 Participants Visit 1 month after Cogmed working memory training was completed	6-Month Follow Up Visit n=9 Participants Visit 6 months after Cogmed working memory training completed
Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)	11 Scores on a scale Standard Deviation 3.28	11.22 Scores on a scale Standard Deviation 2.54	12.89 Scores on a scale Standard Deviation 2.93	13 Scores on a scale Standard Deviation 3.64	11.56 Scores on a scale Standard Deviation 2.79

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Screening Visit n=9 Participants 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.	Pretraining Visit n=9 Participants Visit that occurs 2-5 Weeks after Screening Visit (at the end of the Waiting Period) and immediately before Cogmed WMT started	Posttraining Visit n=9 Participants Visit that occurs immediately after 5-week Cogmed working memory training (end of Training Period)	1-Month Follow Up Visit n=9 Participants Visit 1 month after Cogmed working memory training was completed	6-Month Follow Up Visit n=9 Participants Visit 6 months after Cogmed working memory training completed
Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)	13 Scores on a scale Standard Deviation 2.24	14.33 Scores on a scale Standard Deviation 3.35	16.78 Scores on a scale Standard Deviation 3.83	16.44 Scores on a scale Standard Deviation 4.13	15.11 Scores on a scale Standard Deviation 4.26

PRIMARY outcome

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.