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

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00763243
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bilateral Hearing Loss	Behavioral: Cogmed Working Memory Training Program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Cogmed Working Memory Training Cogmed Working Memory Training Program

Behavioral: 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.; Other Names: Cogmed

Outcome Measures

Primary Outcome Measures

1. Digit Span Total Raw Score (Construct Measured: 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)]

   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.

2. Spatial Span Total Raw Score (Construct Measured: 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)]

   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.

3. Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral 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)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 16 Years
• Sexes Eligible for Study: 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:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riley Hospital for Children	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

• Principal Investigator: William G. Kronenberger, PhD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT00763243
• Other Study ID Numbers: 0808-01B
• First Posted: Sep 30, 2008
• Last Update Posted: Jul 11, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Indiana University: profound bilateral hearing loss with cochlear implants
• Additional relevant MeSH terms: Hearing Loss; Deafness; Hearing Loss, Bilateral

Study Results

Participant Flow

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 Detail	All eligible subjects were assigned to Cogmed working memory training.

Arm/Group Title	Cogmed Working Memory Training
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.
Period Title: Waiting Period
STARTED	9
COMPLETED	9
NOT COMPLETED	0
Period Title: Waiting Period
STARTED	9
COMPLETED	9
NOT COMPLETED	0
Period Title: Waiting Period
STARTED	9
COMPLETED	9
NOT COMPLETED	0
Period Title: Waiting Period
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cogmed Working Memory Training
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 Participants	9
Age (Count of Participants)
<=18 years	9 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.2 (2.2)
Sex: Female, Male (Count of Participants)
Female	6 66.7%
Male	3 33.3%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screening Visit	Pretraining Visit	Posttraining Visit	1-Month Follow Up Visit	6-Month Follow Up Visit
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
Measure Participants	9	9	9	9	9
Mean (Standard Deviation) [Scores on a scale]	11 (3.28)	11.22 (2.54)	12.89 (2.93)	13 (3.64)	11.56 (2.79)

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
Statistical Test of Hypothesis	p-Value	0.766
	Comments
	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

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
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	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

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
Statistical Test of Hypothesis	p-Value	0.021
	Comments
	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

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
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	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

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screening Visit	Pretraining Visit	Posttraining Visit	1-Month Follow Up Visit	6-Month Follow Up Visit
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
Measure Participants	9	9	9	9	9
Mean (Standard Deviation) [Scores on a scale]	13 (2.24)	14.33 (3.35)	16.78 (3.83)	16.44 (4.13)	15.11 (4.26)

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
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	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

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
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	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

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
Statistical Test of Hypothesis	p-Value	0.072
	Comments
	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

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
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	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

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screening Visit	Pretraining Visit	Posttraining Visit	1-Month Follow Up Visit	6-Month Follow Up Visit
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
Measure Participants	9	9	9	9	9
Mean (Standard Deviation) [Scores on a scale]	16.89 (3.92)	17.11 (3.72)	15.33 (3.61)	16.22 (3.93)	16.44 (3.50)

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
Statistical Test of Hypothesis	p-Value	0.729
	Comments
	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

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
Statistical Test of Hypothesis	p-Value	0.039
	Comments
	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

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
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	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

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
Statistical Test of Hypothesis	p-Value	0.40
	Comments
	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

Adverse Events

Arm/Group Title	Screening Visit		Pretraining Visit		Posttraining Visit		1-Month Follow Up Visit		6-Month Follow Up Visit
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Screening Visit		Pretraining Visit		Posttraining Visit		1-Month Follow Up Visit		6-Month Follow Up Visit
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Screening Visit		Pretraining Visit		Posttraining Visit		1-Month Follow Up Visit		6-Month Follow Up Visit
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.