Improvement in Memory With Plasticity-Based Adaptive Cognitive Training (IMPACT) (IMPACT)
October 29, 2015 updated by: Posit Science Corporation
The primary objective of this study is to evaluate the effects of a computer-based training program on the memory and cognitive abilities of mature individuals undergoing healthy aging.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The computer-based training program is focused on speech reception to strengthen an individual's memory for speech. This type of training program was chosen because speech perception and memory are crucial elements of human communication and losses in this area are often the first signal of overall cognitive decline.
Subjects meeting eligibility criteria and providing written, informed consent are randomized to one of two 40-session, computerized training programs.
Study Type
Interventional
Enrollment (Actual)
487
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94108
- Posit Science Corporation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 65 or older at the time of consent.
- Mini-Mental State Examination (MMSE) score of 26 or higher.
- Fluent English speaker. For the purposes of this study, fluency will be defined as living in an English speaking country and attending an English speaking school by the age of six (participants will demonstrate fluency by reading aloud a selected paragraph).
- Visual capacity adequate to read 14 point type (participants will demonstrate visual capacity by reading aloud a selected sentence).
- Adequate hearing capacity. (Participants will demonstrate by repeating a series of words spoken by the screening clinician; the words will be spoken while a view of the clinician's mouth is obstructed to prevent lip-reading.)
- Willing and able to commit to the 6-month time requirement of the entire study period with an emphasis on availability for the 8-10 week computer based training.
Exclusion Criteria:
- Mini-Mental State Examination (MMSE) score of 25 or lower.
Self-report of current diagnosis or history of major neurological illness. Specifically:
- Alzheimer's disease
- Parkinson's disease
- Multiple sclerosis
- Amyotrophic lateral sclerosis
Self-report of current diagnosis or history of psychiatric illness. Specifically:
- Major depressive disorder
- Bipolar disorder
- Schizophrenia
- Post traumatic stress disorder
- Obsessive-compulsive disorder
- Self-reported history of psychiatric hospitalization.
- History of a stroke, transient ischemic attack (TIA), or traumatic brain injury within the past year; or lifetime history of stroke, TIA, or traumatic brain injury that has left residual expressive or receptive language problems. Traumatic brain injuries include, but are not limited to: concussion with loss of consciousness; head trauma with loss of consciousness; persistent migraines (persistent being defined as a predictable pattern occurring more frequently than every other month); and history of seizure disorder.
- Fibromyalgia or symptoms of tremor severe enough to prevent the use of a computer mouse or other pointing device. Clinician to observe participant during signature of consent form, during drawing portion of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) assessment, and to directly ask participant as instructed in the Body Image Ideals Questionnaire (BIQ) to make tremor assessment.
- Self-report of current substance abuse, including alcoholism.
- Current use, or use within the past 3 months, of medications with substantial central nervous system (CNS) effects, including acetylcholinesterase inhibitors and medications with either anticholinergic or antidepressant properties.
- Behaviors during screening or baseline visits that, in the judgment of the screening clinician, are likely to present significant problems for the trainers in the in home setting may be excluded at the discretion of the clinician. Such behaviors include significant uncooperative behavior, significant rudeness or temper management problems, or inappropriate physical conduct.
- Unable to perform neuropsychological evaluations.
- Participant is not capable of giving informed consent or is unable to comprehend and/or follow instructions.
- Participant is enrolled in a concurrent clinical study that could affect the outcome of this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Treatment
Computerized Plasticity-Based Adaptive Cognitive Training
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Other Names:
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Active Comparator: Active Control
Educational DVDs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cognitive effects of training
Time Frame: 6 months
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety effects of computer-based training
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
- Zelinski EM, Spina LM, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Smith GE. Improvement in memory with plasticity-based adaptive cognitive training: results of the 3-month follow-up. J Am Geriatr Soc. 2011 Feb;59(2):258-65. doi: 10.1111/j.1532-5415.2010.03277.x.
- Zelinski EM, Peters KD, Hindin S, Petway KT 2nd, Kennison RF. Evaluating the relationship between change in performance on training tasks and on untrained outcomes. Front Hum Neurosci. 2014 Aug 13;8:617. doi: 10.3389/fnhum.2014.00617. eCollection 2014.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
January 25, 2006
First Submitted That Met QC Criteria
January 25, 2006
First Posted (Estimate)
January 27, 2006
Study Record Updates
Last Update Posted (Estimate)
November 1, 2015
Last Update Submitted That Met QC Criteria
October 29, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- OUT-105-2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.