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Improvement in Memory With Plasticity-Based Adaptive Cognitive Training (IMPACT) (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00283010
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : November 2, 2015
Mayo Clinic
University of Southern California
Information provided by (Responsible Party):
Posit Science Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aging Other: Computerized Plasticity-Based Adaptive Cognitive Training Other: Educational DVDs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 487 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement in Memory With Plasticity-Based Adaptive Cognitive Training (IMPACT)
Study Start Date : January 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Experimental Treatment
Computerized Plasticity-Based Adaptive Cognitive Training
Other: Computerized Plasticity-Based Adaptive Cognitive Training
Other Names:
  • BrainHQ
  • Brain Fitness Program

Active Comparator: Active Control
Educational DVDs
Other: Educational DVDs

Primary Outcome Measures :
  1. Cognitive effects of training [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety effects of computer-based training [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00283010

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United States, California
Posit Science Corporation
San Francisco, California, United States, 94108
Sponsors and Collaborators
Posit Science Corporation
Mayo Clinic
University of Southern California
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Principal Investigator: Henry W Mahncke, PhD Posit Science Corporation