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Completed

NCT Number: NCT00283010

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

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.

Completed

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Posit Science Corporation

San Francisco, California, 94108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computerized plasticity-based adaptive cognitive training

Other

Other names: BrainHQ, Brain Fitness Program

Educational DVDs

Other

Primary outcomes

  1. Cognitive effects of training

    Time frame: 6 months

Secondary outcomes

  1. Safety effects of computer-based training

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Collaborators

  • Mayo Clinic
  • University of Southern California

Registry information

Acronym: IMPACT

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 27, 2006
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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