Computer-Based Training for Cognitive Enhancement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT00283010
First received: January 25, 2006
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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 Intervention
Cognitive Symptoms
Procedure: Computer-based training for cognitive enhancement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Computer-Based Training for Cognitive Enhancement: Auditory Training in Home, 2-Arm Model

Resource links provided by NLM:


Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:
  • Cognitive effects of training [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety effects of computer-based training [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 480
Study Start Date: January 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Computer-based exercises
Computer-based exercises used 4-5 hours per week, once daily.
Procedure: Computer-based training for cognitive enhancement

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283010

Locations
United States, California
Posit Science Corporation
San Francisco, California, United States, 94104
Sponsors and Collaborators
Posit Science Corporation
Investigators
Principal Investigator: Henry Mahncke, PhD Posit Science Corporation
  More Information

No publications provided

Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT00283010     History of Changes
Other Study ID Numbers: OUT-105-2005, No Secondary ID
Study First Received: January 25, 2006
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Posit Science Corporation:
cognitive enhancement in elderly
memory
auditory memory
speech
computerized
cognitive decline

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014