Behavioral and Physiological Effects of Visual Training

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Posit Science Corporation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of San Francisco
Information provided by:
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT00526942
First received: September 6, 2007
Last updated: September 10, 2007
Last verified: September 2007
  Purpose

The primary objective of this study is to evaluate the learnability of a 3 week, 40 minutes per day, 5 day per week, computer-based visual training exercise by healthy mature individuals undergoing normal aging.


Condition Intervention Phase
Healthy
Behavioral: SAAGE-designed, visual memory-based cognitive training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Computer-Based Cognitive Training in Normal Healthy Aging: Pilot Study of Behavioral and Physiological Effects of Visual Sweeps Training Exercise, 2-Arm Model

Resource links provided by NLM:


Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:
  • Improvement in visual memory assessment after training or no-contact period. [ Time Frame: 6-8 weeks ]

Secondary Outcome Measures:
  • Improvement on at least 1 of the Computerized Visual Attention, Speed and Memory Tests conducted. [ Time Frame: 6-8 weeks ]
  • Improvement on the computerized cognitive assessments. [ Time Frame: 6-8 weeks ]
  • Improvement on exercise-based assessments. [ Time Frame: 6-8 weeks ]

Estimated Enrollment: 54
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
Arms Assigned Interventions
No Intervention: I
No contact control (NCC)
Experimental: II
Computerized, SAAGE-designed, visual memory-based cognitive training
Behavioral: SAAGE-designed, visual memory-based cognitive training
Training sessions take 40 minutes per day, five days per week for a total goal of 15, 40-minute sessions.
Other Name: Hawkeye

Detailed Description:

Virtually all adults will suffer a decline in their cognitive capacities to some degree. Typically, cognitive decline is characterized by a slow, progressive decline in abilities (frequently in memory, attention, inhibition and speed of processing) relative to younger adults, commonly called normal aging, age-associated memory impairment, age-consistent memory impairment, benign senescent forgetfulness, late-life forgetfulness, ageing-associated cognitive decline, and the preferred term, age-related cognitive decline (ARCD) As virtually all adults experience a reduction in their cognitive abilities with age, ARCD has generally been considered to be a normal, inevitable, and irreversible part of aging; and the extremely severe forms of pathological cognitive decline (e.g., Alzheimer's disease, AD) have dominated therapeutic research in this area. However, ARCD represents an important cause of quality of life decline in almost every older adult, as the impact of forgetfulness and mental slowing increasingly change the abilities of individuals to successfully manage their day-to-day activities. Therapeutic approaches targeting the specific problems of ARCD in normal aging (as opposed to the pathological problems of AD) would unto themselves represent important clinical advances.

This trial investigates the effects of a computer-based visual training exercise built on the principles of positive brain plasticity and designed for use by healthy mature individuals. The program is specifically designed to improve the fidelity of sensory representations in early visual cortex.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 60 or older at the time of consent.
  • Mini-Mental Status Examination (MMSE) score of 26 or higher.
  • Adequate visual capacity adequate to read.
  • Adequate hearing capacity.
  • Willing and able to commit to study time requirements.

Exclusion Criteria:

  • Self-report of current diagnosis or history of major neurological illness.
  • Self-report of current diagnosis or history of psychiatric illness. c. History of psychiatric hospitalization in the past twenty years.
  • 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. - Fibromyalgia or symptoms of severe tremor.
  • Self-report of current substance abuse, including alcoholism.
  • Current useof medications with substantial CNS effects. Inappropriate behaviors during screening or baseline visits.
  • Inability to perform behavioral evaluations.
  • Participant is not capable of giving informed consent or 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: NCT00526942

Contacts
Contact: Daniel Tinker, BS 4153943100 ext 3541 daniel.tinker@positscience.com
Contact: Cate Stasio, BA 4153943100 ext 3546 cate.stasio@positscience.com

Locations
United States, California
Posit Science Corporation Recruiting
San Francisco Bay Area, California, United States, 94104
Contact: Daniel Tinker, BS    415-394-3100 ext 3541    daniel.tinker@positscience.com   
Contact: Cate Stasio, BA    4153943100 ext 3546    cate.stasio@positscience.com   
Principal Investigator: Joseph L Hardy, PhD         
Sub-Investigator: Daniel Tinker, BS         
Sponsors and Collaborators
Posit Science Corporation
University of San Francisco
Investigators
Principal Investigator: Joseph L Hardy, PhD Posit Science Corporation
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00526942     History of Changes
Other Study ID Numbers: RES-203-2007
Study First Received: September 6, 2007
Last Updated: September 10, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Posit Science Corporation:
ACRD
Visual Memory
Visual Perception
Speed
Computerized
SAAGE
Cognitive Decline

ClinicalTrials.gov processed this record on July 22, 2014