RECRUITING

Pilot Intervention With Near Infrared Stimulation

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Conditions

AgingCognitive AgingPhotobiomodulationLow Level Light TherapyNear Infrared (NIR) LightNeuromodulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The current study will test whether age-related cognitive and mood changes in older adults and those will be affected by near infrared (NIR) stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.

Official Title

Pilot Intervention With Near Infrared Stimulation: Revitalizing Cognition in Older Adults and Those With Parkinson Disease

Quick Facts

Study Start:2019-06-26
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03551392

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.

Ages Eligible for Study:65 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * No evidence of dementia or Mild Cognitive Impairment based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) scores within normal limits for age , education, and sex using the NACC Uniform Data Set (UDS) norms or Dementia Rating Scale (DRS-2) scores \<5thile), and age-appropriate delayed Story recall (i.e., WMS-III Logical Memory) and confrontation naming (Boston Naming Test)
  2. * Able to provide informed consent and perform cognitive and mood measures on a computer
  3. * At least 8th grade education and/or ability to read at 8th grade level
  4. * Willingness to be randomized to Sham or Real intervention
  5. * Can devote 12 weeks to the intervention, and additional time for pre and post testing
  6. * On stable doses of major medications; Since some older adults with subjective memory complaints may be prescribed acetylcholinererase inhibitors or related medications by their primary care physicians (i.e., donepezil, rivastigmine, galantaominhe, memantime, or other potential memory-enhancing agent(s), we will not exclude them as long as they have been on stable medications for at least two months and plan to continue this medication during study participation.
  7. * Normal functional behavior in terms of daily activities
  1. * Previous major strokes or other known significant brain abnormalities or diseases affecting cognition (i.e., multiple sclerosis, seizure disorder, brain surgery, moderate TBI, etc.). No history of brain surgery. Exceptions are a diagnosis of Parkinson's disease for the PD subgroup.
  2. * Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate to severe kidney or liver disease)
  3. * Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months. The study team is not excluding individuals who are taking antidepressants or anti-anxiety medications, however, use of antidepressants and anxiolytics will be recorded and data will be analyzed in post-hoc analyses
  4. * Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
  5. * Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention
  6. * Diagnosis of active cancer
  7. * Significant motor or visual disturbance that would prevent one from using a computer or detecting colors
  8. * Previous participation in a cognitive training study within the last 3 months or current involvement in another study involving cognitive training or intervention at the time of participation
  9. * Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal

Contacts and Locations

Study Contact

Dawn Bowers, Ph.D.
CONTACT
352-273-5270
dawnbowers@Phhp.ufl.edu
Adam Woods, Ph.D.
CONTACT
352-294-5842
ajwoods@phhp.ufl.edu

Principal Investigator

Dawn Bowers, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Florida
Adam Woods, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Florida
Gene Alexander, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Arizona

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85721
United States
University of Florida
Gainesville, Florida, 32611
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Dawn Bowers, Ph.D., PRINCIPAL_INVESTIGATOR, University of Florida
  • Adam Woods, Ph.D., PRINCIPAL_INVESTIGATOR, University of Florida
  • Gene Alexander, Ph.D., PRINCIPAL_INVESTIGATOR, University of Arizona

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 Registration Dates

Study Start Date2019-06-26
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2019-06-26
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Cognitive Aging
  • Photobiomodulation
  • Low Level Light Therapy
  • Near Infrared (NIR) Light
  • Neuromodulation

Additional Relevant MeSH Terms

  • Aging