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New treatment option for Aging
Official title Pilot Intervention With Near Infrared Stimulation
ClinicalTrials.gov ID: NCT03551392
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 89. Healthy volunteers may be eligible.
You may be able to join if
- No evidence of dementia or Mild Cognitive Impairment based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) scores within normal...
- Able to provide informed consent and perform cognitive and mood measures on a computer
- At least 8th grade education and/or ability to read at 8th grade level
- Willingness to be assigned by chance to Sham or Real intervention
- Can devote 12 weeks to the intervention, and additional time for pre and post testing
You likely can't join if
- Previous major strokes or other known significant brain abnormalities or diseases affecting cognition (i.e., multiple sclerosis, seizure disorder...
- Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate to severe kidney or liver disease)
- Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive...
- Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
- Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention
- Diagnosis of active cancer
See the full eligibility criteria
- 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...
- Able to provide informed consent and perform cognitive and mood measures on a computer
- At least 8th grade education and/or ability to read at 8th grade level
- Willingness to be assigned by chance to Sham or Real intervention
- Can devote 12 weeks to the intervention, and additional time for pre and post testing
- 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...
- Normal functional behavior in terms of daily activities
- 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...
- Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate to severe kidney or liver disease)
- 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...
- Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
- Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention
- Diagnosis of active cancer
- Significant motor or visual disturbance that would prevent one from using a computer or detecting colors
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 89 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.