Your session is about to expire
← Back to Search
Procedure
Laser Therapy for Mild Cognitive Impairment (PBMCI2 Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age is greater than or equal to 50 years old
Be older than 18 years old
Must not have
Unstable medical illness (e.g., uncontrolled diabetes mellitus or hypertension)
History of stroke, seizures, multiple sclerosis (MS), or Lyme disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 13 - four weeks after the post-treatment assessments
Summary
This trial aims to explore the use of Photobiomodulation (PBM) therapy, also known as low-level laser therapy, as a potential treatment for Mild Cognitive Impairment (MCI
Who is the study for?
This trial is for individuals with mild cognitive impairment (MCI) or early Alzheimer's disease. Participants should be experiencing memory loss, confusion, and difficulty with thinking and reasoning. Those who have other serious medical conditions that could interfere with the study or are currently receiving certain treatments for MCI may not qualify.
What is being tested?
The trial is testing a device called Neuro RX Gamma (v2), which uses near-infrared light to stimulate brain regions affected by MCI. It compares the effects of an active tPBM device against a sham (inactive) device to see if it can improve symptoms related to cognitive decline.
What are the potential side effects?
Since photobiomodulation therapy is non-invasive and doesn't produce significant heat, side effects are expected to be minimal. However, potential risks may include discomfort at the site of application or temporary visual disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My diabetes or blood pressure is not under control.
Select...
I have a history of stroke, seizures, MS, or Lyme disease.
Select...
I have no history of severe agitation, seizures, or light sensitivity, except for Alzheimer's.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 13 - four weeks after the post-treatment assessments
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 13 - four weeks after the post-treatment assessments
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cognition
Secondary study objectives
Blood biomarkers
Imaging biomarker
Quality of life
Other study objectives
Follow up blood-based biomarker
Follow up cognition
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active groupActive Control1 Intervention
The active group will undergo a 8-week trial of home-use tPBM using the active Neuro RX Gamma (v2) device, 6 days/week, 20 minutes per session.
Group II: Sham groupPlacebo Group1 Intervention
The sham group will undergo a 8-week trial of home-use PBM using the sham Neuro RX Gamma (v2) device, 6 days/week, 20 minutes per session.
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
562 Previous Clinical Trials
453,891 Total Patients Enrolled
The W. Garfield Weston FoundationUNKNOWN
3 Previous Clinical Trials
151 Total Patients Enrolled