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Procedure

Neuro RX Gamma for Mild Cognitive Impairment

N/A
Recruiting
Led By Corinne Fischer, MD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 weeks post randomization
Awards & highlights

Study Summary

This trial will study the effects of transcranial near infrared light on the cognitive changes and neural correlates associated with Alzheimer's disease.

Who is the study for?
This trial is for people over 50 with mild cognitive impairment due to Alzheimer's, who function normally in daily life and have a specific score range on the MoCA test. They must be stable on certain dementia medications if used, and have a caregiver to help with home treatments. Excluded are those with substance abuse issues, unstable illnesses, non-English speakers without grade eight education level, or involvement in other drug trials.Check my eligibility
What is being tested?
The Neuro RX Gamma device uses near-infrared light therapy thought to improve brain function by enhancing mitochondrial activity. Participants will use this device at home for six weeks. The study includes clinical assessments and MRI scans before and after treatment to evaluate changes in cognition and brain activity.See study design
What are the potential side effects?
Potential side effects aren't specified but may include discomfort from wearing the device or sitting still during sessions, skin sensitivity where the light is applied, or anxiety related to using the equipment at home.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
Select...
I am 50 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 weeks post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from pre- to post-treatment on executive functioning assessed by Trail Making Test (TMT)-B/A and Stroop Color and Word Test (SCWT)
Changes from pre- to post-treatment on mental status and cognitive function assessed by Mini-Mental State Examination (MMSE)
Changes from pre- to post-treatment on processing speed assessed by Trail Making Test (TMT)-part A
+2 more
Secondary outcome measures
Changes from pre- to post-treatment on Neuropsychiatric symptoms (NPS) using MBI-C (Mild Behavioral Impairment Checklist)
Changes from pre- to post-treatment on Pittsburgh sleep quality index
Changes from pre- to post-treatment on Quality of life using QOL-AD
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Neuro Rx DeviceActive Control1 Intervention
The active device will deliver light for the 20 minutes session duration.
Group II: Sham Neuro Rx DevicePlacebo Group1 Intervention
The Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
535 Previous Clinical Trials
447,063 Total Patients Enrolled
Corinne Fischer, MDPrincipal InvestigatorUnity Health Toronto
2 Previous Clinical Trials
258 Total Patients Enrolled

Media Library

Neuro RX Gamma (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05563298 β€” N/A
Mild Cognitive Impairment Research Study Groups: Active Neuro Rx Device, Sham Neuro Rx Device
Mild Cognitive Impairment Clinical Trial 2023: Neuro RX Gamma Highlights & Side Effects. Trial Name: NCT05563298 β€” N/A
Neuro RX Gamma (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05563298 β€” N/A
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05563298 β€” N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this medical study extend to octogenarians?

"This research project is looking for elderly participants aged 50 and above, but not exceeding 95 years of age."

Answered by AI

What objectives are the researchers hoping to fulfill with this experiment?

"The primary outcome measure of this experiment, which will be observed at the Baseline and 6 weeks post randomization intervals, is changes in visuospatial memory as assessed by the BVMT-R. Secondary objectives include alterations to cortical thickness, subcortical volume, mild behavioural impairment checklist ratings, blood lactate levels/lactate/pyruvate ratio over time - all surrogate markers for mitochondrial function."

Answered by AI

Does this clinical research currently accept participants?

"According to the information provided on clinicaltrials.gov, this medical study has concluded its recruitment period and is no longer actively seeking patients. This trial was initially posted on October 15th 2022 and last updated September 28th 2022. Nonetheless, there are 591 other trials that are still recruiting subjects at present time."

Answered by AI

Am I eligible to volunteer for this medical experiment?

"To be eligible for participation, candidates must have mild cognitive disorder and fall between the ages of 50 to 95 years old. This particular trial is recruiting approximately 20 individuals."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

MCI and getting worse.
PatientReceived 2+ prior treatments
~0 spots leftby Mar 2024