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Vielight Neuro RX Gamma - Feasibility Pilot

NCT03328195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-25

No results posted yet for this study

Summary

This study tests the effects of the Neuro RX Gamma synchronous and asynchronous devices on the cognitive and behavioral functioning of subjects with moderate-to-severe Alzheimer's Disease. The Neuro RX Gamma is non-invasive and delivers near-infrared energy to the brain in daily treatment sessions at home. An optional substudy will involve the use of the Electroencephalogram (EEG) to assess the effect of the treatment devices on the electrical activity of the brain compared to sham.

Conditions

  • Alzheimer Disease

Interventions

DEVICE

Neuro RX Gamma synchronous

Twenty minute treatment, six days per week for 12 weeks

DEVICE

Sham

Twenty minutes, six days per week for 12 weeks with sham device

DEVICE

Neuro RX Gamma asynchronous

Twenty minutes, six days per week for 12 weeks with sham device

Sponsors & Collaborators

  • Vielight Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2021-11-12
Completion
2022-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03328195 on ClinicalTrials.gov