Vielight Neuro RX Gamma - Feasibility Pilot

NCT ID: NCT03328195

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2022-02-28

Brief 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.

Detailed Description

The Neuro RX Gamma system is a headset which emits pulsed near-infrared energy synchronously or asynchronously through diodes placed on the scalp and inside a nostril.

A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment synchronized, treatment asynchronized or sham (placebo). A dedicated caregiver will apply the device to the subject for 20 minute daily sessions at home, 6 days a week for a total of 12 weeks. The subject and caregiver will be required to return to the clinic for follow-up assessments after 3, 6 and 12 weeks of treatment. Participants will have the choice of opting into a substudy involving the collection of rest EEG recordings during the baseline and weeks 3, 6 and 12 visits.

60 patients will be enrolled in 2 clinical sites in Ontario, Canada.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Neuro RX Gamma synchronous

Neuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril.The synchronous device delivers a synchronized pulse frequency of 40 Hz from all LED clusters.

Group Type: ACTIVE_COMPARATOR

Neuro RX Gamma synchronous

Intervention Type: DEVICE

Twenty minute treatment, six days per week for 12 weeks

Sham light therapy

Sham Neuro RX Gamma device having the same appearance and sound as the Neuro RX Gamma device but does not emit the near-infrared light.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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

Neuro RX Gamma asynchronous

Neuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril. The asynchronous device alternatively delivers pulses from the intranasal and anterior LEDs vs. from the posterior LEDS.

Group Type: ACTIVE_COMPARATOR

Neuro RX Gamma asynchronous

Intervention Type: DEVICE

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

Interventions

Neuro RX Gamma synchronous

Twenty minute treatment, six days per week for 12 weeks

Intervention Type: DEVICE

Sham

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

Intervention Type: DEVICE

Neuro RX Gamma asynchronous

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age is greater than or equal to 50 years old
• Meets the criteria for probable Alzheimer's disease of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
• If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months
• Mini Mental State Examination (MMSE) score between 0-20 at screening assessment
• Severe Impairment Battery score at baseline of ≤90
• Outpatient with a reliable caregiver willing to commit to study visits and procedures

Exclusion Criteria

• Current psychiatric or other neurologic disease
• Any history of stroke, seizures, light sensitivity (polymorphous light eruption, solar urticaria, persistent light reactivity) or Lyme disease, including those taking photosensitizing medication
• Currently undergoing light therapy treatment
• Increased skin sensitivity at the treatment site including active herpes simplex in the treatment area, history of keloid formation, or history of retinoid use in the past month
• Pregnant or lactating or planning to become pregnant
• Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments
• Does not speak English at a level necessary for the completion of the assessments.
• Currently participating in another clinical research study involving an investigational product.
• Has participated in a drug or device study within the last 30 days.
• Any condition, such as agitation/aggression, that in the opinion of the investigator would cause the patient to be unable to comply with study procedures

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vielight Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Toronto Memory Program

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

P17.02

Identifier Type: -

Identifier Source: org_study_id