Vielight Neuro RX Gamma - Feasibility Pilot

NCT03328195 | Completed

• 1 other identifier: P17.02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly.

  The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.

  Baseline to Week 12

Secondary Outcomes (13)

• Device safety according to the number of device-related adverse events

  Baseline to Week 12

• Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.

  Baseline to Week 3

• Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.

  Baseline to Week 6

• Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score

  Baseline to Week 3

• Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score

  Baseline to Week 6

Other Outcomes (1)

• Caregiver reported treatment compliance

  12 weeks

Study Arms (3)

Neuro RX Gamma synchronous

ACTIVE COMPARATOR

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.

Device: Neuro RX Gamma synchronous

Sham light therapy

SHAM COMPARATOR

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.

Device: Sham

Neuro RX Gamma asynchronous

ACTIVE COMPARATOR

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.

Device: Neuro RX Gamma asynchronous

Interventions

Neuro RX Gamma synchronous DEVICE

Twenty minute treatment, six days per week for 12 weeks

Neuro RX Gamma synchronous

Sham DEVICE

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

Sham light therapy

Neuro RX Gamma asynchronous DEVICE

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

Neuro RX Gamma asynchronous

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vielight Inc.: lead

Study Sites (1)

Toronto Memory Program

Toronto, Ontario, M3B2S7, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: November 1, 2017
• Study Start: December 4, 2017
• Primary Completion: November 12, 2021
• Study Completion: February 28, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)