CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Vielight Neuro Gammadevice
Likely dose
Vielight Neuro Gamma headset with transcranial and intranasal near-infrared light delivery (dose parameters not specified)AI-extracted
Key inclusion· 5
  • Age greater than 50 years
  • Diagnosis of dementia (preferably Alzheimer's disease) confirmed by neurologist
  • English language fluency
  • MMSE score greater than 11
Key exclusion· 6
  • Lack of assent to study procedures
  • MRI contraindications such as pacemakers, metal implants, or claustrophobia
  • Terminal illness with life expectancy less than 1 year
  • Started or planning to start dementia medication (cholinesterase inhibitor or memantine) within past 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03160027
NCT03160027N/ACompleted

Examining the Impact of Photobiomodulation (PBM) on Brain Function in Dementia

University of California, San Francisco·interventional·Posted May 19, 2017·Updated Oct 6, 2020

In Brief

A clinical study evaluating Vielight Neuro Gamma for Dementia, Alzheimer Type. Completed, enrolled 20 participants across 1 site.

Detailed Summary

A recent study (Saltmarche et al., 21017) examined the effects of photobiomodulation (PBM), a kind of light therapy that uses red or near-infrared light to heal and protect tissue that has either been injured, is degenerating, or else is at risk of dying, in 5 older adults with dementia. After 12 weeks of PBM treatments, delivered with a commercially available, wearable device, the patients with mild to moderately severe dementia showed improvements on the Mini-mental State Exam (MMSE, p\<0.003) and Alzheimer's Disease Assessment Scale-cognitive, ADAS-cog, p\<0.03). The caregivers, who kept daily journals of their experiences during the 12 weeks of PBM treatment, reported better sleep, fewer angry outbursts, decreased anxiety and wandering in their loved-ones with dementia. The goals of this trial are to: (1) replicate this finding in a larger group of individuals with dementia and (2) to examine the underling brain mechanisms behind the changes in cognitive function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 19, 2017
Enrollment StartMay 15, 2017
Primary CompletionSep 15, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.1 years ago

Interventions

Vielight Neuro Gammadevice

The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.