Assessing Feasibility of Prolonged Repetitive Near Infrared Light Stimulation in Early to Mid-Stage Dementia

NCT03750409 | Active Not Recruiting FDA Device

• 1 other identifier: 018-209
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study will gather data to see if infrared and near infrared light frequency can increase the activity of brain cells and provide support for the cell's ability to repair and protect themselves against further damage.

Conditions

Mild to Moderate Dementia

Keywords

dementia

Outcome Measures

Primary Outcomes (3)

• Memory Score

  Mini Mental State Exam will be performed in beginning of the study (before first treatment), in the middle of the treatment (in 4 weeks) and in the end of treatment (in the end of 8 weeks). This quick assessment will be able to score assessed individuals using 0-30 scoring range. Collected scores will be compared at different time points and any numerical change in score will be evaluated.

  Before first treatment, at 4 weeks and then at 8 weeks.

• Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog test) test

  ADAS-Cog test will be performed in beginning of the study (before first treatment), in the middle of the treatment (in 4 weeks) and in the end of treatment (in the end of 8 weeks) to measure cognition. This comprehensive test will measure patient's ability of language and memory. Test consist of 11 parts and will help to assess baseline and determine cognitive change over period of treatment using patient's ability to answer questions and given score.

  Before first treatment, at 4 weeks and then at 8 weeks.

• Quantitative Electro Encephalography (QEEG)

  QEEG measurement will be performed in beginning of the study (before first treatment), in the middle of the treatment (in 4 weeks) and in the end of treatment (in the end of 8 weeks). This measurement will use modern analytic software to process activity of the brain during cognitive task in the forms of electrical signals received from the surface of the scalp. Analytical software uses algorithms to assess recorded brain impulses and evaluate brain function, helping to track changes in the brain function due to treatment. Waveforms of EEG being assessed: 1. Delta frequencies (1-4 HZ) are produced during sleep are widespread in the frontal central region. Delta is necessary for sleep and stillness. 2. Theta frequencies (4-8 HZ) are associated with selective attention, retrieving newly learned information, and preceding sleep. Theta aids creativity and problem solving. 3. Alpha frequencies (8-12 HZ) appear in the posterior when the eyes are closed. It is associated with idling and

  Before first treatment, at 4 weeks and then at 8 weeks.

Study Arms (2)

Helmet Active Device

ACTIVE COMPARATOR

Patients will be randomized 2:1 ratio to receive either the helmet active device or the helmet sham matched device. EACH device will be delivered with a highly visible tag with either an 'A' or 'B' respective to the study group the patient was randomized to.

Device: Helmet

Helmet Sham

SHAM COMPARATOR

Patients will be randomized 2:1 ratio to receive either the helmet active device or the helmet sham matched device. EACH device will be delivered with a highly visible tag with either an 'A' or 'B' respective to the study group the patient was randomized to.

Device: Helmet

Interventions

Helmet DEVICE

The portable device covers the head and weighs about 3.5 lb., and is made of light-weight, durable plastic, it is placed on the head with eye panels facing forward. Elastic straps holding the arrays together easily expand to conform to each subjects' head. Patients may notice slight warming of scalp after usage. This warming effect is similar to wearing a regular motorcycle helmet for a similar duration.

Also known as: Photobiomodulation device

Helmet Active Device; Helmet Sham

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50-85 years with an independently provided diagnosis of dementia, probable Alzheimer's type.
• Dementia symptoms not greater than early to mid-stage dementia
• Generally healthy as indicated by recent physical examination within the last 6 months
• If labs are available within the last 6 months, renal function, hepatic function, cardiac function should be normal

You may not qualify if:

• Diagnosed actively growing intracranial pathology (tumors etc.)
• Misusing illegal substances or alcohol
• Previous history of stroke
• History of aggression or violence
• History of major psychiatric illness
• No underlying CNS pathology (confined to tumor, epilepsy only)

Sponsors & Collaborators

• Baylor Research Institute: lead
• Quietmind Foundation: collaborator

Study Sites (2)

Quietmind Foundation

Elkins Park, Pennsylvania, 19027, United States

Location

Baylor Scott and White Medical Center, Temple

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Dementia

Interventions

Head Protective Devices

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jason H Huang, MD

  Baylor Scott and White Healthcare

  PRINCIPAL INVESTIGATOR

• Marvin H Berman, PhD

  Quiet Mind Foundation

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 23, 2018
• Study Start: October 15, 2018
• Primary Completion: August 27, 2019
• Study Completion (Estimated): July 15, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)