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NCT Number: NCT03750409

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mild to Moderate Dementia Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quietmind Foundation, Elkins Park, Pennsylvania, United States

Loading trial locations.

About this study

Research suggests that impaired regional cerebral blood flow (rCBF) [flow of blood in certain parts of the brain] plays an important role in dementia. Infrared and near infrared light frequency has been shown to increase the activity of brain cells and provide support for the cell's ability to repair and protect themselves against further damage. This study will evaluate the effects of repeated brief exposure to near infrared light stimulation twice a day on subjects that have problems such as attention span, working memory, strategies of learning and remembering, planning, organizing, self-monitoring, inhibition and flexible thinking for an 8 week period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: Photobiomodulation device

Primary outcomes

  1. Memory Score

    Time frame: Before first treatment, at 4 weeks and then at 8 weeks.

    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.

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

    Time frame: Before first treatment, at 4 weeks and then at 8 weeks.

    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.

  3. Quantitative Electro Encephalography (QEEG)

    Time frame: Before first treatment, at 4 weeks and then at 8 weeks.

    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:

    • Delta frequencies (1-4 HZ) are produced during sleep are widespread in the frontal central region. Delta is necessary for sleep and stillness.
    • Theta frequencies (4-8 HZ) are associated with selective attention, retrieving newly learned information, and preceding sleep. Theta aids creativity and problem solving.
    • Alpha frequencies (8-12 HZ) appear in the posterior when the eyes are closed. It is associated with idling and

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Quietmind Foundation

Registry information

Official study title

Assessing Feasibility of Prolonged Repetitive Near Infrared Light Stimulation on Cognitive and Behavioral Symptoms in Early to Mid-Stage Dementia

Important dates

Study start
2018
Primary completion
2019
Study completion
2026
First posted
Nov 23, 2018
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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