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

Baylor Scott and White Health (BSWH)

Status: Unknown

Conditions: Mild to Moderate Dementia

Treatments: Device: Helmet

Study type: Interventional

Funder types: Other

Identifiers

NCT03750409

018-209

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Helmet Active Device

Active Comparator group

Description:

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.

Treatment:

Device: Helmet

Helmet Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Helmet