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

NCT ID: NCT03750409

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2020-10-15

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.

Detailed 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.

Conditions

Mild to Moderate Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Helmet Active Device

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.

Group Type: ACTIVE_COMPARATOR

Helmet

Intervention Type: 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.

Helmet Sham

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.

Group Type: SHAM_COMPARATOR

Helmet

Intervention Type: 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.

Interventions

Helmet

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.

Intervention Type: DEVICE

Other Intervention Names

Photobiomodulation device

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quietmind Foundation

OTHER

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason H Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott and White Healthcare

Marvin H Berman, PhD

Role: PRINCIPAL_INVESTIGATOR

Quiet Mind Foundation

Locations

Quietmind Foundation

Elkins Park, Pennsylvania, United States

Baylor Scott and White Medical Center, Temple

Temple, Texas, United States

Countries

United States

Other Identifiers

018-209

Identifier Type: -

Identifier Source: org_study_id