Clinical trial NCT03750409: Assessing Feasibility of Prolonged Repetitive Near Infrared Light Stimulation in Early to Mid-Stage Dementia
Official title: Assessing Feasibility of Prolonged Repetitive Near Infrared Light Stimulation on Cognitive and Behavioral Symptoms in Early to Mid-Stage Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild to Moderate Dementia
Keywords: dementia
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Quietmind Foundation
First posted: 2018-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Memory Score
timeFrame: Before first treatment, at 4 weeks and then at 8 weeks.
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog test) test
timeFrame: Before first treatment, at 4 weeks and then at 8 weeks.
measure: Quantitative Electro Encephalography (QEEG)
timeFrame: Before first treatment, at 4 weeks and then at 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Elkins Park
country: United States
facility: Quietmind Foundation
state: Pennsylvania
city: Temple
country: United States
facility: Baylor Scott and White Medical Center, Temple
state: Texas
Study officials:
affiliation: Baylor Scott and White Healthcare
name: Jason H Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Quiet Mind Foundation
name: Marvin H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References: