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

Mild to Moderate Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03750409
• Other study ID #: 018-209
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: October 15, 2020

Study information

• Verified date: July 2020
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dementia
• Mild to Moderate Dementia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Quietmind Foundation	Elkins Park	Pennsylvania
United States	Baylor Scott and White Medical Center, Temple	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Quietmind Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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: 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	Before first treatment, at 4 weeks and then at 8 weeks.