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

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

Sponsors

Lead Sponsor: Baylor Research Institute

Collaborator: Quietmind Foundation

Source Baylor Research Institute
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.

Overall Status Recruiting
Start Date October 15, 2018
Completion Date October 15, 2020
Primary Completion Date October 15, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Memory Score Before first treatment, at 4 weeks and then at 8 weeks.
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog test) test Before first treatment, at 4 weeks and then at 8 weeks.
Quantitative Electro Encephalography (QEEG) Before first treatment, at 4 weeks and then at 8 weeks.
Enrollment 100
Condition
Intervention

Intervention Type: Device

Intervention Name: Helmet

Description: 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 Name: 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)

Gender: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Xiaoming (Ming) Qi

Phone: 254-724-7261

Email: [email protected]

Location
Facility: Status: Contact:
Quietmind Foundation | Elkins Park, Pennsylvania, 19027, United States Recruiting Marvin Berman, PhD 610-940-0488 [email protected]
Baylor Scott and White Medical Center, Temple | Temple, Texas, 76508, United States Recruiting Samantha Beevers 254-724-5679 [email protected]
Location Countries

United States

Verification Date

March 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Helmet Active Device

Type: Active Comparator

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.

Label: Helmet Sham

Type: Sham Comparator

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Double blind

Source: ClinicalTrials.gov