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

Primary Purpose

Mild to Moderate Dementia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helmet
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Dementia focused on measuring dementia

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Quietmind Foundation
  • Baylor Scott and White Medical Center, Temple

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Helmet Active Device

Helmet Sham

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
October 16, 2018
Last Updated
August 18, 2020
Sponsor
Baylor Research Institute
Collaborators
Quietmind Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03750409
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
October 15, 2020 (Anticipated)
Study Completion Date
October 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
Quietmind Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Dementia
Keywords
dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Helmet Active Device
Arm Type
Active Comparator
Arm 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.
Arm Title
Helmet Sham
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Helmet
Other Intervention Name(s)
Photobiomodulation device
Intervention 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.
Primary Outcome Measure Information:
Title
Memory Score
Description
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.
Time Frame
Before first treatment, at 4 weeks and then at 8 weeks.
Title
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog test) test
Description
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.
Time Frame
Before first treatment, at 4 weeks and then at 8 weeks.
Title
Quantitative Electro Encephalography (QEEG)
Description
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
Time Frame
Before first treatment, at 4 weeks and then at 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason H Huang, MD
Organizational Affiliation
Baylor Scott and White Healthcare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marvin H Berman, PhD
Organizational Affiliation
Quiet Mind Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quietmind Foundation
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
Baylor Scott and White Medical Center, Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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