Back to resultsVielight Neuro RX Gamma - Feasibility Pilot
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Neuro RX Gamma synchronous
Sham
Neuro RX Gamma asynchronous
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Age is greater than or equal to 50 years old
- Meets the criteria for probable Alzheimer's disease of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months
- Mini Mental State Examination (MMSE) score between 0-20 at screening assessment
- Severe Impairment Battery score at baseline of ≤90
- Outpatient with a reliable caregiver willing to commit to study visits and procedures
Exclusion Criteria:
- Current psychiatric or other neurologic disease
- Any history of stroke, seizures, light sensitivity (polymorphous light eruption, solar urticaria, persistent light reactivity) or Lyme disease, including those taking photosensitizing medication
- Currently undergoing light therapy treatment
- Increased skin sensitivity at the treatment site including active herpes simplex in the treatment area, history of keloid formation, or history of retinoid use in the past month
- Pregnant or lactating or planning to become pregnant
- Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments
- Does not speak English at a level necessary for the completion of the assessments.
- Currently participating in another clinical research study involving an investigational product.
- Has participated in a drug or device study within the last 30 days.
- Any condition, such as agitation/aggression, that in the opinion of the investigator would cause the patient to be unable to comply with study procedures
Sites / Locations
- Toronto Memory Program
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
Active Comparator
Arm Label
Neuro RX Gamma synchronous
Sham light therapy
Neuro RX Gamma asynchronous
Arm Description
Neuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril.The synchronous device delivers a synchronized pulse frequency of 40 Hz from all LED clusters.
Sham Neuro RX Gamma device having the same appearance and sound as the Neuro RX Gamma device but does not emit the near-infrared light.
Neuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril. The asynchronous device alternatively delivers pulses from the intranasal and anterior LEDs vs. from the posterior LEDS.
Outcomes
Primary Outcome Measures
Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly.
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
Secondary Outcome Measures
Device safety according to the number of device-related adverse events
Subjects will be monitored for clinical evidence of device-related adverse events throughout the study.
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence.
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence.
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence.
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating).
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating).
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating).
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change.
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change.
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change.
Change in the Electroencephalogram's (EEG) overall power spectral density
The EEG recordings will give insight into the effect on the neural activity of the brain of the Neuro RX Gamma synchronized and Neuro RX Gamma asynchronized compared to sham.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03328195
Brief Title
Vielight Neuro RX Gamma - Feasibility Pilot
Official Title
A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma Device for the Treatment of Moderate-to-severe Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vielight Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study tests the effects of the Neuro RX Gamma synchronous and asynchronous devices on the cognitive and behavioral functioning of subjects with moderate-to-severe Alzheimer's Disease. The Neuro RX Gamma is non-invasive and delivers near-infrared energy to the brain in daily treatment sessions at home. An optional substudy will involve the use of the Electroencephalogram (EEG) to assess the effect of the treatment devices on the electrical activity of the brain compared to sham.
Detailed Description
The Neuro RX Gamma system is a headset which emits pulsed near-infrared energy synchronously or asynchronously through diodes placed on the scalp and inside a nostril.
A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment synchronized, treatment asynchronized or sham (placebo). A dedicated caregiver will apply the device to the subject for 20 minute daily sessions at home, 6 days a week for a total of 12 weeks. The subject and caregiver will be required to return to the clinic for follow-up assessments after 3, 6 and 12 weeks of treatment. Participants will have the choice of opting into a substudy involving the collection of rest EEG recordings during the baseline and weeks 3, 6 and 12 visits.
60 patients will be enrolled in 2 clinical sites in Ontario, Canada.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuro RX Gamma synchronous
Arm Type
Active Comparator
Arm Description
Neuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril.The synchronous device delivers a synchronized pulse frequency of 40 Hz from all LED clusters.
Arm Title
Sham light therapy
Arm Type
Sham Comparator
Arm Description
Sham Neuro RX Gamma device having the same appearance and sound as the Neuro RX Gamma device but does not emit the near-infrared light.
Arm Title
Neuro RX Gamma asynchronous
Arm Type
Active Comparator
Arm Description
Neuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril. The asynchronous device alternatively delivers pulses from the intranasal and anterior LEDs vs. from the posterior LEDS.
Intervention Type
Device
Intervention Name(s)
Neuro RX Gamma synchronous
Intervention Description
Twenty minute treatment, six days per week for 12 weeks
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Twenty minutes, six days per week for 12 weeks with sham device
Intervention Type
Device
Intervention Name(s)
Neuro RX Gamma asynchronous
Intervention Description
Twenty minutes, six days per week for 12 weeks with sham device
Primary Outcome Measure Information:
Title
Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly.
Description
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Device safety according to the number of device-related adverse events
Description
Subjects will be monitored for clinical evidence of device-related adverse events throughout the study.
Time Frame
Baseline to Week 12
Title
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
Description
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
Time Frame
Baseline to Week 3
Title
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
Description
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
Time Frame
Baseline to Week 6
Title
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
Description
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence.
Time Frame
Baseline to Week 3
Title
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
Description
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence.
Time Frame
Baseline to Week 6
Title
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
Description
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence.
Time Frame
Baseline to Week 12
Title
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
Description
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating).
Time Frame
Baseline to Week 3
Title
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
Description
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating).
Time Frame
Baseline to Week 6
Title
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
Description
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating).
Time Frame
Baseline to Week 12
Title
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
Description
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change.
Time Frame
Baseline to Week 3
Title
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
Description
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change.
Time Frame
Baseline to Week 6
Title
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
Description
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change.
Time Frame
Baseline to Week 12
Title
Change in the Electroencephalogram's (EEG) overall power spectral density
Description
The EEG recordings will give insight into the effect on the neural activity of the brain of the Neuro RX Gamma synchronized and Neuro RX Gamma asynchronized compared to sham.
Time Frame
Baseline to Week 12
Other Pre-specified Outcome Measures:
Title
Caregiver reported treatment compliance
Description
Caregivers will document treatment sessions in a logbook to monitor compliance.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age is greater than or equal to 50 years old
Meets the criteria for probable Alzheimer's disease of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months
Mini Mental State Examination (MMSE) score between 0-20 at screening assessment
Severe Impairment Battery score at baseline of ≤90
Outpatient with a reliable caregiver willing to commit to study visits and procedures
Exclusion Criteria:
Current psychiatric or other neurologic disease
Any history of stroke, seizures, light sensitivity (polymorphous light eruption, solar urticaria, persistent light reactivity) or Lyme disease, including those taking photosensitizing medication
Currently undergoing light therapy treatment
Increased skin sensitivity at the treatment site including active herpes simplex in the treatment area, history of keloid formation, or history of retinoid use in the past month
Pregnant or lactating or planning to become pregnant
Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments
Does not speak English at a level necessary for the completion of the assessments.
Currently participating in another clinical research study involving an investigational product.
Has participated in a drug or device study within the last 30 days.
Any condition, such as agitation/aggression, that in the opinion of the investigator would cause the patient to be unable to comply with study procedures
Facility Information:
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B2S7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vielight Neuro RX Gamma - Feasibility Pilot
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