Clinical trial NCT04489082: Near-Infrared Laser Stimulation for Various Neurological Conditions
Official title: Use of Near Infrared Laser Stimulation for Treatment of Depression, Anxiety, Neurodegenerative Conditions, and Traumatic Brain Injury/Chronic Traumatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Depression
Anxiety Disorders
Neurodegenerative Diseases
Traumatic Brain Injury
Chronic Traumatic Encephalopathy
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The present study is being undertaken as an open-label study to evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, cognitive impairment due to a neurodegenerative disease (e.g., Alzheimer's), and traumatic brain injury.
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, neurodegenerative disease, and traumatic brain injury.

Detailed description: The present study is being undertaken as an open-label study to evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, cognitive impairment due to a neurodegenerative disease (e.g., Alzheimer's), and traumatic brain injury. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures. The present study can be easily implemented because instruments have been in routine clinical deployment providing for a high degree of availability and reliability. Quality assurance is tightly controlled. The study population is sufficiently broad and the conditions of interest are sufficiently prevalent so that recruitment of subjects is not a limiting factor.

Eligibility criteria: Inclusion Criteria (depression):

* Diagnosis of Major Depressive Disorder
* Score greater than 13 on the Beck Depression Inventory
* Failure to remit with 3 antidepressants
* At least 18 years of age

Inclusion Criteria (anxiety):

* Diagnosis of Generalized or Acute Anxiety Disorder
* Score greater than 22 on the Beck Anxiety Inventory
* Failure to remit with 3 anxiolytics
* At least 18 years of age

Inclusion Criteria (neurodegenerative dementia):

* Cognitive decline with mild cognitive impairment (Clinical Dementia Rating stage 0.5) through moderate dementia (CDR stage 2)
* Lumbar puncture for Abeta 42 and Tau proteins evincing clinical correlation of neurodegenerative disease pathology
* Advanced MRI of the brain including volume measurement of the hippocampus, blood-oxygen level dependent imaging, and arterial spin labeling perfusion scans. On entry, patients will have CDR stage of at least 0.5 and at least one abnormal imaging biomarker.

Inclusion criteria (TBI/CTE):

* Diagnosis of Traumatic Brain Injury or Chronic Traumatic Encephalopathy
* At least 18 years of age

Exclusion Criteria:

* Macular degeneration
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced kidney, pulmonary, cardiac or liver failure
* Advanced terminal illness
* Any active cancer or chemotherapy
* Bone marrow disorder
* Myeloproliferative disorder
* Sickle cell disease
* Primary pulmonary hypertension
* Immunocompromising conditions and/or immunosuppressive therapies
* Any other neoplastic illness or illness characterized by neovascularity
* Subjects unable to give informed consent
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Recent surgery or dental work within 3 months of the scheduled procedure.
* Pregnancy, women who may become pregnant or are breastfeeding

Primary outcomes:
measure: [Depression (MDD)] Beck Depression Inventory (BDI-II)
timeFrame: 6 weeks
measure: [Anxiety] Beck Anxiety Inventory (BAI)
timeFrame: 6 weeks
measure: [Dementia] Quick Dementia Rating Scale (QDRS)
timeFrame: 6 weeks
measure: [Concussion/Traumatic Brain Injury (TBI)] Brief Pain Inventory (BPI)
timeFrame: 6 weeks
measure: [All] Global Rating of Change (GRC)
timeFrame: 6 weeks
Secondary outcomes:
measure: [MDD & TBI] Patient Depression Questionnaire (PDQ-9)
timeFrame: 6 weeks
measure: [MDD & TBI] Patient Depression Questionnaire (PDQ-9)
timeFrame: 4 weeks post last day of treatment
measure: [MDD] Hamilton Depression Rating Scale (HAM-D)
timeFrame: 6 weeks
measure: [MDD] Hamilton Depression Rating Scale (HAM-D)
timeFrame: 4 weeks post last day of treatment
measure: [Anxiety] Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 6 weeks
measure: [Anxiety] Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 4 weeks post last day of treatment
measure: [Dementia] Repeatable Battery Assessment of Neuropsychological Status (RBANS) versions A-D
timeFrame: 6 weeks
measure: [Dementia] Repeatable Battery Assessment of Neuropsychological Status (RBANS) versions A-D
timeFrame: 4 weeks post last day of treatment
measure: [Dementia] Montreal Cognitive Assessment (MoCA) versions 7.1-7.3
timeFrame: 6 weeks
measure: [Dementia] Montreal Cognitive Assessment (MoCA) versions 7.1-7.3
timeFrame: 4 weeks post last day of treatment
measure: [MDD] Beck Depression Inventory (BDI-II)
timeFrame: 4 weeks post last day of treatment
measure: [Anxiety] Beck Anxiety Inventory (BAI)
timeFrame: 4 weeks post last day of treatment
measure: [Dementia] Quick Dementia Rating Scale (QDRS)
timeFrame: 4 weeks post last day of treatment
measure: [TBI] Brief Pain Inventory (BPI)
timeFrame: 4 weeks post last day of treatment
measure: [All] Global Rating of Change (GRC)
timeFrame: 4 weeks post last day of treatment
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West Los Angele
state: California
Study officials:
affiliation: Neurological Associates of West Los Angeles
name: Sheldon Jordan, M.D.
role: PRINCIPAL_INVESTIGATOR
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