Near-Infrared Laser Stimulation for Various Neurological Conditions

Neurological Associates of West Los Angeles

Status: Invitation-only

Conditions: Traumatic Brain Injury; Neurodegenerative Diseases; Chronic Traumatic Encephalopathy; Anxiety Disorders; Refractory Depression

Treatments: Device: Near Infrared Laser Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04489082

20192916

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Near Infrared Laser Therapy

Experimental group

Description:

On the days of each near-infrared therapy session, patients will undergo 10 minutes of transcranial infrared laser stimulation. The laser dose for all conditions will be a 3.4 W continuous laser wave, at a 1064 wavelength, with irradiance (power density) at 250 milli-Watts/cm2. All groups will have treatment once a week (10 minutes per session) for 5-6 weeks. For Alzheimer's, the site targeted will be the right prefrontal cortex. Parkinson's patients will have laser delivered to the brain stem, bilateral temporal lobes. TBI/CTE patients will have the laser stimulation site dependent on location of injury. Patients with depression/anxiety will have laser stimulation applied to the prefrontal area of the head.

Treatment:

Device: Near Infrared Laser Stimulation