Status:
UNKNOWN
Near-Infrared Laser Stimulation for Various Neurological Conditions
Lead Sponsor:
Neurological Associates of West Los Angeles
Conditions:
Refractory Depression
Anxiety Disorders
Eligibility:
FEMALE
18+ years
Phase:
NA
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, cognit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04489082
Start Date
January 2 2021
End Date
December 1 2024
Last Update
September 28 2022
Active Locations (1)
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1
Neurological Associates of West Los Angele
Santa Monica, California, United States, 90403