NCT04489082

Near-Infrared Laser Stimulation for Various Neurological Conditions

Use of Near Infrared Laser Stimulation for Treatment of Depression, Anxiety, Neurodegenerative Conditions, and Traumatic Brain Injury/Chronic Traumatic Encephalopathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory Depression
• Anxiety Disorders
• Neurodegenerative Diseases
• Traumatic Brain Injury
• Chronic Traumatic Encephalopathy

Interventions

Type	Name	Description
DEVICE	Near Infrared Laser Stimulation	10 minutes of transcranial near infrared laser stimulation

Timeline

• Start date: 2021-01-02
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2020-07-28
• Last updated: 2022-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study