← Back to Search

Device

Near-Infrared Laser Stimulation for Neurological Conditions

N/A

Waitlist Available

Led By Sheldon Jordan, M.D.

Research Sponsored by Neurological Associates of West Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Major Depressive Disorder

Failure to remit with 3 anxiolytics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether near-infrared light therapy is safe and effective for treating patients with depression, anxiety, neurodegenerative disease, and traumatic brain injury.

Who is the study for?

This trial is for adults who have not improved after trying at least three treatments for anxiety or depression, have specific types of brain injury or neurodegenerative disease, and show certain changes on advanced brain scans and tests. People with very mild to moderate cognitive decline can join. Those without clear clinical signs of these conditions or who haven't had detailed brain imaging and spinal fluid tests cannot participate.

What is being tested?

The study is testing the safety and effectiveness of using near-infrared laser stimulation as a treatment option for people suffering from refractory depression, various anxiety disorders, neurodegenerative diseases like Alzheimer's, and traumatic brain injuries.

What are the potential side effects?

While the side effects are being studied in this trial, potential risks may include discomfort at the site of stimulation, headache, dizziness or other neurological symptoms due to light exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Major Depressive Disorder.

Select...

I have tried 3 different anxiety medications without success.

Select...

I have tried 3 antidepressants without success.

Select...

I am 18 years old or older.

Select...

I have early-stage memory loss with at least one abnormal brain scan result.

Select...

I have mild to moderate memory or thinking problems.

Select...

I have been diagnosed with Generalized or Acute Anxiety Disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

[Concussion/Traumatic Brain Injury (TBI)] Brief Pain Inventory (BPI)

[Depression (MDD)] Beck Depression Inventory (BDI-II)

Secondary study objectives

[All] Global Rating of Change (GRC)

[Anxiety] Beck Anxiety Inventory (BAI)

[Anxiety] Hamilton Anxiety Rating Scale (HAM-A)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Near Infrared Laser TherapyExperimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met