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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

Study 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.Check my eligibility

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.See study design

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

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I have been diagnosed with Major Depressive Disorder.

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I have tried 3 different anxiety medications without success.

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I have tried 3 antidepressants without success.

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I am 18 years old or older.

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

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I have mild to moderate memory or thinking problems.

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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

[All] Global Rating of Change (GRC)

[Anxiety] Beck Anxiety Inventory (BAI)

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

+7 more

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

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Who is running the clinical trial?

Neurological Associates of West Los AngelesLead Sponsor

25 Previous Clinical Trials

3,560 Total Patients Enrolled

Sheldon Jordan, M.D.Principal InvestigatorNeurological Associates of West Los Angeles

4 Previous Clinical Trials

515 Total Patients Enrolled

Media Library

Near Infrared Laser Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04489082 — N/A

Neurodegenerative Disease Clinical Trial 2023: Near Infrared Laser Stimulation Highlights & Side Effects. Trial Name: NCT04489082 — N/A

Near Infrared Laser Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04489082 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration for this research project currently open?

"According to the clinicaltrials.gov data, this medical trial is no longer accepting patients as recruitment was halted on September 26th 2022. However, there are still 1,928 other studies actively recruiting at this moment in time."

Answered by AI

What objectives are the researchers seeking to accomplish with this investigation?

"This trial, which is monitored over a period of 6 weeks, seeks to measure its primary outcome using the Beck Depression Inventory (BDI-II). Secondary objectives include evaluating cognitive status with The Montreal Cognitive Assessment (MoCA), understanding pain intensity and interference levels with the Brief Pain Inventory (BPI), and assessing dementia severity through the Quick Dementia Rating Scale (QDRS)."

Answered by AI