Transcranial Photobiomodulation for the Treatment of Pediatric Depression

March 12, 2024 updated by: Carrie Vaudreuil, Massachusetts General Hospital

Detailed Protocol: Evaluation of Transcranial Photobiomodulation for the Treatment of Pediatric Depression: An Open-Label Pilot Study

An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving symptoms of depression in youth.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Pediatric depression is a prevalent and morbid disorder estimated to affect up to 12% of youth in the United States by the time they reach adolescence. Recent research has documented that even minor symptoms of depression as captured through the Child Behavior Checklist (CBCL) Anxiety/Depression scale are strongly associated with the subsequent development of major depression. While treatments with antidepressants and psychotherapy are available, antidepressants can be associated with adverse effects including manic activation and psychosocial interventions are costly and not wide available. This state of affairs supports the search for safe and effective alternative treatments.

One such opportunity is transcranial LED therapy, also known as transcranial photobiomodulation (tPBM). The treatment consists of exposing the frontal brain to the tPBM bilaterally, which is hypothesized to enhance adenosine triphosphate (ATP) production in depressed subjects. tPBM is a non-ionizing electromagnetic wave. It is invisible, penetrates the skin and skull into brain tissue, is non-invasive, is minimally dissipated as thermal energy, and is mainly absorbed by specific chromophores. The benefits of tPBM are wavelength specific. A mitochondrial enzyme, the cytochrome c oxidase, is the primary chromophore for the tPBM, with a wavelength around 830 nm. The energy absorbed by the cytochrome c oxidase leads to increased ATP production through the respiratory chain. Ultimately, the increased ATP is thought to lead to increased energy metabolism for the cell, and it is hypothesized that a signaling cascade is activated promoting cellular plasticity and cytoprotection. These properties of the tPBM have led to novel therapeutic applications in psychiatry. A preliminary open label study in 10 depressed subjects has shown that the tPBM was safe, effective and well tolerated in depressed adults. Further research confirmed these findings and shown tPBM therapy to be a promising intervention for adults with MDD. However, whether this non-invasive intervention may be safe and effective in pediatric depression remains unknown.

To this end the investigators propose a pilot study is to evaluate whether tPBM is safe and effective in the treatment of pediatric depression. This study will enroll 30 youth of both sexes 6-17 years with active symptoms of depression as assessed through elevated scores on the CBCL Anxiety/depression scale. Based on the adult literature, investigators hypothesize that it will be safe and effective in this population.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female children aged 6- 17 years
  • A CBCL T score of ≥ 60 on the Anxious/Depressed scale
  • Current treatment with a psychotropic medication or psychological treatment will be allowed provided that no medication or psychological treatment changes occur during the study

Exclusion Criteria:

  • Clinically unstable current psychiatric conditions judged to be a serious safety risk to self or others such as active suicidal ideation, psychosis or mania
  • Subjects with an unstable medical condition that requires clinical attention
  • The subject has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo).
  • Inadequate command of the English language
  • History of neurological injury or disease
  • Impaired intellectual capacity (clinically determined)
  • The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve).
  • Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer
  • Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Photobiomodulation
Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.
Device: Transcranial Photobiomodulation
Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.
Other Names:
  • Niraxx G1 Headband

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy-Major Depressive Disorder (Clinical Global Impression - Major Depressive Disorder)
Time Frame: Baseline to Week 8
To evaluate the efficacy of transcranial photobiomodulation in treatment of depression. The Clinical Global Impression Scale rates symptoms of depression from a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients), with higher scores on this scale indicating a worse outcome.
Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (The Transcranial Photobiomodulation Self-Report Questionnaire)
Time Frame: Baseline to Week 8
To assess the safety of transcranial photobiomodulation for treatment of depression. The Transcranial Photobiomodulation (tPBM) Self-Report Questionnaire rates the patient's comfort/discomfort with the tPBM on a scale of 0 (not discomfort) to 5 (extreme discomfort), with higher scores on this scale indicating a worse outcome.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Carrie Vaudreuil, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2020

Primary Completion (Estimated)

November 1, 2022

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P002694

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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