Transcranial Photobiomodulation for Bipolar Depression

A Pilot Clinical Trial for the Efficacy and Safety of Transcranial Photobiomodulation (tPBM) in Improving Symptoms of Bipolar Depression

This study the effectiveness and safety of light therapy device targeted at the brain using a wearable device, the Vielight RX Gamma as a treatment for bipolar depression. Up to forty patients with bipolar disorder will be enrolled into the study and will either receive active treatment with the Vielight RX Gamma or sham (inactive device). They will be administered the devices in clinic 5days/week for 6 weeks. Changes in disease symptoms, cognitive function, pain, quality of life and rest EEG changes will be assessed.

Study Overview

• Status: Not yet recruiting
• Conditions: Bipolar Disorder (BD); Bipolar; Bipolar Disorder Depression
• Intervention / Treatment: Device: Sham Device; Device: Vielight Neuro Rx Gamma

Detailed Description

Photobiomodulation (PBM) refers to the application of low levels of red or near-infrared (NIR) light to either stimulate or inhibit biological cells and tissues involving photochemical mechanisms. Transcranial PBM (tPBM), targeting delivery of light energy to the brain, is associated with increased cerebral blood flow, oxygen availability and consumption, adenoside triphophosphate (ATP) production, and improved mitochondrial activity. More recently, tPBM has demonstrated its value as a treatment for neurological and neurodegenerative conditions. Evidence of mitochondrial dysfunction in patients with BD suggests that PBM may have therapeutic benefits for patients with BD. The primary objective of this study is to confirm the safety and efficacy of using tPBM at 40Hz stimulation in improving symptoms of depression in patients diagnosed with bipolar depression.The study will be a single-blind randomized sham-controlled pilot trial with subjects receiving treatment 5 days/week for 6 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 4X3
      • Providence Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Diagnosis of bipolar depression

  • Montgomery-Asberg Depression Rating Scale (MADRS) of 24 or higher
  • Capable of providing consent
  • Currently inpatient or outpatient
  • Ability to communicate in spoken and written English fluently enough to complete the required study assessments

Exclusion Criteria:

• Currently in manic or mixed episode, as measured by Young Mania Rating Scale (YMRS) more than 8-10

  • Currently psychotic
  • Judged to be at serious and imminent suicidal risk
  • Currently has alcohol or substance use disorder (meeting criteria in the past 1 months)
  • Unstable medical conditions
  • Inability to consent or to complete study procedures
  • Changes in medications or use of augmentative devices and other interventions in the 4 weeks prior to the study
  • Participation in other clinical research trials that may influence primary outcomes or adherence to the proposed study
  • Current pregnancy or intention to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham (inactive Neuro Rx Gamma); Participants assigned to this arm will be administered the sham device in clinic 5 days per week for 6 weeks	Device: Sham Device; Participant assigned to the sham device will be administered the sham device in clinic 5 days/week
Experimental: Neuro Rx Gamma; Treatment with Neuro Rx Gamma	Device: Vielight Neuro Rx Gamma; Participants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	Change in depression symptoms as measured by the Montgomery-Asberg Depression ( Rating Scale (MADRS). Scale is from 0-60, with higher score indicating high depression severity.	Baseline to week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression Scale-Bipolar	Change in Clinical Global Impression Scale-Bipolar (CGI-BP). Scale from 1-7 with a higher means more severe illness.	Change from baseline to week 6
Trails Making Test	Change in score of the Trails Making Test. Scored based on the total time in seconds it takes to complete each part, meaning a lower score is better and a higher score indicates greater cognitive impairment.	Baseline to week 6
N-Back (2-Back)	Change in performance in N-Back (2-back)	Baseline to week 6
World Health Disability Assessment Schedule 2.0 (WHODAS 2.0)	Change in quality of life as measured by the World Health Disability Assessment Schedule 2.0 (WHODAS 2.0). Scores range from 0 to 100, where higher scores indicate greater disability.	Baseline to week 6
Pain Visual Analog Scale	Change in Pain Visual Analog Scale. The scale ranges from 0-100mm, with a higher number indicating more severe pain.	Baseline to week 6
Rest electroencephalography (5min rest, eyes closed)	Change in characteristic features of rest electroencephalography. This is not a scale.	Baseline to week 6
Stanford expectancy scale ratings	Stanford expectancy scale rating. The scale includes six items. Each of the six items is typically rated on an 11-point Likert scale (0-10), ranging from "not at all" to "extremely".	Baseline
Young Mania Rating Scale (YMRS)	Change in Young Mania Rating Scale (YMRS). The Young Mania Rating Scale (YMRS) has a total score range of 0 to 60. A higher value on the YMRS does indicate greater severity of manic symptoms.	Baseline to week 6
Columbia-Suicide Severity Rating Scale (C-SSRS)	Change in Columbia-Suicide Severity Rating Scale. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a multi-part tool and does not have a fixed range, but it generally categorizes risk on a scale of 0-6 for the screener version (0=No Risk, 1-6=Increased Risk) or uses a 2-25 range for intensity of ideation. A higher values on the C-SSRS indicate more severe suicide risk/illness.	Baseline to week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related adverse events	Mean difference in device related adverse events between active and sham groups	Baseline to week 6

Collaborators and Investigators

• Sponsor: Vielight Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 16, 2025
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: bipolar disorder; photobiomodulation; bipolar depression; light therapy; PBM; Vielight
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder
• Other Study ID Numbers: VL-2025-BPD-PILOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No