Menu
Not yet recruiting NCT07510646

Transcranial Photobiomodulation for Bipolar Depression

No phase Interventional Bipolar Bipolar Disorder (BD) Bipolar Disorder Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vielight Neuro Rx Gamma, Sham Device.
Who it may be relevant to
Registry conditions: Bipolar, Bipolar Disorder (BD), Bipolar Disorder Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Device Vielight Neuro Rx Gamma
    Participants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic
  • Device Sham Device
    Participant assigned to the sham device will be administered the sham device in clinic 5 days/week

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: Baseline to week 6]
Secondary outcome measures (9)
  • Clinical Global Impression Scale-Bipolar [Time frame: Change from baseline to week 6]
  • Trails Making Test [Time frame: Baseline to week 6]
  • N-Back (2-Back) [Time frame: Baseline to week 6]
  • World Health Disability Assessment Schedule 2.0 (WHODAS 2.0) [Time frame: Baseline to week 6]
  • Pain Visual Analog Scale [Time frame: Baseline to week 6]
  • Rest electroencephalography (5min rest, eyes closed) [Time frame: Baseline to week 6]
  • Stanford expectancy scale ratings [Time frame: Baseline]
  • Young Mania Rating Scale (YMRS) [Time frame: Baseline to week 6]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Baseline to week 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Providence Care Hospital — Kingston

Identifiers

NCT: NCT07510646 · VL-2025-BPD-PILOT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗