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.

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.

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