Transcranial Photobiomodulation for Bipolar Depression

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Baseline to week 6]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• • 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Providence Care Hospital — Kingston

Идентификаторы

NCT: NCT07510646 · VL-2025-BPD-PILOT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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