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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Participants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic
Participant assigned to the sham device will be administered the sham device in clinic 5 days/week
Providence Care Hospital
Kingston, Ontario, Canada
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.
Time frame: Baseline to week 6
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.
Time frame: 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.
Time frame: Baseline to week 6
N-Back (2-Back)
Change in performance in N-Back (2-back)
Time frame: 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.
Time frame: 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.
Time frame: Baseline to week 6
Rest electroencephalography (5min rest, eyes closed)
Change in characteristic features of rest electroencephalography. This is not a scale.
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Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: Baseline to week 6