Bipolar, Bipolar Disorder (BD), Bipolar Disorder Depression
Conditions
Keywords
photobiomodulation, PBM, Vielight, bipolar disorder, bipolar depression, light therapy
Brief summary
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
DEVICEVielight Neuro Rx Gamma
Participants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic
DEVICESham Device
Participant assigned to the sham device will be administered the sham device in clinic 5 days/week
Sponsors
Vielight Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline to week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale-Bipolar | Change from baseline to week 6 | Change in Clinical Global Impression Scale-Bipolar (CGI-BP). Scale from 1-7 with a higher means more severe illness. |
| Trails Making Test | Baseline to week 6 | 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. |
| N-Back (2-Back) | Baseline to week 6 | Change in performance in N-Back (2-back) |
| World Health Disability Assessment Schedule 2.0 (WHODAS 2.0) | Baseline to week 6 | 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. |
| Pain Visual Analog Scale | Baseline to week 6 | Change in Pain Visual Analog Scale. The scale ranges from 0-100mm, with a higher number indicating more severe pain. |
| Rest electroencephalography (5min rest, eyes closed) | Baseline to week 6 | Change in characteristic features of rest electroencephalography. This is not a scale. |
| Stanford expectancy scale ratings | Baseline | 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". |
| Young Mania Rating Scale (YMRS) | Baseline to week 6 | 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. |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline to week 6 | 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. |
Countries
Canada
Outcome results
None listed