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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham (inactive Neuro Rx Gamma) | Sham Comparator | Participants assigned to this arm will be administered the sham device in clinic 5 days per week for 6 weeks |
|
| Neuro Rx Gamma | Experimental | Treatment with Neuro Rx Gamma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vielight Neuro Rx Gamma | Device | Participants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to week 6 |
| Trails Making Test |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related adverse events | Mean difference in device related adverse events between active and sham groups | Baseline to week 6 |
Inclusion Criteria:
• Diagnosis of bipolar depression
Exclusion Criteria:
Currently in manic or mixed episode, as measured by Young Mania Rating Scale (YMRS) more than 8-10
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Care Hospital | Kingston | Ontario | K7L 4X3 | Canada |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Sham Device | Device | Participant assigned to the sham device will be administered the sham device in clinic 5 days/week |
|
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.
| Baseline to week 6 |
| N-Back (2-Back) | Change in performance in N-Back (2-back) | 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. | 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. | Baseline to week 6 |
| Rest electroencephalography (5min rest, eyes closed) | Change in characteristic features of rest electroencephalography. This is not a scale. | 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". | 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. | 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. | Baseline to week 6 |