BipolarNCT07510646
Transcranial Photobiomodulation for Bipolar Depression
A study testing Vielight Neuro Rx Gamma in people with Bipolar and Bipolar Disorder (BD), run by Vielight Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar, Bipolar Disorder (BD), Bipolar Disorder Depression
- What is being tested?
- Vielight Neuro Rx Gamma
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar, Bipolar Disorder (BD), Bipolar Disorder Depression
- Being tested
- Vielight Neuro Rx Gamma, Sham Device
- Keywords
- photobiomodulation, PBM, Vielight, bipolar disorder, bipolar depression, light therapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vielight Neuro Rx GammaDevice
Participants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic
Sham DeviceDevice
Participant assigned to the sham device will be administered the sham device in clinic 5 days/week
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Sham Device |
| Neuro Rx Gamma | Experimental | Treatment with Neuro Rx Gamma Receives: Device: Vielight Neuro Rx Gamma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week 6
Secondary outcomes (9)
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.
Measured: 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.
Measured: Baseline to week 6
N-Back (2-Back)
Change in performance in N-Back (2-back)
Measured: 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.
Measured: 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.
Measured: Baseline to week 6
Rest electroencephalography (5min rest, eyes closed)
Change in characteristic features of rest electroencephalography. This is not a scale.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: Baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BipolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vielight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510646
- Sponsor's protocol ID
- VL-2025-BPD-PILOT
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial for the Efficacy and Safety of Transcranial Photobiomodulation (tPBM) in Improving Symptoms of Bipolar Depression
- ClinicalTrials.gov ID
- NCT07510646
- Acronym / sponsor ID
- VL-2025-BPD-PILOT
- Conditions
- Bipolar, Bipolar Disorder (BD), Bipolar Disorder Depression
- Keywords
- photobiomodulation, PBM, Vielight, bipolar disorder, bipolar depression, light therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vielight Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham (inactive Neuro Rx Gamma) | Sham comparator | Device: Sham DeviceParticipants assigned to this arm will be administered the sham device in clinic 5 days per week for 6 weeks |
| Neuro Rx Gamma | Experimental | Device: Vielight Neuro Rx GammaTreatment with Neuro Rx Gamma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Diagnosis of bipolar depression
Key exclusion criteria (9 listed)
- Currently in manic or mixed episode, as measured by Young Mania Rating Scale (YMRS) more than 8-10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vielight Neuro Rx GammaParticipants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic | Device | Neuro Rx Gamma |
| Sham DeviceParticipant assigned to the sham device will be administered the sham device in clinic 5 days/week | Device | Sham (inactive Neuro Rx Gamma) |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 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.
9 secondary outcomes
Clinical Global Impression Scale-Bipolar
Time frame: Change from baseline to week 6
Trails Making Test
Time frame: Baseline to week 6
N-Back (2-Back)
Time frame: Baseline to week 6
World Health Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline to week 6
Pain Visual Analog Scale
Time frame: Baseline to week 6
Rest electroencephalography (5min rest, eyes closed)
Time frame: Baseline to week 6
Stanford expectancy scale ratings
Time frame: Baseline
Young Mania Rating Scale (YMRS)
Time frame: Baseline to week 6
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline to week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vielight Neuro Rx Gamma in people with Bipolar and Bipolar Disorder (BD), run by Vielight Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Baseline to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.