Transcranial Photobiomodulation for Bipolar Depression

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vielight Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a light therapy device called the Vielight Neuro Rx Gamma to determine its effectiveness for people with bipolar depression. The device targets the brain, and the study will examine changes in symptoms, thinking skills, pain, and overall quality of life. Participants will use either the active device or a sham (inactive) device in a clinic setting for six weeks. Individuals with stable bipolar depression who can communicate in English are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance treatment options for bipolar depression.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop your current medications, but it mentions that changes in medications in the 4 weeks before the study are not allowed. It's best to discuss your specific situation with the study team.

What prior data suggests that this light therapy device is safe for treating bipolar depression?

Research has shown that the Vielight Neuro Rx Gamma device is generally safe for use. In one study with 20 healthy participants, the device was used without any major safety issues. Another study examined its use for memory problems and found it to be safe, with no significant side effects reported.

These findings suggest that the device is safe, as previous studies have not commonly noted serious side effects. The device uses light therapy aimed at the brain to potentially help with various conditions, including depression. While the current trial for bipolar depression is ongoing, past research provides a positive outlook on its safety.12345

Why are researchers excited about this trial?

Most treatments for bipolar depression rely on medications like mood stabilizers and antipsychotics, which can take weeks to show effects and often come with significant side effects. Vielight Neuro Rx Gamma is unique because it uses transcranial photobiomodulation, a non-invasive method that delivers light to the brain to potentially improve mood and cognitive function. Researchers are excited about this treatment because it offers a novel mechanism of action, targeting brain activity with light rather than chemicals, which could mean fewer side effects and faster results. Additionally, this approach is intriguing because it represents a shift towards using technology to manage mental health conditions, offering new hope for those who might not respond well to traditional medications.

What evidence suggests that the Vielight Neuro Rx Gamma is effective for bipolar depression?

Research suggests that the Vielight Neuro RX Gamma device, which participants in this trial may receive, might help ease symptoms of bipolar depression. One study showed that using this device improved sleep and reduced anxiety in patients after 12 weeks. The device uses near-infrared light to stimulate brain cells and decrease inflammation linked to mood disorders. While light therapy appears promising for treating bipolar depression, more research is needed to confirm these effects. Early results are encouraging, but further studies are necessary to fully understand its benefits.23678

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with bipolar depression who can speak and write English, are able to give consent, and have a certain level of depressive symptoms. Both inpatients and outpatients may join.

Inclusion Criteria

I have been diagnosed with bipolar depression.
I am able to understand and agree to participate in the study.
* Currently inpatient or outpatient
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the active Neuro Rx Gamma device or a sham device in clinic 5 days per week for 6 weeks

6 weeks
5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Vielight Neuro Rx Gamma

Trial Overview

The study tests a wearable light therapy device (Vielight Neuro Rx Gamma) aimed at the brain versus an inactive sham device. Participants use the devices in clinic five days a week for six weeks to see if it helps with bipolar depression.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Neuro Rx GammaExperimental Treatment1 Intervention
Group II: Sham (inactive Neuro Rx Gamma)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vielight Inc.

Lead Sponsor

Trials
5
Recruited
640+

Citations

Transcranial Photobiomodulation for 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 ...

A Study Evaluating the Efficacy of the Vielight Neuro RX ...

The Vielight Neuro RX Gamma emitting NIR might reduce inflammatory markers relevant to COVID-19 and since it pulses at 40 Hz can activate the non-inflammatory ...

A Scientific Report Sheds Light on Unanswered Questions

In this randomized double-blind study, the Vielight Neuro Gamma was applied to 20 human subjects with healthy brains. Using near infrared light ...

Vielight Depression Study

A research study evaluating the efficacy of Vielight Neuro devices in the treatment of Major Depressive Disorder.

Photobiomodulation and Neuro Research: Clinical Studies

After 12 weeks of treatment with the Vielight Neuro Gamma, patients showed significant cognitive improvements, including better sleep and reduced anxiety. In ...

Photobiomodulation and Neuro Research: Clinical Studies

Explore 25+ published clinical trials and peer-reviewed studies featuring Vielight PBM technology across brain health, TBI, Long COVID, and systemic ...

Transcranial photobiomodulation for the treatment of ... - PMC

Photobiomodulation sessions. Patients underwent an average of 10.8 ± 1.7 sessions of tPBM with the Vielight Neuro Duo 4® device (Gamma mode).

A Scientific Report Sheds Light on Unanswered Questions

In this randomized double-blind study, the Vielight Neuro Gamma was applied to 20 human subjects with healthy brains. Using near infrared light ...