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 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.

Are You a Good Fit for This Trial?

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
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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

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+