NEUROMODULATION DEVICE
Overview
ProlivRx is a prescription-only neuromodulation device approved by the U.S. Food and Drug Administration (FDA) as an adjunctive (add-on) treatment for adults with major depressive disorder (MDD) who have not had satisfactory improvement after trying at least one antidepressant medication. To be eligible, a person must have MDD with inadequate response to antidepressant medications.
ProlivRx is classified as a neuromodulation device. It uses a technology called external combined occipital and trigeminal afferent stimulation. It works by delivering gentle electrical pulses to specific nerve branches in the scalp (occipital and trigeminal nerves), which are involved in mood regulation. Scientists believe that stimulating these neural pathways helps balance the brain circuits associated with depression symptoms.
How is it used?
ProlivRx is used at home, following a prescription and initial training by a healthcare provider. The treatment is self-administered with a wearable headset device, which delivers the electrical stimulation to targeted areas of the scalp. In clinical trials, participants used the device for 40 minutes per session, twice daily, five to seven days per week during the initial eight-week phase. For those who achieved remission, a less frequent maintenance schedule was followed (three to four times per week). The device should be used exactly as prescribed by a healthcare provider, with continued medical oversight.
Side effects
Common side effects of ProlivRx include headache, discomfort at the application site, skin irritation (discoloration or itching where the device is placed), burning or stinging sensations on the scalp, and mild pain or pressure.
Rare but serious side effects may include worsening depression symptoms.
For more information about this treatment, visit:
A Novel Home-Based, Combined Occipital and Trigeminal Afferent Stimulation Therapy for Major Depressive Disorder: Efficacy and Safety Results From a Double-Blind Multicenter Randomized Sham-Controlled Study — Brain Stimulation
Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants — NeuroRelief
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