What is Proliv®Rx?
Proliv is a wearable electrical neuromodulation headset used at home under the supervision of a prescribing clinician.
But it is not tDCS and it is not home TMS.
Instead of applying electrical current across the prefrontal cortex of the brain, Proliv stimulates branches of two sets of nerves around the head:
the trigeminal nerves across the forehead
the greater occipital nerves toward the back of the head
Those nerves carry signals up into the brainstem and networks involved in regulating mood.
The technical term is external Combined Occipital and Trigeminal Afferent Stimulation, or eCOT-AS.
No surgery. No anesthesia. No seizure risk. And unlike TMS, you do not need to travel to a clinic for every session.
How much does Proliv cost?
This is changing quickly because the device is very new.
As of November 2026, Neurolief has described an early cash-pay pathway of approximately $2,500 for a 16-week treatment program.
The company, rather than my practice, handles the device, payment, shipping, onboarding, and technical support.
I don't receive payment from Neurolief for prescribing Proliv, and the treatment cost is paid directly to Neurolief rather than to my practice.
Commercial insurance coverage is still evolving. Neurolief is also pursuing individual insurance authorizations in some cases rather than requiring the prescribing psychiatrist to manage that process directly.
I would currently treat insurance reimbursement as possible, not predictable.
If cost is a major factor in your decision, we can compare Proliv with Flow, TMS coverage through your insurance, medication options, and simply waiting while coverage pathways mature.
Pricing and access are changing rapidly, so I will confirm the current terms before you make a treatment decision.
Do I buy the device?
Current Proliv programs are structured around a course of treatment, rather than simply buying a headset and using it indefinitely.
The device is shipped to you after it is prescribed and activated for your treatment program.
At the end of the prescribed course, we assess what happened and decide whether further treatment makes sense.
Long-term maintenance treatment is an area the company is continuing to develop.
That is another important unknown right now: we do not yet have strong data telling us how durable improvement is after treatment stops or exactly what the best maintenance strategy should be.
Proliv®Rx for Depression
At-home neuromodulation after antidepressants haven’t worked well or haven’t worked enough.
Proliv®Rx is a new FDA-approved, prescription-only neuromodulation treatment that you use at home.
Unlike Flow tDCS, which is FDA-approved for people who are not considered treatment refractory to medication, Proliv was specifically studied and approved as an add-on treatment for adults with major depression who have already tried at least one antidepressant without enough improvement.
As of November 2026, I am able to offer Proliv®Rx to appropriate patients in California, alongside medication, psychotherapy and referrals for treatments such as TMS, Flow tDCS, Spravato, ketamine (pharmaceutical or psychotherapy-focused), light therapy, or other interventional options when those make more sense.
Interested in at-home neuromodulation?
Who is Proliv for?
The FDA indication is fairly specific:
Proliv is approved as an adjunctive treatment for major depressive disorder in adults who have not had satisfactory improvement from at least one previous antidepressant medication.
In other words -
Proliv may be worth considering if:
You have major depressive disorder.
At least one antidepressant hasn’t worked well enough.
You want another option beyond simply trying medication after medication.
You are interested in neuromodulation but daily travel for TMS would be difficult.
You can realistically commit to a fairly intensive at-home treatment schedule.
You and your psychiatrist decide it makes sense alongside your existing treatment.
Importantly, Proliv is currently approved as an add-on treatment, not as a replacement for your existing antidepressant treatment.
It is also not currently FDA-approved for bipolar depression.
Does Proliv actually work?
This is new treatment territory, so I think the useful answer is: there is encouraging randomized controlled evidence, but I would not oversell it.
This is all very new!
The pivotal MOOD study included only 124 adults with major depression who had already failed to respond adequately to antidepressant medication.
For the first eight weeks, participants were randomized to active Proliv or a sham stimulation (the device is the same, but the stimulation is off).
At eight weeks:
Depression scores improved by an average of 8.6 points with active treatment versus 6.0 points with sham treatment (a 2.6 point advantage).
And:
21.3% of people receiving active treatment reached remission, compared with 6.0% receiving sham treatment.
After the blinded portion ended, participants continued with active treatment. By week 16, about 32% were in remission.
That later improvement is interesting, but there is an important caveat: after week eight, there was no longer a blinded placebo comparison. We therefore cannot assume that all of the additional improvement from weeks 8 to 16 came from the device itself - but also an expectation effect may have contributed (but it is also a real biological process!).
The FDA itself noted a moderate level of uncertainty about the magnitude of benefit, including uncertainty about how clinically meaningful the difference between active and sham treatment is, how well blinding held up, and how durable the benefit remains after treatment ends.
So my interpretation is not:
“This works for everyone.”
It is closer to:
This is a legitimately studied, low-burden-from-a-medication-standpoint option with a favorable safety profile, and its evidence is unusually relevant to people who have already tried antidepressants. For the right person, that makes it worth considering.
What does treatment actually involve?
This is one place where Proliv asks quite a bit of you.
After an introductory ramp-up period for one week, the standard treatment involves:
Two 40-minute sessions per day
That is about 80 minutes of treatment per day. I recommend blocking off one hour in the morning and one hour in the evening.
You can generally do quiet activities during a session, such as reading, watching television, or working on something that does not require you to drive or operate equipment.
The manufacturer generally recommends separating the two sessions rather than doing them immediately back-to-back.
You wear the headset at home while the app guides treatment.
The app checks that the electrodes have good contact before stimulation begins.
Treatment intensity increases gradually during the initial acclimation period rather than starting at full intensity on day one.
Programs can be prescribed for 8 or 16 weeks.
The app also tracks your treatments and periodically asks you to complete a depression questionnaire so that we can monitor whether things are actually changing rather than relying only on memory.
How will we know if it is working?
I do not want “I think maybe I feel a little better?” to be our only outcome measure.
The Proliv app tracks treatment adherence and asks you to complete a standardized depression questionnaire every two weeks.
We can combine that with the things that matter more in real life:
Are you getting out of bed more easily?
Are you functioning better at work?
Are you more interested in other people?
Are you enjoying anything again?
Is the hopelessness changing?
Are you doing more of the things that make your life feel like yours?
Numbers are useful.
Your life is the outcome.
What are the side effects?
Proliv was generally well tolerated in the clinical trial.
Potential effects include:
tingling, stinging, itching, or burning sensations around the electrodes
scalp numbness
pressure or discomfort
temporary redness or skin irritation
headache or migraine
dizziness
fatigue or sleepiness
changes in sleep
Most device-related adverse effects in the clinical trial were mild to moderate.
As with other treatments for depression, worsening depression, suicidal thoughts, and mania are also listed as potential adverse events and require clinical monitoring.
Who should not use Proliv?
Proliv has several important contraindications.
It should not be used in people with:
a history of intracranial surgery
a recent traumatic brain injury
metal implants or shrapnel in the head, other than dental implants
an implanted electronic or neurostimulation device in the head
a cardiac pacemaker
an implanted or wearable defibrillator
significant skin lesions, scars, or inflammation where the electrodes need to sit
There are additional precautions for pregnancy, epilepsy, heart disease, worsening depression, and suicidality.
We would review the full safety criteria before prescribing it.
Proliv vs Flow: what’s the difference?
They are both prescription devices you can use at home for depression, but they work differently and were studied in different populations.
Flow tDCS
How it works:
Applies transcranial direct current stimulation to the prefrontal cortex.
FDA population:
Adults 18+ with moderate to severe major depression who are not considered treatment refractory to medication.
Can it be used without an antidepressant?
Yes. Flow is approved as monotherapy or as an add-on.
Treatment burden:
Generally less time-intensive than Proliv.
Where I think it may fit:
Earlier in the depression treatment course, particularly when someone wants a non-medication option or has not gone through multiple failed treatments.
Proliv®Rx
How it works:
Stimulates the trigeminal and occipital nerve pathways rather than directly applying current across the prefrontal cortex.
FDA population:
Adults with major depression who have already had inadequate improvement from at least one antidepressant.
Can it be used without an antidepressant?
Not according to its FDA indication. It is an adjunctive treatment.
Treatment burden:
Two 40-minute treatments per day during the active treatment course.
Where I think it may fit:
Someone whose depression has persisted despite medication and who wants to consider neuromodulation but would prefer an at-home option before, instead of, or when unable to access an intensive in-clinic intervention.
Is Proliv better than Flow?
We do not know.
There has not been a head-to-head trial comparing them.
What I find compelling about Proliv is not evidence that it is stronger. It is that the people studied in the Proliv trial had already failed antidepressant treatment.
If that describes you, the Proliv data may therefore be more relevant to your situation than the Flow trial data.
That is not the same as proving that Proliv will work better.
What about TMS?
TMS remains a much more established treatment for treatment-resistant depression, with decades of research, multiple devices and protocols, and substantially more clinical experience.
If you are an appropriate TMS candidate and have good insurance coverage and practical access to a high-quality TMS program, I would not automatically choose a newer home device instead.
But TMS can also require:
frequent trips to a clinic
substantial time away from work or family
finding a good local treatment center
insurance authorization and deductibles
For some people, those barriers are trivial.
For others, they are the reason TMS never happens.
Proliv creates another rung on the ladder between “try another medication” and “go to a specialty clinic for daily neuromodulation.”
That is probably where I find it most interesting.
Can I use Proliv at the same time as TMS or Spravato?
Right now, we do not have good clinical evidence on combining Proliv simultaneously with TMS or Spravato.
That does not mean the combinations have been shown to be dangerous.
It means they have not been adequately studied.
In most cases I would rather sequence treatments thoughtfully and be able to tell what is actually helping than pile several forms of neuromodulation on top of one another without evidence that the combination adds benefit.
Can Proliv treat bipolar depression?
Not currently.
The FDA indication is for major depressive disorder, not bipolar depression.
That is an important distinction because treatments that affect mood circuitry can have different implications in bipolar disorder, including the possibility of treatment-emergent mania or hypomania.
If you have bipolar disorder, I would consider other evidence-based treatment options rather than treating Proliv as interchangeable with its use in unipolar depression.
How it works in my practice
Proliv is prescription-only, so the first step is a psychiatric evaluation to determine whether it actually fits your diagnosis, treatment history, medical history, medications, goals, and alternatives. Prescriptions for Proliv are only available to people who are active patients in my practice, meaning I am their main psychiatrist, and we meet at least once every 3 months.
If it looks appropriate:
We decide together whether Proliv makes sense compared with Flow, medication changes, TMS, Spravato, psychotherapy, or simply giving your current treatment more time.
I submit the Proliv prescription.
Neurolief coordinates the device, payment or insurance process, shipping, app setup, and onboarding.
You complete treatment at home.
We monitor symptoms, function, tolerability, and whether continuing still makes sense.
This is not a gadget I want people using just because it is new.
It is another treatment option.
My job is to help you figure out whether it is actually the right one for you.
What does the ProLiv device feel like?
What can I do while wearing it?
What are common side effects?
Most people feel tingling, prickling, itching, or sometimes mild stinging around the electrodes on the forehead and back of the head. Some people also notice pressure or temporary scalp numbness as the session goes on.
The stimulation ramps up gradually, and you increase it only to the highest level that still feels comfortable. The first week is specifically designed as a ramp-up period, gradually increasing both the treatment time and intensity before you reach the regular 40-minute sessions.
Once you finish the first-week ramp-up, Proliv is used for two 40-minute sessions each day, ideally separated by 4 hours at minimum to give your skin a break. I recommend planning a one-hour block in the morning and one in the evening.
You do not need to sit completely still. You can read, watch TV, answer email, work on your computer, or do other light activities around the house while wearing it. The device works with an app on your phone, which also tracks your sessions and periodically checks in on your depression symptoms.
Don’t use it while driving, operating machinery, showering or bathing, or doing anything where you need to be fully alert and focused.
The main device-related side effect is headache. In the original trial, several people developed headaches when the stimulation intensity was increased too quickly, which led to a change in the ramp-up instructions. The current program increases stimulation more gradually to improve tolerability.
Other possible effects include tingling, stinging, itching or burning at the stimulation sites, pressure or discomfort, temporary scalp numbness, skin redness or irritation, dizziness, fatigue or sleepiness. Most device-related effects seen in the clinical studies were mild to moderate and temporary.
As with any depression treatment, worsening depression, suicidal thoughts, or symptoms of mania are important reasons to contact your psychiatrist promptly.
Why do this with a psychiatrist
Deciding whether it's for you
Proliv fits a fairly specific person: someone with major depression who hasn’t improved enough with at least one antidepressant, and who can realistically take on two treatment sessions a day.
Part of my job is helping you decide whether that makes sense, or whether the better next step is TMS, Spravato, a medication change, psychotherapy, or something with no device in it at all.
Track Helpfulness
The Proliv app tracks your treatment sessions and asks you to complete a depression questionnaire every two weeks.
Right now, those reports aren’t automatically sent to me, so you’ll share them with me and we’ll look at them together alongside how you’re actually functioning and feeling. The point is not just to finish the treatment course. It’s to know whether it’s doing anything useful.
One part of the plan
A headset isn’t a treatment plan. Proliv is FDA-approved as an add-on treatment, and it sits alongside whatever else we’re building: medication, therapy, sleep, relationships, movement, and the parts of your life a device can’t reach.
We’ll also decide up front what happens if it doesn’t help, so that eight or sixteen weeks of no meaningful change becomes information, rather than a stuck point.
Frequently asked questions
Does Proliv actually work? Yes, modestly, based on one good randomized trial in a population I find clinically relevant. In the study supporting FDA approval, participants had major depression and had already failed to improve adequately with antidepressants. After eight weeks, depression scores improved by 8.6 points with active Proliv versus 6.0 points with sham, a 2.6-point difference. Remission occurred in 21.3% with Proliv versus 6.0% with sham. The FDA described the probable benefit as modest and noted a “moderate level of uncertainty of benefit.” People who continued active treatment improved further through week 16, with about 32% reaching remission, but that portion of the study was no longer placebo-controlled, so we can’t assume all of the later improvement was caused by the device. It’s a real treatment with promising data in people who have already failed medication, but it is also very new.
Is Proliv safe? So far, the safety profile looks fairly favorable. The main device risk is headache, with other possible effects including tingling, stinging, itching or burning at the stimulation sites, scalp numbness, pressure or discomfort, skin irritation, dizziness, fatigue or sleepiness. Most adverse effects in the clinical trial were mild to moderate and temporary. Early in the trial, several participants developed headaches when they increased the stimulation too aggressively, which led the company to revise the ramp-up instructions. The current program builds intensity more gradually. It should not be used with certain implanted electronic devices or metal in the head, recent traumatic brain injury, prior intracranial surgery, or skin problems where the electrodes sit.
Is Proliv FDA approved? Yes. The FDA granted premarket approval (PMA P250010) on December 31, 2025. It is approved as an add-on treatment for adults with major depressive disorder who have not improved adequately with at least one previous antidepressant medication, for use at home or in a clinic. This distinction is important: unlike Flow, Proliv was specifically studied in people whose depression had already not responded adequately to medication.
How much does Proliv cost? As of November 2026, Neurolief is offering an early cash-pay program of approximately $2,500 for a 16-week treatment course. Payment goes to Neurolief rather than to my practice, and the company handles the device, shipping, onboarding, app support, and technical support. Because Proliv is so new, I expect pricing and access options to evolve, so we would confirm the current cost before you commit.
Does insurance cover Proliv? Maybe, but I would not count on it yet. Neurolief is currently pursuing individual authorization agreements with some commercial insurers and handles much of that process directly. They have begun obtaining some individual approvals, but this is a very new coverage pathway and there is not yet predictable broad commercial coverage. If you want to try insurance, we can submit the clinical information they need and let their access team pursue it. Cash pay remains the more predictable option right now.
Is Proliv the same as TMS? No. TMS uses a powerful magnetic field to stimulate cortical brain tissue directly and requires specialized equipment, precise targeting, and repeated clinic visits. Proliv uses electrical stimulation of branches of the trigeminal nerves across the forehead and the greater occipital nerves at the back of the head. Those peripheral nerves carry signals inward toward brainstem and broader networks involved in mood regulation. TMS has a much deeper evidence base and substantially more long-term clinical experience. Proliv’s advantage is accessibility: you use it at home rather than traveling to a TMS clinic five days a week.
Can I do Proliv and TMS or Spravato at the same time? I wouldn’t recommend routinely combining them right now. People receiving other brain stimulation treatments were excluded from the Proliv pivotal trial, including people currently receiving TMS, tDCS, VNS, or other electrical brain stimulation, and recent TMS was also excluded. There also isn’t good evidence yet for combining Proliv with Spravato. That doesn’t prove the combinations are dangerous. It means we don’t know whether they add benefit, add risk, or simply make it impossible to tell which treatment is doing what. I would usually rather sequence them thoughtfully.
Can Proliv be used for bipolar depression? Not based on the current evidence or FDA indication. People with bipolar depression, or even a psychiatric history suspicious for bipolar depression, were excluded from the pivotal trial. The FDA also lists mania as a potential depression-related adverse effect. So while Proliv has evidence for unipolar major depression, we really do not know its efficacy or switch risk in bipolar depression. I would use treatments with actual bipolar-depression evidence instead.
How long until it works? I would give it time. There was improvement in both active and sham groups by week four, but the difference between them was not statistically significant at that point. The primary controlled outcome was at eight weeks, when active treatment separated from sham. Participants continuing active treatment improved further through week 16, although that second half of the study was open-label and therefore much harder to interpret. Practically, I would not call Proliv a failure after a week or two unless there is a reason we need to stop it.
Do I keep the headset? Not necessarily. Proliv is currently structured around a prescribed 8- or 16-week treatment program, rather than simply buying a headset for indefinite use. At the end, we assess whether it helped and decide whether another treatment cycle makes sense, whether to move on to something else, or whether treatment is complete. Neurolief handles the device return or continuation logistics. Longer-term maintenance options are still evolving.
Can Proliv replace my antidepressant? Not according to its FDA approval. Proliv is approved as an adjunctive treatment, meaning it is added to antidepressant treatment rather than replacing it. In the pivotal trial, participants remained on a stable antidepressant while using the device, and the FDA-approved manual specifically says that Proliv does not substitute for medication. If it works very well and we eventually want to reconsider your medication regimen, that would be a separate clinical decision rather than part of starting Proliv.
Who can prescribe Proliv? Proliv is prescription-only. The FDA labeling restricts it to sale by or on the order of a physician or psychiatrist, who reviews whether the treatment is appropriate and supervises the clinical course. I am able to prescribe Proliv for appropriate patients in California. Neurolief then handles fulfillment, shipping, device onboarding, app setup, and technical support while we continue to monitor the actual depression treatment.
This page is educational and does not replace an individualized medical evaluation. Proliv®Rx is a prescription medical device. Treatment eligibility, risks, alternatives, and monitoring should be reviewed with a qualified clinician.
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