NeuroStar is the leading TMS therapy for depression with four FDA-cleared indications, treating over 223,000 patients across 8.2 million sessions without drugs or surgery.
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NeuroStar
Over eight million treatment sessions. More
than 1,100 practices across the United States. Four separate FDA clearances
spanning adult depression, anxious depression, obsessive-compulsive disorder,
and adolescent depression. Those numbers belong to a single device that does
not use drugs, does not require surgery, and does not involve sedation.
Neuronetics, a medical technology company headquartered in Malvern,
Pennsylvania, and listed on NASDAQ under the ticker STIM, built NeuroStar Advanced
Therapy as a TMS therapy for depression that treats mental health conditions at
their neurological source rather than through the body's chemical or digestive
systems.
The concept behind the technology is direct.
Specific areas of the brain regulate mood. In people with depression, the
synapses in those areas become underactive, weakening the connections that
support healthy emotional function. Rather than introducing a medication that
travels through the bloodstream, NeuroStar delivers focused magnetic pulses
directly to the affected brain region to reactivate those dormant connections.
CEO Keith J. Sullivan leads the company, which holds the largest clinical
dataset of any TMS system for depression, including 15 studies, 31 publications,
and two randomized controlled trials.
NeuroStar uses a proprietary figure-eight coil
that focuses magnetic energy with precision on the brain's mood-regulating
area. The pulses are similar in strength to those generated by an MRI machine.
Each pulse stimulates neurons in the targeted region, reactivating synapses and
restoring the brain's ability to regulate neurotransmitter levels. Because the
treatment targets one specific brain area rather than circulating through the
entire body, it avoids the systemic side effects commonly associated with
antidepressant medications. According to NeuroStar, the therapy has no effects
on cognition or sleep.
What distinguishes NeuroStar from other TMS
devices is a patented technology called Contact Sensing. This system provides
continuous real-time feedback in three dimensions during every session. If
contact between the coil and the patient's head is compromised at any point,
the system immediately alerts the clinician. This ensures the patient receives
the exact prescribed dose with every pulse, every session, eliminating
variability in treatment delivery. Additionally, NeuroStar offers TouchStar
Theta Burst, a newer protocol that uses higher-frequency pulses to reduce
session times from the standard 19 to 40 minutes down to approximately three
minutes. Providers can add this protocol through a simple software update
without purchasing new hardware.
NeuroStar's versatility lies in the fact that a
single device treats four distinct conditions without requiring hardware
upgrades or additional equipment purchases between indications.
The first clearance addressed adult major
depressive disorder in patients who had not found sufficient relief from
antidepressant medication. Clinical data from this indication showed that 83%
of patients completing treatment experienced measurable depression relief, and
62% achieved full remission. Proven effectiveness extended through 12 months in
treatment-resistant patients, with a clinical discontinuation rate of only 5%.
The second and third clearances, both granted
in the same period, expanded the device to anxious depression and
obsessive-compulsive disorder. Anxious depression covers patients diagnosed
with major depressive disorder who also experience significant comorbid anxiety
symptoms. For these patients, NeuroStar decreases anxiety symptoms alongside
treating the underlying depression. For OCD, NeuroStar functions as an adjunct
therapy used in combination with medication or behavioral treatment.
The fourth and most recent clearance authorized
NeuroStar as a first-line add-on TMS therapy for depression in adolescents aged
15 to 21, making it the first and only TMS device cleared for this age group.
Nearly 10,000 adolescents have been treated across over 300,000 sessions. Data
presented at a major child psychiatry conference showed nearly 60% of treated
adolescents reached remission. Prior clinical studies reported a 78% response
rate and 48% remission rate in this population. The FDA reviewed data from the
TrakStar registry alongside published literature and concluded that NeuroStar
was substantially equivalent in safety and effectiveness as an adjunct to
antidepressant therapy.
A NeuroStar session takes place in a
physician's office, clinic, or hospital. The patient reclines in a comfortable
chair while a cushioned coil is positioned precisely against their head. There
is no anesthesia and no sedation. The patient remains fully awake and alert
throughout. During treatment, they feel a tapping, tingling, or warming
sensation where the coil is positioned. This sensation is usually temporary and
subsides with subsequent sessions.
A typical treatment course consists of 36
sessions delivered over approximately six weeks, with daily sessions five days
per week. With the standard protocol, each session lasts between 19 and 40
minutes. With TouchStar Theta Burst, sessions take approximately three minutes.
After each session, the patient can drive home and resume all normal activities
immediately. There is no recovery period. The most common side effect is mild
to moderate pain or discomfort at or near the treatment site, which typically
subsides within the first week of treatment. There is a rare risk of seizure
estimated at less than 0.1% per patient. The treatment is not appropriate for
individuals with implanted metallic devices in or near the head, and patients
with a history of seizures should discuss eligibility with their physician.
Most major insurance companies cover NeuroStar for major depressive disorder
and anxious depression, with new payors frequently adding OCD coverage.
Mental health treatment has historically relied
on two primary tools: psychotherapy and medication. For millions of patients,
these options provide meaningful relief. For a significant number, they do not.
Antidepressants work through the body's chemical systems, which means they
affect not only the brain but also digestion, sleep, weight, and sexual
function. For adolescents in particular, the range of approved medications has
been extremely limited compared to what is available for adults.
TMS therapy for depression offers a third
pathway that works alongside existing treatments rather than replacing them. It
targets the brain directly without entering the bloodstream, which is why it
avoids the systemic side effects that cause many patients to discontinue
medication. NeuroStar is the number one physician-recommended TMS therapy in
the United States, backed by the world's largest depression outcomes registry.
The same device now treats four conditions across patients ranging from
adolescents to older adults, all without requiring different hardware. Whether
TMS continues to expand into additional mental health indications will depend
on ongoing clinical research. For the conditions it already covers, the
clinical data across 223,000 patients and 8.2 million sessions represent one
of the most extensively documented non-drug treatment records in mental
healthcare.
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