A Treatment Backed by
Decades of Clinical Evidence
NeuroStar TMS received FDA clearance for the treatment of Major Depressive Disorder in adults and has since accumulated one of the strongest safety records of any psychiatric treatment available. For patients in Fort Lauderdale, Miami, and throughout South Florida asking whether TMS is safe — the answer is grounded in substantial clinical data.
The magnetic pulses used in NeuroStar TMS are comparable in strength to those produced during a standard MRI scan — a technology used routinely and safely in millions of patients each year. TMS delivers these pulses in a focused, controlled manner to a specific region of the brain without affecting surrounding tissue or any other part of the body.
Unlike antidepressant medications, NeuroStar TMS introduces nothing into the body. There are no systemic effects, no chemical interactions, and no risk of drug dependency. The treatment happens entirely through an external magnetic coil that never breaks the skin.
What NeuroStar TMS
Actually Causes vs. Does Not Cause
South Florida patients considering NeuroStar TMS deserve a complete and honest picture. Here is what the clinical data and real patient experience show.
What TMS Can Cause
Scalp Discomfort at the Treatment Site
The most common side effect. Mild to moderate discomfort or tapping sensation at the point where the coil contacts the scalp. This is localized — it does not affect any other part of the body. For most patients it decreases significantly after the first week.
Mild Headache
Some patients experience a mild headache following their first few sessions. This typically resolves on its own and does not persist beyond the initial adjustment period for most patients.
Scalp Tingling or Muscle Twitching
During treatment, the magnetic pulses can cause a mild tingling sensation or slight facial muscle movement near the treatment site. This is temporary and stops as soon as the session ends.
Rare: Seizure Risk (<0.1%)
There is a rare risk of seizure associated with TMS therapy, occurring in fewer than 0.1% of patients. A thorough medical evaluation before treatment screens for any factors that may elevate this risk.
What TMS Does Not Cause
No Weight Changes
TMS does not affect metabolism or appetite.
No Memory Impairment
Zero negative impact on memory or cognitive function.
No Sexual Side Effects
A common concern with antidepressants — not a factor with TMS.
No Sedation or Grogginess
Patients drive themselves home immediately after every session.
No Nausea
Not a side effect of NeuroStar TMS treatment.
No Sleep Disruption
Sleep patterns are unaffected — many patients report improvement.
No Drug Dependency
Nothing enters the body — zero risk of dependency or withdrawal.
The Regulatory Standard
NeuroStar TMS Has Met
NeuroStar TMS received its first FDA clearance for the treatment of Major Depressive Disorder in adults in 2008 — making it one of the longest-standing FDA-cleared TMS systems available today. Since then, its clearance has expanded to include decreasing anxiety symptoms in adults with MDD and as an adjunct treatment for adolescents ages 15 to 21.
FDA clearance for a medical device means the agency has determined the treatment is safe and effective for its indicated use based on clinical evidence. NeuroStar is also the most studied TMS system in the country, backed by large-scale controlled trials and real-world outcomes data from over 4.8 million treatments.
For patients in Fort Lauderdale, Miami, and across South Florida who are weighing the safety of TMS against continued antidepressant use, this regulatory and clinical track record provides a strong foundation for confidence.
Who Should Not
Have TMS Therapy
A thorough medical evaluation before treatment is required. Here are the primary contraindications that our Boca Raton physicians screen for before any patient begins treatment.
Metal Implants Near the Head
NeuroStar TMS should not be used in patients with non-removable conductive metal implants in or near the head. This includes certain cochlear implants, deep brain stimulators, metal plates or screws in the skull, and similar devices. Standard dental work, fillings, and braces are generally not a concern — your physician will review your specific history.
History of Seizure Disorder
Patients with a personal or family history of epilepsy or seizure disorders require careful evaluation before starting TMS. Your physician will review your full neurological history and determine whether the rare seizure risk associated with TMS is appropriate for your situation.
Certain Medical Conditions
Other medical conditions — including active substance use disorders, certain cardiac conditions, or recent significant head injuries — may require additional evaluation. Your physician will conduct a comprehensive review during your candidacy assessment to ensure TMS is appropriate and safe for you specifically.
Every Patient is Individually Evaluated
Before any South Florida patient begins treatment at New Sunrise Mental Health, a physician conducts a full medical and psychiatric evaluation. NeuroStar TMS is only available by prescription — meaning a licensed provider must determine it is appropriate for you before treatment begins.
Over 4.8 Million Treatments.
A Track Record You Can See.
NeuroStar TMS has been administered more than 4.8 million times across clinical practices in the United States. The safety and outcomes data from this scale of real-world use is what gives Fort Lauderdale and Miami patients the confidence to move forward.
*Individual results vary. Based on published clinical outcomes data. Patients' results may vary.
What South Florida Patients
Ask About TMS Safety
Is NeuroStar TMS safer than antidepressants?
TMS and antidepressants have very different safety profiles. Antidepressants carry systemic risks — weight changes, sleep disruption, sexual dysfunction, nausea, and in some cases cardiovascular effects. NeuroStar TMS is localized to the scalp and brain region being treated. It introduces nothing into the body and carries no systemic side effects. The comparison depends on individual health history, which is why a physician evaluation is required before starting either treatment.
Can TMS cause brain damage?
No. There is no clinical evidence that NeuroStar TMS causes brain damage. The magnetic pulses used are similar in strength to standard MRI machines and are delivered in controlled, brief bursts to a specific region of the brain. Over 4.8 million treatments have been performed with an established safety record that does not include brain damage as a reported outcome.
Is TMS safe for older adults?
NeuroStar TMS has been studied and used in adult patients across a wide age range. Older adults who qualify — meaning they have not achieved satisfactory improvement from prior antidepressant medication — can be candidates for TMS. A physician evaluation will assess individual health factors specific to older patients before treatment begins.
Is TMS safe during pregnancy?
The safety of TMS during pregnancy has not been fully established in clinical trials. If you are pregnant or planning to become pregnant, this must be disclosed during your physician evaluation. Your provider will weigh the potential risks and benefits for your specific situation.
How do I know if TMS is safe for me specifically?
The only way to determine whether NeuroStar TMS is safe and appropriate for you is through a physician evaluation. Our Boca Raton team reviews your full medical history, current medications, and any contraindications before treatment is prescribed. Call us at 561-944-0077 to schedule your consultation.
Safe, Effective — and Covered by Most Insurance Plans
NeuroStar TMS is not only FDA-cleared and clinically proven — it is also covered by most major commercial insurance plans, Medicare, and Tricare. For South Florida patients who have been hesitant because of cost concerns, let us find out what your specific plan covers before you make any decisions. This service is completely free.
Ready to Find Out If
TMS Is Right for You?
Our team at New Sunrise Mental Health in Boca Raton is the closest NeuroStar TMS provider to Fort Lauderdale and Miami. We make the evaluation process straightforward and answer every question before you commit to anything.
Physician-led safety evaluation
Every patient is individually assessed before treatment begins.
Free insurance verification
We confirm your coverage before your first appointment.
No pressure, no obligation
The consultation is about finding out if TMS is right for you.
Monday through Thursday availability
10AM to 6PM. We work around your schedule.
Request a Safety Consultation
Tell us a little about your situation and we will reach out within one business day to answer your safety questions and verify your insurance.
🔒 Secure & confidential. We never share your information.
NeuroStar TMS Is Safe.
Find Out If It Is Right for You.
FDA-cleared, backed by 4.8 million treatments, and accessible to Fort Lauderdale and Miami patients from our Boca Raton clinic. The next step is a conversation — and it starts with one call.
561-944-0077950 Peninsula Corporate Circle, Suite 1011 · Boca Raton, FL 33487 · Mon–Thu 10AM–6PM