The Clinical Evidence Behind TMS Therapy

15+ years of post-clearance data. Millions of real-world treatments. Consistent outcomes.

NeuroStar TMS received FDA clearance for Major Depressive Disorder in 2008 — the culmination of a pivotal randomized controlled trial demonstrating statistically significant superiority over sham TMS in treatment-resistant patients. Since that clearance, more than 5.5 million treatments have been delivered, producing one of the largest real-world outcomes databases in psychiatry.

Key findings from the NeuroStar post-marketing outcomes registry and published clinical literature are summarized below. High Peaks TMS uses NeuroStar exclusively — ensuring that the outcomes data described here directly corresponds to the equipment and protocols used in our clinic.

• 01
  58% response rate in treatment-resistant depressionThe FDA pivotal trial and subsequent registry data demonstrate approximately 58% of TRD patients achieve clinically meaningful response — defined as ≥50% reduction in depression severity scores.
• 02
  30% full remission rateApproximately 30% of patients who complete a TMS course achieve full remission — complete resolution of depressive symptoms meeting diagnostic thresholds.
• 03
  12+ months average maintained improvementRegistry data shows that TMS responders maintain their clinical improvement for an average of 12 or more months following the completion of their treatment course.
• 04
  Durable retreatment responsePatients who respond to an initial TMS course and subsequently require retreatment demonstrate similar or higher response rates on subsequent courses — evidence that the underlying neuroplastic changes are retrievable.