NCT05535062

Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature

A Prospective, Randomized, Single Blind, Crossover Study to Evaluate Treatment Effects Associated With the NeuroStar New Treatment Feature

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Neuronetics · Academic / Other
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the comfort of the NeuroStar® Advanced Therapy System regular prescribed TMS protocol versus a New Feature.

Detailed description

This is a 2 week study to evaluate the New Feature an exclusive feature available on the NeuroStar® Advanced Therapy System. This feature introduces a series of stepped pulses within each pulse train ramping up the pulse magnitude to the prescribed treatment level. Patients will be randomized after consent to receive either the standard Dash protocol or the modified Dash protocol with the New feature enabled. The subjects will be switched between treatment protocols and asked to complete comfort, and depression questionnaires.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	repetitive Transcranial Magnetic Stimulation	the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2022-09-10
• Last updated: 2025-02-17
• Results posted: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study