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OpenTrials
Completed

NCT Number: NCT05535062

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

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

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Key information

Age range

22 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TMS of South Tampa

Tampa, Florida, 33609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 22-70 years.
  • 2. Subject qualifies to receive TMS Therapy with the NeuroStar Advanced Therapy System to treat Major Depressive Disorder (MDD) per current FDA-cleared treatment guidelines as evaluated by the treating physician.
  • Subject has MDD diagnosis according to applicable DSM-IV, DSM-IV-TR, DSM-V, ICD-9, or ICD-10 criteria.
  • Subject failed to respond to at least one prior anti-depressant medication. 5. Subject consented to receive TMS Therapy to treat MDD with his or her physician independent of potential participation in this clinical study.
  • Subject must agree not to take analgesic pain medication(s) within 8 hours prior to TMS therapy sessions.
  • Subject provides written consent to take part in the study.

Exclusion criteria

  • 1. Subject satisfies any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
  • Physician intends to treat the subject with an off-label TMS Therapy or indication.
  • Family history of seizures or epilepsy. 4. Subject has received prior TMS. 5. Subject is currently taking analgesic medication or substances which may affect their perception or sensation of pain.
  • Known or suspected pregnancy.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function

Primary outcomes

  1. Evaluate Comfort of TMS Treatment

    Time frame: 10 days

    The average Visual Analog Scale scores for the two conditions Dash protocol and modified DASH.

    VAS - Visual Analog Scale range is 0-100 (0- no pain/discomfort; 100- extreme discomfort/worse pain)

Secondary outcomes

  1. Time to Reach Prescribed Treatment Intensity

    Time frame: 5 days

    Th average time to reach the prescribed treatment intensity. Once TMS therapy begins, adjustments to the stimulation intensity can begin immediately, as needed, according to subject tolerance. The TMS treater will assess if the subject can tolerate escalating the treatment MT by 10% at different time points. At each interval and the end of treatment, the treater will record the current intensity (%MT) achieved. The goal will be to reach and sustain the target intensity established by the treating physician (120%MT).

Sponsors and collaborators

Lead sponsor

Neuronetics

Other

Registry information

Official study title

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

Acronym: Comfort Start

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2022
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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