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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT05535062
• Lead Sponsor: Neuronetics

Brief 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.

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Study Start: 2022-11-07
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-27
• Results First Submitted: 2024-09-26
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Results First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

  3. Subject has MDD diagnosis according to applicable DSM-IV, DSM-IV-TR, DSM-V, ICD-9, or ICD-10 criteria.

  4. 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.

  5. Subject must agree not to take analgesic pain medication(s) within 8 hours prior to TMS therapy sessions.

  6. 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.

  2. Physician intends to treat the subject with an off-label TMS Therapy or indication.

  3. 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.

  4. Known or suspected pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dash Protocol	repetitive Transcranial Magnetic Stimulation	Patients will be randomized after consent to receive standard Dash protocol
Modified Dash protocol with the New feature enabled	repetitive Transcranial Magnetic Stimulation	Patients will be randomized after consent to receive modified Dash protocol with the New feature enabled

Primary Outcome Measures

Name	Time	Method
Evaluate Comfort of TMS Treatment	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 Outcome Measures

Name	Time	Method
Time to Reach Prescribed Treatment Intensity	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).

Trial Locations

Locations (1)

TMS of South Tampa; 🇺🇸 Tampa, Florida, United States