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

NCT05535062 | Completed Results FDA Device

• 1 other identifier: 44-03054-000
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

TMS; Major Depressive Disorder; NeuroStar TMS

Outcome Measures

Primary Outcomes (1)

• Evaluate Comfort of TMS Treatment

  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)

  10 days

Secondary Outcomes (1)

• Time to Reach Prescribed Treatment Intensity

  5 days

Study Arms (2)

Dash protocol ramp first

ACTIVE COMPARATOR

Patients will be randomized after consent to receive a standard Dash protocol ramp. After the ramping phase, participants will receive both active conditions in the order: modified protocol, dash, modified protocol, dash. Protocols will be delivered 24 hours apart.

Device: repetitive Transcranial Magnetic Stimulation

Modified Dash protocol ramp first

ACTIVE COMPARATOR

Patients will be randomized after consent to receive a modified Dash protocol ramp. After the ramping phase, participants will receive both active conditions in the order: dash, modified protocol, dash, modified protocol. Protocols will be delivered 24 hours apart.

Device: repetitive Transcranial Magnetic Stimulation

Interventions

repetitive Transcranial Magnetic Stimulation DEVICE

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

Dash protocol ramp first; Modified Dash protocol ramp first

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 22-70 years.
• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Neuronetics: lead

Study Sites (1)

TMS of South Tampa

Tampa, Florida, 33609, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Neha Goyal
• Organization: Neuronetics

neha.goyal@neurostar.com

763-528-1599

Study Officials

• Steve A Erickson, BS

  Neuronetics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study will be randomized to avoid any bias in treatment arm assignment. Subjects will be blinded to the actual treatment arm throughout the study to allow patient to provide an honest assessment of the treatment they are receiving daily. Subjects will not be informed of the treatment at the end of their study participation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be switched between different treatment arms and asked to complete questionnaires.

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 10, 2022
• Study Start: November 7, 2022
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Locations

US (1)