Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature (Comfort Start)

Neuronetics

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Device: repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05535062

44-03054-000

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 22 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Dash protocol ramp first

Active Comparator group

Description:

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.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation

Modified Dash protocol ramp first

Active Comparator group

Description:

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.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation