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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2023-09-27

Brief Summary

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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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Detailed Description

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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

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Dash protocol ramp first

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.

Group Type ACTIVE_COMPARATOR

repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Modified Dash protocol ramp first

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.

Group Type ACTIVE_COMPARATOR

repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Interventions

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repetitive Transcranial Magnetic Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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.

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

7\. 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.

6\. Known or suspected pregnancy.

Minimum Eligible Age

22 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No