Clinical trial NCT05535062: Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature
Official title: A Prospective, Randomized, Single Blind, Crossover Study to Evaluate Treatment Effects Associated With the NeuroStar New Treatment Feature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: TMS
Major Depressive Disorder
NeuroStar TMS
Lead sponsor: Neuronetics
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be switched between different treatment arms and asked to complete questionnaires.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate Comfort of TMS Treatment
timeFrame: 10 days
Secondary outcomes:
measure: Time to Reach Prescribed Treatment Intensity
timeFrame: 5 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: TMS of South Tampa
state: Florida
Study officials:
affiliation: Neuronetics
name: Steve A Erickson, BS
role: STUDY_DIRECTOR
References: