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N/A Completed N=40 Randomized Single-blind Treatment

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

Source: ClinicalTrials.gov NCT05535062 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Evaluate Comfort of TMS Treatment — 29.9; 29.3 VAS score on a scale

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Evaluate Comfort of TMS Treatment
29.9; 29.3
SECONDARY
Time to Reach Prescribed Treatment Intensity
1.78; 1.9

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.
  • 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.

Exclusion Criteria

  • 1. 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05535062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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