N/A
Completed N=40
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
| Outcome | Result | p-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.
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.