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Keep this study
Lead
Neuronetics
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.
Age
22–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature
