This study is testing if Deep Brain Stimulation (DBS) using the Medtronic SenSight Directional DBS lead can help people with treatment-resistant depression. Researchers want to see if this device is safe and effective in improving depression symptoms and overall well-being. You might be able to join if you are 18-65 years old and have been diagnosed with Major Depression Disorder or Bipolar Disorder (I/II) that hasn't responded to other treatments, with specific depression scale scores (HDRS or MADRS of at least 21). The main way they'll measure success is by looking at changes in your depression symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS) after 12 months. The current status of the study is unclear.

Study design

This is an interventional study with a planned enrollment of 20 participants. The device will be turned on and off at certain times without participants knowing to assess its effectiveness.

What's involved

You would have a Deep Brain Stimulation device implanted and then be monitored over a 5-year period using multiple questionnaires to track your depression symptoms.

Compensation

Not stated in the trial record.

Follow-up

Participants will be monitored over a 5-year period, with the primary endpoint measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.