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Medtronic SenSight Directional DBS lead · 1 trial · 1 indication
The MADRS is the Montgomery-Asberg Depression Rating Scale, which at 12 months will be the primary endpoint. The investigators hypothesize is that there will be a significant effect of being stimulated (ON) versus not simulated (OFF) on MADRS scores. Also, that at 12 months 50% of the patients will be responders.
| Arm | Type | Description |
|---|---|---|
| Discontinuation Phase Group 1 | EXPERIMENTAL | Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks. |
| Discontinuation Phase Group 2 | EXPERIMENTAL | Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks. |
| Name | Type | Description |
|---|---|---|
| Medtronic SenSight Directional DBS lead | DEVICE | At the ninth month post DBS implantation, the participant will enter a discontinuation phase of a duration of 6 weeks. The device will be turned on and off without participants' knowledge. After 6 weeks, the device will be turned back on if it was off. Whether the stimulation is active or not, it will be double blinded. |
Inclusion Criteria: 1. Major Depression Disorder (MDD) or Bipolar Disorder (I /II) diagnosed by Structured Clinical Interview for DSM-V (SCID I/DSM-V) 2. Age 18 - 65 years. 3. 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items and/or Montgomery-Asburg Depress...
Medtronic SenSight Directional DBS lead is an investigational device being studied for treatment resistant depression. It is a directional deep brain stimulation lead that delivers electrical stimulation to targeted brain regions. The device is currently in Phase 1 clinical development for this psychiatric indication.
Medtronic SenSight Directional DBS lead is developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker MDT. The company is conducting clinical research to evaluate the device for treatment resistant depression.
Medtronic SenSight Directional DBS lead is in Phase 1 clinical development. It is an investigational device, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for treatment resistant depression.
Medtronic SenSight Directional DBS lead is being evaluated in a Phase 1 clinical trial registered as NCT06096207, titled "DBS for Depression." This randomized, double-blind, controlled study is recruiting 20 participants with treatment resistant depression in the United States.
Medtronic SenSight Directional DBS lead is a directional deep brain stimulation lead, which allows electrical current to be directed to specific brain areas. It is being studied specifically for treatment resistant depression, a condition for which DBS is considered investigational. The device is currently in Phase 1 trials.