depression melancholy depression
Conditions
Interventions
Treatment with MST, applied at 100 Hz at 100% of the maximum device power for
8-10 seconds. Treatment will be continued until a clinical plateau is reached.
We will use MRI and EEG measurements to i
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Eligible participants are men and women aged 18 and above who will be referred for treatment with ECT, have a major depressive episode in the context of MDD based on the Structured Clinical Interview for DSM-IV-TR.
Exclusion criteria
Exclusion criteria: Exclusion criteria will be a history of neurological disorders, head trauma, contraindications to MST, current unstable or serious medical illnesses, pregnancy or breastfeeding, history of ECT in the prior 6 months or failure to previously respond to ECT, or MOCA score lower than 22. More concrete contraindications with respect to the device are: Patients having conductive or any magnetic-sensitive materials implanted in the head or within 30cm of the treatment coil (examples: sutures, clips, coils, magnetic dental implants or implanted insulin pumps). Patients who have an implanted device that is activated or controlled in any way by physiological signals (examples: pacemakers, implantable cardioverter-defibrillators [ICD*s], vagus nerve stimulators [VNS] and wearable cardioverter-defibrillators [WCD*s], even when removed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary objective is to test the feasibility of MST. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondarily, we will descriptively describe the change of the depressive symptom scores of HRSD-17, cognitive scores and tolerability profile of MST patients. Additional endpoints concern changes in functional and structural brain connectivity (as measured with MRI and EEG) networks as a function of MST treatment to derive potential biomarkers for a future clinical trial. | — |
Countries
Netherlands
Contacts
Public ContactI Tendolkar
Radboud Universitair Medisch Centrum
Outcome results
None listed