Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Non-invasive cephalic neurostimulation device
Beer- Yakov Nees-Ziona Mental Health Center
Ness Ziona, Israel
Incidence of Treatment-Emergent Adverse Events
Safety measures will be recorded and evaluated at every evaluation visit. It will be coded using the Medical Dictionary for Regulatory Activities. Vital signs (blood pressure and pulse) will be assessed and documented at each evaluation visit.
Time frame: 6 weeks
Hamilton Depression Rating Scale (HDRS21)
Change in the total score on the Hamilton Depression Rating Scale (HDRS21) from baseline (visit 1) to week 6 (visit 4).
Time frame: 6 weeks
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