Major Depressive Disorder
Conditions
Brief summary
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Interventions
DEVICENeurolief system
Non-invasive cephalic neurostimulation device
Sponsors
Neurolief Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The subject is capable of understanding the study and to sign an informed consent. * Subject is between the ages of 18 to 65 years old. * Unipolar major depressive disorder * Score on the Hamilton Depression Rating Scale (HDRS21) \> 22 * Current MDD episode \>3 months * Nonresponse with \>6 week use of one to six antidepressant in current episode
Exclusion criteria
* History of neurosurgical interventions. * Subjects with metal implants or shrapnel in their head, except for dental implants. * Skin lesion or inflammation at the region of the stimulating electrodes. * Pregnancy or Lactation. * Women of reproductive age not using efficient contraceptive method. * History of cerebrovascular event. * Psychotic or bipolar depression * History of schizophrenia, schizoaffective disorder or other non-mood disorder psychosis * Current delirium, dementia, amnestic disorder or other cognitive disorders * Clinically significant current suicidal intent as assessed by the investigator team. * Obsessive-compulsive disorder or post-traumatic stress disorder * Alcohol and non-alcohol psychoactive substance abuse or dependence * Significant cardiac, medical, or progressive neurological or medical illness * An implantable electrical device such as a pacemaker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 6 weeks | 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. |
| Hamilton Depression Rating Scale (HDRS21) | 6 weeks | Change in the total score on the Hamilton Depression Rating Scale (HDRS21) from baseline (visit 1) to week 6 (visit 4). |
Countries
Israel
Outcome results
None listed