Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)

Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)

Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)

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.