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

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

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Neurolief system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurolief System treatment<br>Treatment with the Neurolief system will be applied by the subject at his home and/or surrounding daily during a period of six weeks | Device: Neurolief system<br>* Non-invasive cephalic neurostimulation device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 6 weeks |