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

Neurolief

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Device: Neurolief system

Study type

Interventional

Funder types

Industry

Identifiers

NRLF-BY531-CTIL

Details and patient eligibility

About

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

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.