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

Neurolief Ltd.1 site in 1 country28 target enrollmentMay 2016

ConditionsMajor Depressive Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Neurolief Ltd.
Enrollment: 28
Locations: 1
Primary Endpoint: Hamilton Depression Rating Scale (HDRS21)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

July 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Neurolief Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale (HDRS21)

Time Frame: 6 weeks

Change in the total score on the Hamilton Depression Rating Scale (HDRS21) from baseline (visit 1) to week 6 (visit 4).

Incidence of Treatment-Emergent Adverse Events

Time Frame: 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.