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

Major Depressive Disorder Clinical Trial

— CTO-TNS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805881
• Other study ID #: NRLF-BY531-CTIL
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: July 2021

Study information

• Verified date: August 2021
• Source: Neurolief Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Neurolief system
Non-invasive cephalic neurostimulation device

Locations

Country	Name	City	State
Israel	Beer- Yakov Nees-Ziona Mental Health Center	Ness Ziona

Sponsors (1)

Lead Sponsor	Collaborator
Neurolief Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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