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

August 30, 2021 updated by: Neurolief Ltd.
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ness Ziona, Israel
        • Beer- Yakov Nees-Ziona Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurolief System treatment
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
Non-invasive cephalic neurostimulation device

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurolief Ltd.

Investigators

  • Principal Investigator: Hilik Levkovitz, Prof., Deputy Director, Beer- Yakov Nees-Ziona Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRLF-BY531-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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