Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805881
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Neurolief Ltd.

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Neurolief system Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Study Start Date : May 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805881


Contacts
Layout table for location contacts
Contact: Danielle Antler +972 (8) 9258474 danielle.antler@BeerNess.HEALTH.GOV.IL

Locations
Layout table for location information
Israel
Beer- Yakov Nees-Ziona Mental Health Center Recruiting
Ness Ziona, Israel
Contact: Danielle Antler    +972 (8) 9258474    danielle.antler@BeerNess.HEALTH.GOV.IL   
Sponsors and Collaborators
Neurolief Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Hilik Levkovitz, Prof. Deputy Director, Beer- Yakov Nees-Ziona Mental Health Center
Layout table for additonal information
Responsible Party: Neurolief Ltd.
ClinicalTrials.gov Identifier: NCT02805881    
Other Study ID Numbers: NRLF-BY531-CTIL
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms