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

NCT02805881 | Completed

• 1 other identifier: NRLF-BY531-CTIL
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Neurolief System treatment

EXPERIMENTAL

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

Interventions

Neurolief system DEVICE

Non-invasive cephalic neurostimulation device

Neurolief System treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurolief Ltd.: lead

Study Sites (1)

Beer- Yakov Nees-Ziona Mental Health Center

Ness Ziona, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Hilik Levkovitz, Prof.

  Deputy Director, Beer- Yakov Nees-Ziona Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 20, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

IL (1)