Back to resultsSafety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD) (CTO-TNS)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Neurolief system
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
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.
- 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.
Sites / Locations
- Beer- Yakov Nees-Ziona Mental Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neurolief System treatment
Arm Description
Treatment with the Neurolief system will be applied by the subject at his home and/or surrounding daily during a period of six weeks
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02805881
Brief Title
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Acronym
CTO-TNS
Official Title
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
July 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurolief Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurolief System treatment
Arm Type
Experimental
Arm Description
Treatment with the Neurolief system will be applied by the subject at his home and/or surrounding daily during a period of six weeks
Intervention Type
Device
Intervention Name(s)
Neurolief system
Intervention Description
Non-invasive cephalic neurostimulation device
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
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.
Time Frame
6 weeks
Title
Hamilton Depression Rating Scale (HDRS21)
Description
Change in the total score on the Hamilton Depression Rating Scale (HDRS21) from baseline (visit 1) to week 6 (visit 4).
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilik Levkovitz, Prof.
Organizational Affiliation
Deputy Director, Beer- Yakov Nees-Ziona Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beer- Yakov Nees-Ziona Mental Health Center
City
Ness Ziona
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
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