Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
NCT ID: NCT02805881
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2016-05-31
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Neurolief system
Non-invasive cephalic neurostimulation device
Interventions
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Neurolief system
Non-invasive cephalic neurostimulation device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Neurolief Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hilik Levkovitz, Prof.
Role: PRINCIPAL_INVESTIGATOR
Deputy Director, Beer- Yakov Nees-Ziona Mental Health Center
Locations
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Beer- Yakov Nees-Ziona Mental Health Center
Ness Ziona, , Israel
Countries
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Other Identifiers
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NRLF-BY531-CTIL
Identifier Type: -
Identifier Source: org_study_id
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