Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Not Applicable
Completed
- Conditions
- Major Depressive Disorder
- Interventions
- Device: Neurolief system
- Registration Number
- NCT02805881
- Lead Sponsor
- Neurolief Ltd.
- Brief Summary
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neurolief System treatment Neurolief system Treatment with the Neurolief system will be applied by the subject at his home and/or surrounding daily during a period of six weeks
- Primary Outcome Measures
Name Time Method Hamilton Depression Rating Scale (HDRS21) 6 weeks Change in the total score on the Hamilton Depression Rating Scale (HDRS21) from baseline (visit 1) to week 6 (visit 4).
Incidence of Treatment-Emergent Adverse Events 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beer- Yakov Nees-Ziona Mental Health Center
🇮🇱Ness Ziona, Israel