Status:
COMPLETED
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Lead Sponsor:
Neurolief Ltd.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02805881
Start Date
May 1 2016
End Date
July 1 2021
Last Update
September 5 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beer- Yakov Nees-Ziona Mental Health Center
Ness Ziona, Israel