Major Depressive DisorderCTO-TNSNCT02805881
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
A study testing Neurolief system in people with Major Depressive Disorder, run by Neurolief Ltd. at 1 site in Israel.
Trial summary
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Neurolief system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Being tested
- Neurolief system
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurolief systemDevice
Non-invasive cephalic neurostimulation device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Neurolief system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurolief Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hilik Levkovitz, Prof., Principal investigator, Deputy Director, Beer- Yakov Nees-Ziona Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805881
- Sponsor's protocol ID
- NRLF-BY531-CTIL
- Acronym
- CTO-TNS
- Status last verified
- Aug 2021
- First submitted
- 7 Jun 2016
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT02805881
- Acronym / sponsor ID
- CTO-TNS / NRLF-BY531-CTIL
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Neurolief Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurolief System treatment | Experimental | Device: Neurolief systemTreatment with the Neurolief system will be applied by the subject at his home and/or surrounding daily during a period of six weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurolief systemNon-invasive cephalic neurostimulation device | Device | Neurolief System treatment |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 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.
Hamilton Depression Rating Scale (HDRS21)
Time frame: 6 weeks
Change in the total score on the Hamilton Depression Rating Scale (HDRS21) from baseline (visit 1) to week 6 (visit 4).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilik Levkovitz, Prof. principal investigator
Deputy Director, Beer- Yakov Nees-Ziona Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurolief system in people with Major Depressive Disorder, run by Neurolief Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.