Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly

Study Overview
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Brief Summary
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Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in elderly patients suffering from major depressive episode. Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above, currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be conducted before starting the trial (screening), once a week for the trial duration and one month following end of treatment.

Conditions
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Depression

Intervention / Treatment
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* Device: dTMS treatment (H1 Coil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed by a senior psychiatrist as suffering from major depression episode according to DSM-IV (either as a part of a unipolar or a bipolar disorder). Rating on HDRS ≥ 20. Age: 68 years and above Treated for the current depressive episode, at least 6 weeks per antidepressant with one antidepressant in accepted dose, without improvement, and/or intolerance to 2 antidepressants, according to medical chart and ATHF (antidepressant treatment history form) instruction guidelines. Gave informed consent for participation in the study. Negative answers on safety screening questionnaire for TMS. If referred by a treating psychiatrist, he or she approves of the subject's participation in the study. Exclusion Criteria: Axis 2 diagnosis, which is considered prominent to the current depressive episode. Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist. Attempted suicide in the past year. Cognitive impermanent - if MMSE < 24, patient will be further assessed , and may be excluded according to the primary investigator's discretion History of seizure. History of epilepsy or seizure in first degree relatives. Any CNS disorder that may increase risk of seizure significantly History of a significant head injury. History of any metal in the head (outside the mouth). Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps. History of frequent or severe headaches. Use of hearing aids for hearing loss. Known history of cochlear implants. History of drug abuse or alcoholism. Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period. Inadequate communication with the patient. Under custodial care. Participation in current clinical study or clinical study within 30 days prior to this study. Patients suffering from bipolar disorder, not currently treated by mood stabilizers Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.

Ages Eligible for Study
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Minimum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: elderly depressed patients<br>Twenty seven (27) patients aged 68 years or above, currently suffering from a major depressive episode, who did not respond to treatment with at least one antidepressant medications in the recommended dosage and duration, or could not tolerate at least two antidepressants. | Device: dTMS treatment (H1 Coil)<br>* All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the H1-Coil | maintaining subject's pre treatment, physical and neurological status. | One Month | 
| Clinical antidepressant response | a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%. | One Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical antidepressant remission | exit Hamilton Depression Rating Scale <9. | One Month | 
| Symptomatic improvement at the end point. | Change in Hamilton Anxiety Rating Scale (HARS), Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR), Clinical Global Impression (CGI). | One Month |