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

Phase 2

• Conditions: Depression

• Registration Number: NCT01521052
• Lead Sponsor: Shalvata Mental Health Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-27
• Last Update Submitted: 2012-01-27
• Study First Posted: 2012-01-30
• Last Update Posted: 2012-01-30
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shalvata Mental Health Center; 🇮🇱 Hod Hasharon, Israel