Clinical trial NCT01521052: Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depression
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 27
Sex: ALL
Minimum age (years): 68
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety of the H1-Coil
timeFrame: One Month
measure: Clinical antidepressant response
timeFrame: One Month
Secondary outcomes:
measure: Clinical antidepressant remission
timeFrame: One Month
measure: Symptomatic improvement at the end point.
timeFrame: One Month
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
Study officials:
References: