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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Device: dTMS treatment (H1 Coil)

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Hod Hasharon, Israel
    • Shalvata Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 68 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: elderly depressed patients; 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shalvata Mental Health Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Estimate): January 30, 2012
• Last Update Submitted That Met QC Criteria: January 27, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: SHA-0001-11