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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01521052
First received: January 25, 2012
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Depression
Device: dTMS treatment (H1 Coil)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Safety of the H1-Coil [ Time Frame: One Month ] [ Designated as safety issue: Yes ]
    maintaining subject's pre treatment, physical and neurological status.

  • Clinical antidepressant response [ Time Frame: One Month ] [ Designated as safety issue: No ]
    a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.


Secondary Outcome Measures:
  • Clinical antidepressant remission [ Time Frame: One Month ] [ Designated as safety issue: No ]
    exit Hamilton Depression Rating Scale <9.

  • Symptomatic improvement at the end point. [ Time Frame: One Month ] [ Designated as safety issue: No ]
    Change in Hamilton Anxiety Rating Scale (HARS), Quick Inventory of Depression Symptomatology - Self Report (QIDS-SR), Clinical Global Impression (CGI).


Estimated Enrollment: 27
Study Start Date: January 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   68 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521052

Contacts
Contact: Dafna Shefet, MD 972-9-7478524 daphnash@clalit.org.il

Locations
Israel
Shalvata Mental Health Center Not yet recruiting
Hod Hasharon, Israel
Contact: Dafna Shefet, MD    972-9-7478524    daphnash@clalit.org.il   
Principal Investigator: Dafna Shefet, MD         
Sponsors and Collaborators
Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01521052     History of Changes
Other Study ID Numbers: SHA-0001-11
Study First Received: January 25, 2012
Last Updated: January 27, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 22, 2014