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Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia

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ClinicalTrials.gov Identifier: NCT00685321
Recruitment Status : Unknown
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was:  Recruiting
First Posted : May 28, 2008
Last Update Posted : January 5, 2012
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center

Brief Summary:

Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia (deficit syndrome), currently treated with atypical antipsychotics.

Patient Population: The intention is to treat 45 patients diagnosed with schizophrenia, who are currently suffering mainly from negative symptoms and cognitive deficits (deficit syndrome). The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age, and have PANSS negative≥21 and PANSS positive<24. Patients will be recruited from both academic and private research centers.

Structure: The study is a randomized, prospective, 8 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.

Concurrent Control: The study group will receive active rTMS treatment and the control group will receive an inactive, sham treatment.


Condition or disease Intervention/treatment Phase
Schizophrenia Device: H1 deep TMS coil Device: Sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
Study Start Date : June 2008
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
deep TMS treatment
Device: H1 deep TMS coil
20 daily deep rTMS treatment
Sham Comparator: 2
inactive treatment
Device: Sham
inactive treatment



Primary Outcome Measures :
  1. SANS [ Time Frame: 1.5 year ]

Secondary Outcome Measures :
  1. SOFAS [ Time Frame: 1.5 Year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria.
  2. Right hand dominant.
  3. Scores in PANSS negative questionnaire above 21.
  4. Gave informed consent for participation in the study.
  5. Negative answers on safety screening questionnaire for transcranial magnetic stimulation
  6. stable on the same antipsychotic medication for at least two months prior to entering the study.
  7. Negative answers to all questions in the TMS safety questionnaire (attached ).

Exclusion Criteria:

  1. Diagnosed as suffering from another axis 1 disorder .
  2. Scores in PANSS positive questionnaire above 24.
  3. History of epilepsy, seizure, or hot spasm.
  4. History of epilepsy within first-degree relatives.
  5. History of head injuries.
  6. History of metal in the head (outside the mouth space).
  7. History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
  8. History of migraines.
  9. History of hearing loss (not due to aging) or cochlear implants.
  10. History of drug or alcohol abuse during the last year.
  11. Women - Pregnancy or not using a reliable method of birth control.
  12. Inability to achieve satisfying level of communication with the subject.
  13. suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire
  14. Custodians.
  15. Participation in another medical study during the experiment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685321


Contacts
Contact: liron rabani, Phd. student 972-97478644 lironrab@clalit.org.il

Locations
Israel
Shalvata Mental Helath Center Recruiting
Hod Hasharon, Israel
Contact: Hilik Levkovitz, prof.    972-9-7478569    ylevk@clalit.org.il   
Shalvata Not yet recruiting
Hod hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: yechiel levkovitz, MD Shalvate mental health center

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT00685321     History of Changes
Other Study ID Numbers: 0024-07-SHA
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Shalvata Mental Health Center:
schizophrenia
TMS
brain stimulation
negative symptoms
clinical improvement
cognitive improvement

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders