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

This study is not yet open for participant recruitment.

Verified by Shalvata Mental Health Center, May 2008

First Received: May 25, 2008 Last Updated: February 4, 2009 History of Changes

Sponsored by:	Shalvata Mental Health Center
Information provided by:	Shalvata Mental Health Center
ClinicalTrials.gov Identifier:	NCT00685321

Purpose

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	Intervention
Schizophrenia	Device: H1 deep TMS coil Device: Sham

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:

SANS [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

SOFAS [ Time Frame: 1.5 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental deep TMS treatment	Device: H1 deep TMS coil 20 daily deep rTMS treatment
2: Sham Comparator inactive treatment	Device: Sham inactive treatment

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Right hand dominant.
Scores in PANSS negative questionnaire above 21.
Gave informed consent for participation in the study.
Negative answers on safety screening questionnaire for transcranial magnetic stimulation
stable on the same antipsychotic medication for at least two months prior to entering the study.
Negative answers to all questions in the TMS safety questionnaire (attached ).

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685321

Contacts

Contact: liron rabani, Phd. student

972-97478644

lironrab@clalit.org.il

Locations

Israel
Shalvata
Hod hasharon, Israel

Sponsors and Collaborators

Shalvata Mental Health Center

Investigators

Principal Investigator:

yechiel levkovitz, MD

Shalvate mental health center

More Information

No publications provided

Responsible Party:	Shalvata mental health center ( Dr. Levkovitz Yechiel )
Study ID Numbers:	0024-07-SHA
Study First Received:	May 25, 2008
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00685321 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:

schizophrenia
TMS
brain stimulation

negative symptoms
clinical improvement
cognitive improvement

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009