Status:
UNKNOWN
Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
Lead Sponsor:
Shalvata Mental Health Center
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
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), curr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00685321
Start Date
June 1 2008
End Date
January 1 2013
Last Update
January 5 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Shalvata Mental Helath Center
Hod HaSharon, Israel
2
Shalvata
Hod HaSharon, Israel