Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
NCT ID: NCT00685321
Last Updated: 2012-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2008-06-30
2013-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
deep TMS treatment
H1 deep TMS coil
20 daily deep rTMS treatment
2
inactive treatment
Sham
inactive treatment
Interventions
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H1 deep TMS coil
20 daily deep rTMS treatment
Sham
inactive treatment
Eligibility Criteria
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Inclusion 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
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.
18 Years
65 Years
ALL
No
Sponsors
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Shalvata Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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yechiel levkovitz, MD
Role: PRINCIPAL_INVESTIGATOR
Shalvate mental health center
Locations
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Shalvata Mental Helath Center
Hod HaSharon, , Israel
Shalvata
Hod HaSharon, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0024-07-SHA
Identifier Type: -
Identifier Source: org_study_id
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