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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: H1 deep TMS coil
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>deep TMS treatment | Device: H1 deep TMS coil<br>* 20 daily deep rTMS treatment<br>|
| Sham Comparator: 2<br>inactive treatment | Device: Sham<br>* inactive treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SANS |  | 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFAS |  | 1.5 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, schizophrenia, brain stimulation, negative symptoms, clinical improvement, cognitive improvement