Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
- SANS [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]
- SOFAS [ Time Frame: 1.5 Year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
deep TMS treatment
Device: H1 deep TMS coil
20 daily deep rTMS treatment
Sham Comparator: 2
|Contact: liron rabani, Phd. email@example.com|
|Shalvata||Not yet recruiting|
|Hod hasharon, Israel|
|Shalvata Mental Helath Center||Recruiting|
|Hod Hasharon, Israel|
|Contact: Hilik Levkovitz, prof. 972-9-7478569 firstname.lastname@example.org|
|Principal Investigator:||yechiel levkovitz, MD||Shalvate mental health center|