Tolerability, Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00685321|
Recruitment Status : Unknown
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was: Recruiting
First Posted : May 28, 2008
Last Update Posted : January 5, 2012
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 or disease||Intervention/treatment||Phase|
|Schizophrenia||Device: H1 deep TMS coil Device: Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||January 2013|
deep TMS treatment
Device: H1 deep TMS coil
20 daily deep rTMS treatment
Sham Comparator: 2
- SANS [ Time Frame: 1.5 year ]
- SOFAS [ Time Frame: 1.5 Year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685321
|Contact: liron rabani, Phd. email@example.com|
|Shalvata Mental Helath Center||Recruiting|
|Hod Hasharon, Israel|
|Contact: Hilik Levkovitz, prof. 972-9-7478569 firstname.lastname@example.org|
|Shalvata||Not yet recruiting|
|Hod hasharon, Israel|
|Principal Investigator:||yechiel levkovitz, MD||Shalvate mental health center|