Ignite Creation Date:
2024-05-05 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00685321
Status:
UNKNOWN
Last Update Posted:
2012-01-05
First Post:
2008-05-25
Brief Title:
Tolerability Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation in Subjects With Negative Symptoms and Cognitive Deficits of Schizophrenia
Sponsor:
Shalvata Mental Health Center
Organization:
Shalvata Mental Health Center
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2012-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ObjectivesThe 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 negative21 and PANSS positive24 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
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 negative21 and PANSS positive24 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None