NCT00685321

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Shalvata Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	H1 deep TMS coil	20 daily deep rTMS treatment
DEVICE	Sham	inactive treatment

Timeline

• Start date: 2008-06-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2008-05-28
• Last updated: 2012-01-05

Locations

2 sites across 1 country: Israel