NCT02127879

Intensive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia

High-frequency Repetitive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia: The Double-blind Sham-controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Brno University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine whether intensive repetitive transcranial magnetic stimulation (I-rTMS) is effective in the treatment of negative symptoms in schizophrenia patients and whether it has a positive influence on their cognitive functions, social functions, quality of life, alpha frequency and cortical silent period changes. Also, this study should provide data about safety and tolerability this I-rTMS treatment in schizophrenia patients.

Detailed description

Patients undergo 5x EEG from safety and research reasons during the study. Stimulation coil location (left DLPFC) is determined by magnetic resonance imaging (1,5T, 3D- TFE, voxel size 1 x 1 x 1 mm, Intera MR scanner) and stereotactic neuronavigation (Brainsight Frameless). Patients are evaluated by several psychiatric scales. Positive and negative symptom scale (PANSS) is applied before the first stimulation, at the end of every stimulation day and two weeks after the last stimulation (a total 6). Other psychiatric evaluations used are Clinical global impression (CGI), Sheehan disability scale (SDS), Personal and social performance scale (PSP) and Montgomery-Asberg Depression Scale (MADRS), Calgary depression scale for schizophrenia (CDSS); (MADRS and CDSS are for the exclusion of depression). These scales were used only before the start of the first stimulation, after its completion and two weeks after the last test.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation	16 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. pause is between every stimulation session for safety reasons.v
DEVICE	Transcranial Magnetic Stimulation with sham coil	16 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. Pause is between every stimulation session for safety reasons.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-05-01
• Last updated: 2014-05-05

Locations

1 site across 1 country: Czechia