A Phase 3 interventional study of Active rTMS x sham (placebo) rTMS and sham rTMS in Schizophrenia and Auditory Hallucinations, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-08-12.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 3, Interventional, and Treatment
The primary outcome of this study is to evaluate the effects of low frequency subthreshold repetitive Transcranial Magnetic Stimulation applied to the left temporoparietal cortex of patients with refractory schizophrenia on the severity of auditory hallucinations.
The secondary outcome is to evaluate the effects of the same rTMS protocol on quality of life, functionality and general psychopathology.
Seventeen patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. First group received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
Second group received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and refering auditory hallucinations occuring at least 5 times a day.
132 studies on the registry are indexed under Hallucinations; 36 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 112 interventional studies indexed under Hallucinations.
Browse Hallucinations studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
1Hz rTMS sessions applied to the left temporoparietal cortex of the subjects
Procedure: Active rTMS x sham (placebo) rTMS · Procedure: (1Hz) rTMS applied over the left temporoparietal cortex
Same number of pulses but applied with and angled coil (90 degrees) and placed over the fronto´temporal region
Procedure: Active rTMS x sham (placebo) rTMS · Procedure: sham rTMS
Seventeen right-handed patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. One arm received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC). The other arm received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and referred auditory hallucinations.
Also known as: EMTr
same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region
Also known as: Sham
20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).
Evaluate the effects of low frequency repetitive Transcranial Magnetic Stimulation applied over the left temporoparietal cortex of refractory schizophrenic patients on the severity of auditory hallucinations.
Time frame: 2 years
The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.
Time frame: 2 years
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre