An interventional study of repetitive TMS and Sham rTMS in Schizophrenia, sponsored by Suzhou Psychiatric Hospital. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-09-06.
Sponsored by Suzhou Psychiatric Hospital · Not applicable, Interventional, and Treatment
In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.
3,565 studies on the registry are indexed under Schizophrenia; 492 are open to participants now.
This study's enrollment of 47 is below the median of 71 across 2,945 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Suzhou Psychiatric Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).
Device: repetitive TMS
all procedures were identical except they were the unmagnetized steel cylinders, instead of cylindrical magnets, that were rotated. Participants were, therefore, unable to distinguish between active and sham rTMS.
Device: Sham rTMS
Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).
Also known as: rTMS
Sham rTMS, without stimulation
Scale for the Assessment of Negative Symptoms (SANS)
clinical negative symptoms
Time frame: 4 weeks
Positive and Negative symptom scale (PANSS)
Clinical symptoms
Time frame: 4 weeks
CANTAB
cognition
Time frame: 4 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2012 to primary completion in Feb 2014, 19 months.
Of 755 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 19 months is below that.
Counting every sponsor, half of 768 studies reached it within 33 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Suzhou Psychiatric Hospital