Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.
NCT ID: NCT02842034
Last Updated: 2018-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-07-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active rTMS
Active treatment will be delivered at an intensity that is 120% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 50 stimuli each (i.e., 3000 stimuli) and an intertrain interval of 10 sec. Treatment will be applied in sequential order to the dorsomedial prefrontal cortices (DMPFC).
Repetitive Transcranial Magnetic Stimulation
Stimulate the dorsomedial prefrontal cortex for 4 weeks.
Sham rTMS
Sham stimulation will be delivered using the same stimulation parameters and at the same site of active treatment, but the coil will be reversed. This method produces sound and some somatic sensation (e.g., contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
Repetitive Transcranial Magnetic Stimulation
Stimulate the dorsomedial prefrontal cortex for 4 weeks.
Interventions
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Repetitive Transcranial Magnetic Stimulation
Stimulate the dorsomedial prefrontal cortex for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 18～55 years old；
* schizophrenic illness duration longer than one year;
* The sum of negative scores in the range Positive and negative symptom score (PANSS) must be 20 points or higher, at least one item from the area of negative symptoms (N1-N7) must be ≥ 4 points (at least moderate, clinically significant symptoms), and improvement in negative symptom-sum (measuring by PANSS) must be 10% or lower during the last two weeks before rTMS stimulation.
* Have a stable and consistent drug treatment at least two weeks prior the rTMS treatment;
* Able to adhere to the treatment schedule;
* IQ≥80;
* Dextromanual, normal vision and hearing;
* Signed an informed consent
Exclusion Criteria
* Acute risk of suicide and impulse；
* patients to be diagnosed according to DSM-IV for substance abused, development delayed;
* suffering from serious physical disease and can not accept the treatment;
* history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG;
* difficult to maintain the current drug treatment for at least 1 month;
* undergoing ECT or MECT in last 3 months;
* current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines.
15 Years
55 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
Responsible Party
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Locations
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Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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rTMS-negative symptoms
Identifier Type: -
Identifier Source: org_study_id
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