Repetitive Transcranial Magnetic Stimulation for the Treatment of Negative Symptoms in Schizophrenia Patients.

Study Overview
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Brief Summary
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This study is to determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of negative symptoms in schizophrenia patients

Detailed Description
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The principal objective of this trial is to investigate the effect of high frequency rTMS on negative symptoms in schizophrenia.

Official Title
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A Randomized Double-blind Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Negative Symptoms in Schizophrenia Patients.

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of schizophrenia according to DSM-IV； 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: rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure; 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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active rTMS<br>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). | Device: Repetitive Transcranial Magnetic Stimulation<br>* Stimulate the dorsomedial prefrontal cortex for 4 weeks.<br>|
| Sham Comparator: Sham rTMS<br>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. | Device: Repetitive Transcranial Magnetic Stimulation<br>* Stimulate the dorsomedial prefrontal cortex for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in clinical improvement of negative symptoms (Scale for Assessment of Negative Symptoms [SANS], and Positive and Negative Syndrome Scale [PANSS] negative symptoms subscale) |  | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Positive and Negative Syndrome Scale [PANSS] positive symptoms subscale |  | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) | 
| Change from baseline in Calgary Depression Scale for Schizophrenia [CDSS] |  | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) | 
| Change from baseline in clinical global impression [CGI] |  | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) | 
| Change from baseline in WHO Disability Assessment Schedule 2.0 [WHODAS 2.0] |  | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) | 
| Change from baseline in Simpson-Angus Scale [SAS] |  | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) | 
| Change from baseline in Clinician Rated Dimensions of Psychosis Symptom [CRDPS] |  | 3 times (Before treatment,immediately after treatment,4 weeks after treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, rTMS