High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients

Study Overview
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Brief Summary
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A randomized, double-blind sham-controlled trial of high frequency rTMS treatment for cognitive impairments in 120 chronic schizophrenia patients

Detailed Description
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OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex in the treatment of cognitive impairments in 120 chronic patients with schizophrenia. METHODS: Clinical Trial: The study consists of 8 weeks of treatment. Assessment Procedures: 2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the Positive and Negative Syndrome Scale (PANSS). Patients are interviewed at screening, at at baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks. 2.2 Cognitive tests: RBANS was used to assess the cognitive function by three psychologists, which is comprised of a total score and 5 age-adjusted index scores for attention, language, delayed and immediate memory and visuospatial/construction. A translated and adapted Chinese version of RBANS has been evaluated for the test-retest reliability and clinical validity between schizophrenia patients and control subjects. Cognitive performance was measured at baseline and at 8-weeks. 2.3 Side Effects: TESS was used to assess the side effect at baseline and every 2 weeks. 2.5 Weight gain measurement: weight gain every week

Official Title
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A Randomized, Double-blind Sham-controlled Trial of High Frequency rTMS for Cognitive Impairments in Chronic Schizophrenia Patients

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: 10 Hz treatment group
* Device: 20 Hz treatment group
* Device: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizopherenia by two senior psychiatrists Male Right-handed Between 18 and 60 years and Han Chinese Duration of symptoms at least 60 months Received stable doses of antipsychotic drugs at least 12 months With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS < 24) Exclusion Criteria: A DSM-IV Axis I diagnosis other than schizophrenia Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension) Severe headache for unknown reasons and cardiovascular diseases, intra-cranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months Past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures Education level less than 5 years by subject report, Receiving or planning to start the psychotherapy during the rTMS treatment or past received psychotherapy 6 months before the current study Subjects who suffered from alcohol or illegal drug abuse/dependence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 Hz treatment group<br>In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks. | Device: 10 Hz treatment group<br>* 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.<br>|
| Experimental: 20 Hz treatment group<br>In active rTMS, 20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks. | Device: 20 Hz treatment group<br>* 20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.<br>|
| Sham Comparator: Control Group<br>In sham rTMS, all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated. | Device: Control Group<br>* all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatable Battery for the Assessment of Neuropsychological Status for cognition | cognitive performance | 8 weeks | 
| Positive and Negative Syndrome Scale for clinical symptoms | clinical symptoms | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Symptoms Scale for side effects | Side effect | 8 weeks | 

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