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A Randomized, Double-blind Sham-controlled Trial of High Frequency rTMS for Cognitive Impairments in Chronic Schizophrenia Patients
A randomized, double-blind sham-controlled trial of high frequency rTMS treatment for cognitive impairments in 120 chronic schizophrenia patients
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: 1. Clinical Trial: The study consists of 8 weeks of treatment. 2. 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
Age
18 - 60 years
Sex
MALE
Healthy Volunteers
No
Start Date
January 1, 2017
Primary Completion Date
October 30, 2018
Completion Date
November 30, 2018
Last Updated
May 1, 2019
120
ACTUAL participants
10 Hz treatment group
DEVICE
20 Hz treatment group
DEVICE
Control Group
DEVICE
Lead Sponsor
Beijing HuiLongGuan Hospital
NCT07455929
NCT06740383
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