High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients
NCT ID: NCT03774927
Last Updated: 2019-05-01
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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COMPLETED
NA
120 participants
INTERVENTIONAL
2017-01-01
2018-11-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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10 Hz treatment group
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.
10 Hz treatment group
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.
20 Hz treatment group
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.
20 Hz treatment group
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.
Control Group
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.
Control Group
all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
Interventions
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10 Hz treatment group
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.
20 Hz treatment group
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.
Control Group
all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
MALE
No
Sponsors
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Beijing HuiLongGuan Hospital
OTHER
Responsible Party
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Xiang Yang Zhang
Professor
Principal Investigators
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Hengyong Guan, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hebei Province Veteran Psychiatric Hospital
References
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Dlabac-de Lange JJ, Liemburg EJ, Bais L, Renken RJ, Knegtering H, Aleman A. Effect of rTMS on brain activation in schizophrenia with negative symptoms: A proof-of-principle study. Schizophr Res. 2015 Oct;168(1-2):475-82. doi: 10.1016/j.schres.2015.06.018. Epub 2015 Jul 14.
Mogg A, Purvis R, Eranti S, Contell F, Taylor JP, Nicholson T, Brown RG, McLoughlin DM. Repetitive transcranial magnetic stimulation for negative symptoms of schizophrenia: a randomized controlled pilot study. Schizophr Res. 2007 Jul;93(1-3):221-8. doi: 10.1016/j.schres.2007.03.016. Epub 2007 May 2.
Wobrock T, Guse B, Cordes J, Wolwer W, Winterer G, Gaebel W, Langguth B, Landgrebe M, Eichhammer P, Frank E, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Malchow B, Schneider-Axmann T, Falkai P, Hasan A. Left prefrontal high-frequency repetitive transcranial magnetic stimulation for the treatment of schizophrenia with predominant negative symptoms: a sham-controlled, randomized multicenter trial. Biol Psychiatry. 2015 Jun 1;77(11):979-88. doi: 10.1016/j.biopsych.2014.10.009. Epub 2014 Oct 23.
Zhu C, Yao J, Guan H, Wu F, Xiu M. Moderating role of familial relationships in the efficacy of rTMS intervention on cognitive function in patients with schizophrenia. BMC Psychiatry. 2025 Oct 21;25(1):1010. doi: 10.1186/s12888-025-07251-y.
Su X, Zhao L, Shang Y, Chen Y, Liu X, Wang X, Xiu M, Yu H, Liu L. Repetitive transcranial magnetic stimulation for psychiatric symptoms in long-term hospitalized veterans with schizophrenia: A randomized double-blind controlled trial. Front Psychiatry. 2022 Sep 23;13:873057. doi: 10.3389/fpsyt.2022.873057. eCollection 2022.
Xiu MH, Guan HY, Zhao JM, Wang KQ, Pan YF, Su XR, Wang YH, Guo JM, Jiang L, Liu HY, Sun SG, Wu HR, Geng HS, Liu XW, Yu HJ, Wei BC, Li XP, Trinh T, Tan SP, Zhang XY. Cognitive Enhancing Effect of High-Frequency Neuronavigated rTMS in Chronic Schizophrenia Patients With Predominant Negative Symptoms: A Double-Blind Controlled 32-Week Follow-up Study. Schizophr Bull. 2020 Sep 21;46(5):1219-1230. doi: 10.1093/schbul/sbaa035.
Other Identifiers
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CASPsy1
Identifier Type: -
Identifier Source: org_study_id
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