Clinical trial NCT03774927: High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients
Official title: A Randomized, Double-blind Sham-controlled Trial of High Frequency rTMS for Cognitive Impairments in Chronic Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
rTMS
Lead sponsor: Beijing HuiLongGuan Hospital
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Repeatable Battery for the Assessment of Neuropsychological Status for cognition
timeFrame: 8 weeks
measure: Positive and Negative Syndrome Scale for clinical symptoms
timeFrame: 8 weeks
Secondary outcomes:
measure: Treatment Emergent Symptoms Scale for side effects
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hebei Province Veteran Psychiatric Hospital
name: Hengyong Guan, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.