High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Device: 20 Hz treatment group; Device: 10 Hz treatment group; Device: Control Group

• Registration Number: NCT03774927
• Lead Sponsor: Beijing HuiLongGuan Hospital

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

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-10-30
• Study Completion: 2018-11-30
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-28
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20 Hz treatment group	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.
10 Hz treatment group	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.
Control Group	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.

Primary Outcome Measures

Name	Time	Method
Repeatable Battery for the Assessment of Neuropsychological Status for cognition	8 weeks	cognitive performance
Positive and Negative Syndrome Scale for clinical symptoms	8 weeks	clinical symptoms

Secondary Outcome Measures

Name	Time	Method
Treatment Emergent Symptoms Scale for side effects	8 weeks	Side effect