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High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774927
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Xiang Yang Zhang, 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

Condition or disease Intervention/treatment Phase
Schizophrenia Device: 10 Hz treatment group Device: 20 Hz treatment group Device: Control Group Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Sham-controlled Trial of High Frequency rTMS for Cognitive Impairments in Chronic Schizophrenia Patients
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 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.
Device: 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.

Experimental: 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.
Device: 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.

Sham Comparator: 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.
Device: Control Group
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 :
  1. Repeatable Battery for the Assessment of Neuropsychological Status for cognition [ Time Frame: 8 weeks ]
    cognitive performance

  2. Positive and Negative Syndrome Scale for clinical symptoms [ Time Frame: 8 weeks ]
    clinical symptoms


Secondary Outcome Measures :
  1. Treatment Emergent Symptoms Scale for side effects [ Time Frame: 8 weeks ]
    Side effect



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774927


Sponsors and Collaborators
Beijing HuiLongGuan Hospital
Investigators
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Principal Investigator: Hengyong Guan, Doctor Hebei Province Veteran Psychiatric Hospital
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiang Yang Zhang, Professor, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT03774927    
Other Study ID Numbers: CASPsy1
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data with be available on request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:
schizophrenia
rTMS
Additional relevant MeSH terms:
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Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders