Back to resultsHigh Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
10 Hz treatment group
20 Hz treatment group
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, rTMS
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
10 Hz treatment group
20 Hz treatment group
Control Group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Repeatable Battery for the Assessment of Neuropsychological Status for cognition
cognitive performance
Positive and Negative Syndrome Scale for clinical symptoms
clinical symptoms
Secondary Outcome Measures
Treatment Emergent Symptoms Scale for side effects
Side effect
Full Information
NCT ID
NCT03774927
First Posted
December 11, 2018
Last Updated
April 28, 2019
Sponsor
Beijing HuiLongGuan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03774927
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing HuiLongGuan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Clinical Trial: The study consists of 8 weeks of treatment.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, rTMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 Hz treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
20 Hz treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
10 Hz treatment group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
20 Hz treatment group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control Group
Intervention Description
all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
Primary Outcome Measure Information:
Title
Repeatable Battery for the Assessment of Neuropsychological Status for cognition
Description
cognitive performance
Time Frame
8 weeks
Title
Positive and Negative Syndrome Scale for clinical symptoms
Description
clinical symptoms
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Treatment Emergent Symptoms Scale for side effects
Description
Side effect
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hengyong Guan, Doctor
Organizational Affiliation
Hebei Province Veteran Psychiatric Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data with be available on request
Citations:
PubMed Identifier
26187147
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.
Results Reference
background
PubMed Identifier
17478080
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.
Results Reference
result
PubMed Identifier
25582269
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.
Results Reference
result
PubMed Identifier
36213928
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.
Results Reference
derived
PubMed Identifier
32185388
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 Mar 17;46(5):1219-30. doi: 10.1093/schbul/sbaa035. Online ahead of print.
Results Reference
derived
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High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients
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