Influence of rTMS on Symptoms and Cognitive Function in Patients With Psychiatric Disorders
1 other identifier
interventional
800
1 country
6
Brief Summary
The investigators investigated the effects of high frequency (10Hz) repetitive transcranial magnetic stimulation (rTMS) on the symptoms and cognitive functioning in patients with psychiatric disorders
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Dec 2018
Shorter than P25 for not_applicable schizophrenia
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 14, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedJune 9, 2021
June 1, 2021
1.1 years
July 14, 2019
June 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
symptoms assessed on PANSS
The Positive and Negative Syndrome Scale is often shorted as PANSS. It is a well-characterized and well-applied measurement instrument that measures positive and negative syndromes, their differential and general severity of illness. The items on the PANSS are defined with increasing levels from 1 to 7, the greater the value appears, the severe the level is: 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate-severe, 6 = severe, and 7 = extreme. The PANSS score is finalized by summation of ratings across different items, the potential range for positive and negative scales are from 7 to 49 whereas the General Psychopathology Scale is ranged between 16 to 112.
4 weeks
cognitive functioning assessed on RBANS
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a test for identifying and characterizing abnormal cognitive decline in the elders and examining neuropsychological disorders for younger adults. The RBANS is comprised of five domains, which are Immediate Memory, Visuospatial /Constructional, Language, Attention and Delayed Memory. Each of the five index is based on two subtests except Delayed memory index consisting of four subtests. The score from each index is scaled by the age group with the scaled score mean to be 100 and standard deviation equals to 15, then the total RBANS scored is summed up of these indexes with the same normal mean and standard deviation. The lower the RBANS score the patient receives, the grave cognitive declination appears.
4 weeks
major depressive disorders assessed on Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
The classification of major depressive disorder has been updated in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorder (DSM-V). It is defined by the lifetime absence of mania and hypomania, as well as one or more major depressive episodes. DSM description includes the diagnostic classification, the diagnostic criteria sets and the descriptive text. The diagnostic classification represents the official list of mental disorder with diagnostic codes that used by all U.S. health care professionals. The diagnostic criteria, specifically, the criteria for major depressive disorder consists: five or more out of nine related symptoms, symptoms cause significant distress or impairment, episode has not attribute to any substance or medical condition, the absent of psychotic disorder, the absent of any manic or hypomanic episode. Last but not the least, the descriptive text provides information like diagnostic features, diagnostic measures and functional consequences.
4 weeks
Secondary Outcomes (1)
Side effect assessed on UKU
4 weeks
Study Arms (4)
rTMS in schizophrenia patients
ACTIVE COMPARATORIn active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks
rTMS in schizophrenia Controls
SHAM COMPARATORIn sham rTMS, all procedures were identical to 10Hz Schizophrenia group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
rTMS in major depressive disorders patients
ACTIVE COMPARATORIn 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 4 consecutive weeks
rTMS in major depressive disorders controls
SHAM COMPARATORIn sham rTMS, all procedures were identical to 10Hz depression group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
Interventions
all procedures were identical to "rTMS in schizophrenia patients" group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks
all procedures were identical to "rTMS in major depressive disorders patients" group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks
Eligibility Criteria
You may qualify if:
- For Schizophrenia Patients:
- Diagnosis of schizophrenia by two senior psychiatrists
- Between 18 and 60 years and Han Chinese
- Duration of symptoms at least 12 months
- With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of PANSS \< 24)
- Smoking
- For Major Depressive Disorder Patients:
- Diagnosis of Major depressive disorder by two senior psychiatrists
- Between 18 and 60 years and Han Chinese
- Duration of symptoms at least 12 months
- Smoking
You may not qualify if:
- 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, intracranial 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Chaohu Hospital of Anhui medical unviersity
Chaohu, Anhui, 238000, China
Zhongshan Third People's Hospital
Zhongshan, Guangdong, 528400, China
Wuhan Mental Health Center
Wuhan, Hubei, 100096, China
Ganzhou Third Hospital
Ganzhou, Jiangxi, 341000, China
Ningxia Mental Health Center
Ning’an, Ningxia, 755100, China
Xi'an Mental Health Center
Xi’an, Shanxi, 710000, China
Related Publications (5)
Kozak K, Sharif-Razi M, Morozova M, Gaudette EV, Barr MS, Daskalakis ZJ, Blumberger DM, George TP. Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls. Schizophr Res. 2018 Jul;197:441-443. doi: 10.1016/j.schres.2018.02.015. Epub 2018 Feb 24.
PMID: 29486960BACKGROUNDPrikryl R, Ustohal L, Kucerova HP, Kasparek T, Jarkovsky J, Hublova V, Vrzalova M, Ceskova E. Repetitive transcranial magnetic stimulation reduces cigarette consumption in schizophrenia patients. Prog Neuropsychopharmacol Biol Psychiatry. 2014 Mar 3;49:30-5. doi: 10.1016/j.pnpbp.2013.10.019. Epub 2013 Nov 6.
PMID: 24211840BACKGROUNDHuang W, Shen F, Zhang J, Xing B. Effect of Repetitive Transcranial Magnetic Stimulation on Cigarette Smoking in Patients with Schizophrenia. Shanghai Arch Psychiatry. 2016 Dec 25;28(6):309-317. doi: 10.11919/j.issn.1002-0829.216044.
PMID: 28638206BACKGROUNDZvolensky MJ, Bakhshaie J, Sheffer C, Perez A, Goodwin RD. Major depressive disorder and smoking relapse among adults in the United States: a 10-year, prospective investigation. Psychiatry Res. 2015 Mar 30;226(1):73-7. doi: 10.1016/j.psychres.2014.11.064. Epub 2014 Dec 9.
PMID: 25650047BACKGROUNDBenadhira R, Thomas F, Bouaziz N, Braha S, Andrianisaina PS, Isaac C, Moulier V, Januel D. A randomized, sham-controlled study of maintenance rTMS for treatment-resistant depression (TRD). Psychiatry Res. 2017 Dec;258:226-233. doi: 10.1016/j.psychres.2017.08.029. Epub 2017 Aug 18.
PMID: 28844559BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiang Y Zhang, MD,PhD
Institute of Psychology, Chinese Academy of Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 14, 2019
First Posted
August 13, 2019
Study Start
December 1, 2018
Primary Completion
December 30, 2019
Study Completion
January 30, 2020
Last Updated
June 9, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share
Data with be available on request