search
Back to results

Influence of rTMS on Symptoms and Cognitive Function in Patients With Psychiatric Disorders

Primary Purpose

Schizophrenia, Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rTMS in schizophrenia Controls
rTMS in schizophrenia patients
rTMS in major depressive disorders controls
rTMS in major depressive disorders patients
Sponsored by
Beijing HuiLongGuan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, smoking, rTMS, major depressive disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Chaohu Hospital of Anhui medical unviersity
  • Zhongshan Third People's Hospital
  • Wuhan Mental Health Center
  • Ganzhou Third Hospital
  • Ningxia Mental Health Center
  • Xi'an Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

rTMS in schizophrenia patients

rTMS in schizophrenia Controls

rTMS in major depressive disorders patients

rTMS in major depressive disorders controls

Arm Description

In 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

In 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.

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 4 consecutive weeks

In 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Side effect assessed on UKU
The Udvalg for Kliniske Under-sogelser (UKU) side effect rating scale is a clinician-rated assessment uses to capture the side effects of psychotropic drug doses. It consists three parts: The first part, the single symptom rating scale. The scoring level may varied on the individual items but the general scale remains the same principle: 0= not or doubtfully present, 1 = present to a mild degree, 2 = present to a moderate degree, 3 = present to a severe degree. The greater level indicate, the severe the symptom becomes. The second part is a global assessment, where as 0 refers to no effect and 3 represents side effects that interfere moderately with the patient's performance. The last component is a statement of the results that the patient's side effects have for following up the medication. The decision are listed as from 0, "no action", to 3, "discontinuation of drug or changes to another preparation". The larger the number appears, the greater demand of intervention.

Full Information

First Posted
July 14, 2019
Last Updated
June 5, 2021
Sponsor
Beijing HuiLongGuan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04055181
Brief Title
Influence of rTMS on Symptoms and Cognitive Function in Patients With Psychiatric Disorders
Official Title
Influence of rTMS on Symptoms and Cognition in Patients With Psychiatric Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (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
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
Detailed Description
OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency rTMS over left dorsolateral prefrontal cortex in the treatment of symptoms and cognitive functioning in 200 chronic patients with schizophrenia and 200 patients with major depressive disorders METHODS: Clinical Trial：The study consists of 4 weeks of treatment. Assess 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) or DSM-IV for depression, and repeatable battery for the assessment of neuropsychological status(RBANS).Patients are interviewed at screening, at at baseline, 4 weeks, 16 weeks. 2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at baseline, 4 weeks, and 16 weeks. 2.3 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, Major Depressive Disorder
Keywords
schizophrenia, smoking, rTMS, major depressive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS in schizophrenia patients
Arm Type
Active Comparator
Arm Description
In 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
Arm Title
rTMS in schizophrenia Controls
Arm Type
Sham Comparator
Arm Description
In 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.
Arm Title
rTMS in major depressive disorders patients
Arm Type
Active Comparator
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 4 consecutive weeks
Arm Title
rTMS in major depressive disorders controls
Arm Type
Sham Comparator
Arm Description
In 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.
Intervention Type
Device
Intervention Name(s)
rTMS in schizophrenia Controls
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS in schizophrenia patients
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
rTMS in major depressive disorders controls
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS in major depressive disorders patients
Intervention Description
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
Primary Outcome Measure Information:
Title
symptoms assessed on PANSS
Description
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.
Time Frame
4 weeks
Title
cognitive functioning assessed on RBANS
Description
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.
Time Frame
4 weeks
Title
major depressive disorders assessed on Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Side effect assessed on UKU
Description
The Udvalg for Kliniske Under-sogelser (UKU) side effect rating scale is a clinician-rated assessment uses to capture the side effects of psychotropic drug doses. It consists three parts: The first part, the single symptom rating scale. The scoring level may varied on the individual items but the general scale remains the same principle: 0= not or doubtfully present, 1 = present to a mild degree, 2 = present to a moderate degree, 3 = present to a severe degree. The greater level indicate, the severe the symptom becomes. The second part is a global assessment, where as 0 refers to no effect and 3 represents side effects that interfere moderately with the patient's performance. The last component is a statement of the results that the patient's side effects have for following up the medication. The decision are listed as from 0, "no action", to 3, "discontinuation of drug or changes to another preparation". The larger the number appears, the greater demand of intervention.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Y Zhang, MD,PhD
Organizational Affiliation
Institute of Psychology, Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaohu Hospital of Anhui medical unviersity
City
Chaohu
State/Province
Anhui
ZIP/Postal Code
238000
Country
China
Facility Name
Zhongshan Third People's Hospital
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528400
Country
China
Facility Name
Wuhan Mental Health Center
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
100096
Country
China
Facility Name
Ganzhou Third Hospital
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341000
Country
China
Facility Name
Ningxia Mental Health Center
City
Ning'an
State/Province
Ningxia
ZIP/Postal Code
755100
Country
China
Facility Name
Xi'an Mental Health Center
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data with be available on request
Citations:
PubMed Identifier
29486960
Citation
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.
Results Reference
background
PubMed Identifier
24211840
Citation
Prikryl 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.
Results Reference
background
PubMed Identifier
28638206
Citation
Huang 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.
Results Reference
background
PubMed Identifier
25650047
Citation
Zvolensky 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.
Results Reference
background
PubMed Identifier
28844559
Citation
Benadhira 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.
Results Reference
background

Learn more about this trial

Influence of rTMS on Symptoms and Cognitive Function in Patients With Psychiatric Disorders

We'll reach out to this number within 24 hrs