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

June 5, 2021 updated by: Xiang Yang Zhang, Beijing HuiLongGuan Hospital

Influence of rTMS on Symptoms and Cognition in Patients With Psychiatric Disorders

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Clinical Trial：The study consists of 4 weeks of treatment.
  2. 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

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Chaohu, Anhui, China, 238000
        • Chaohu Hospital of Anhui medical unviersity
    • Guangdong
      • Zhongshan, Guangdong, China, 528400
        • Zhongshan Third People's Hospital
    • Hubei
      • Wuhan, Hubei, China, 100096
        • Wuhan Mental Health Center
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Ganzhou Third Hospital
    • Ningxia
      • Ning'an, Ningxia, China, 755100
        • Ningxia Mental Health Center
    • Shanxi
      • Xi'an, Shanxi, China, 710000
        • Xi'an Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: rTMS in schizophrenia patients
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
Device: rTMS in schizophrenia patients
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
SHAM_COMPARATOR: rTMS in schizophrenia Controls
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.
Device: rTMS in schizophrenia Controls
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.
ACTIVE_COMPARATOR: rTMS in major depressive disorders patients
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
Device: rTMS in major depressive disorders patients
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
SHAM_COMPARATOR: rTMS in major depressive disorders controls
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.
Device: rTMS in major depressive disorders controls
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptoms assessed on PANSS
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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)
Time Frame: 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect assessed on UKU
Time Frame: 4 weeks

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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing HuiLongGuan Hospital

Investigators

  • Principal Investigator: Xiang Y Zhang, MD,PhD, Institute of Psychology, Chinese Academy of Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

July 14, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (ACTUAL)

August 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 5, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASPsy2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data with be available on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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