Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

November 17, 2022 updated by: Renrong Wu, Central South University

The Effect and Safety of Accelerated Continuous Theta-burst Stimulation on Metabolic Dysfunction in People With Schizophrenia

cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals with schizophrenia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Second Xiangya Hospital Central South University
        • Contact:

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with schizophrenia in accordance with DSM-5
  • BMI over 24
  • Accepting antipsychotics stable treatment for more then 2 months

Exclusion Criteria:

  • Diagnosed with other mental disease in accordance with DSM-5
  • Comorbid with other severe physiological disease
  • Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
  • Drug or alcohol abuse
  • Pregnant or lactating Contraindication to rTMS

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real stimulation
Participants in the real stimulation group will receive accelerated cTBS with 1800 stimulation per session for 10 consecutive days, 5 sessions per day with a gap at least one hour, 50 sessions in total. The stimulation will be conducted at left M1 area.
Device: accelerated theta burst stimulation
cTBS was administered at 80% of each participant's M1 area in a burst-firing pattern (3 pulses at 50 Hz) with a repetition frequency of 5 Hz (200 ms intervals). During each session, participants received 1800 pulses (120 s).
Sham Comparator: Sham stimulation
Participants in the sham stimulation group will receive the stimulation with coil vertical to the surface with other settings same as the real stimulation group.
Device: Sham stimulation
Similar process with the accelerated theta burst stimulation with the coil 90 degrees tilted to the surface of the scalp, which could produce identical sound and vibration while avoiding real magnetic stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of body weight
Time Frame: from baseline to 6 weeks
the change of participants weight
from baseline to 6 weeks
Change of body mass index
Time Frame: from baseline to 6 weeks
the change of participants BMI
from baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative syndrome rating scale
Time Frame: from baseline to 6 weeks
Positive and Negative syndrome rating scale, from 30-210, higher score means worse symptoms.
from baseline to 6 weeks
Three Factor Eating Questionnaire
Time Frame: from baseline to 6 weeks
three domain regarding eating behavior, from 0-51, higher score means better.
from baseline to 6 weeks
Barrat impulsiveness scale
Time Frame: from baseline to 6 weeks
four domains regarding impulsiveness, from 26-104 higher score means higher impulse.
from baseline to 6 weeks
Self-Control Scale
Time Frame: from baseline to 6 weeks
five domains regarding self control ability, from 36-180 higher score means better self control.
from baseline to 6 weeks
Food picture stimulation Event-related potentials
Time Frame: from baseline to 6 weeks
Several components of event-related potentials were analyzed regarding various cognitive processes. The data were analyzed using previously widely used pipelines to extract the characters of ERP components, for example, P3 and LPP, and compare its difference within groups and between groups through time. ERP analysis will be conducted using EEGLAB and FieldTrip in MATLAB, and statistic analysis will be conducted using R studio and SPSS.
from baseline to 6 weeks

Collaborators and Investigators

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

Sponsor

Central South University

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)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wu2022acTBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data will be provided for scientific study only with the permission of the principle investigator.

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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