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Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

Primary Purpose

Schizophrenia, Metabolic Disturbance, Eating Behavior

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
accelerated theta burst stimulation
Sham stimulation
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, metabolic disturbance, cTBS, Event related potentials

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with schizophrenia in accordance with DSM-5
  • The course of the disease less then 2 years
  • Accepting antipsychotics treatment for less 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

Sites / Locations

  • Second Xiangya Hospital Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real stimulation

Sham stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of body weight
the change of participants weight
Change of body mass index
the change of participants BMI

Secondary Outcome Measures

Positive and Negative syndrome rating scale
Positive and Negative syndrome rating scale, from 30-210, higher score means worse symptoms.
Three Factor Eating Questionnaire
three domain regarding eating behavior, from 0-51, higher score means better.
Barrat impulsiveness scale
four domains regarding impulsiveness, from 26-104 higher score means higher impulse.
Self-Control Scale
five domains regarding self control ability, from 36-180 higher score means better self control.
Food picture stimulation Event-related potentials
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.

Full Information

First Posted
April 28, 2022
Last Updated
November 17, 2022
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05358899
Brief Title
Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia
Official Title
The Effect and Safety of Accelerated Continuous Theta-burst Stimulation on Metabolic Dysfunction in People With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Metabolic Disturbance, Eating Behavior, Transcranial Magnetic Stimulation
Keywords
schizophrenia, metabolic disturbance, cTBS, Event related potentials

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Quadro-blind clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The participants, care provider, investigator, and outcome assessor will be blind to the intervention except the treatment provider.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
accelerated theta burst stimulation
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of body weight
Description
the change of participants weight
Time Frame
from baseline to 6 weeks
Title
Change of body mass index
Description
the change of participants BMI
Time Frame
from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Positive and Negative syndrome rating scale
Description
Positive and Negative syndrome rating scale, from 30-210, higher score means worse symptoms.
Time Frame
from baseline to 6 weeks
Title
Three Factor Eating Questionnaire
Description
three domain regarding eating behavior, from 0-51, higher score means better.
Time Frame
from baseline to 6 weeks
Title
Barrat impulsiveness scale
Description
four domains regarding impulsiveness, from 26-104 higher score means higher impulse.
Time Frame
from baseline to 6 weeks
Title
Self-Control Scale
Description
five domains regarding self control ability, from 36-180 higher score means better self control.
Time Frame
from baseline to 6 weeks
Title
Food picture stimulation Event-related potentials
Description
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.
Time Frame
from baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renrong Wu, Prof
Phone
15874179855
Email
wurenrong@csu.edu.cn
Facility Information:
Facility Name
Second Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongyu Kang, MD
Phone
+86 13787142461
Email
kangdongyu@csu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data will be provided for scientific study only with the permission of the principle investigator.

Learn more about this trial

Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

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