search
Back to results

rTMS on Appetite and Cognitive Function in Schizophrenia

Primary Purpose

Schizophrenia

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
iTBS
Shame stimulation
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, rTMS, Appetite, Cognitive Function

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with schizophrenia in accordance with DSM-5
  • Commorbid with significant weight gain after antipsychotics
  • Informed Consent

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

  • Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

iTBS stimulation

Sham stimulation

Arm Description

The participants randomized into experimental group will receive iTBS stimulation of dlPFC 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.

The participants randomized intoSham group will receive Sham stimulation, as the coil vertical to the brain surface, 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.

Outcomes

Primary Outcome Measures

Change of Appetite
Three-Factor Eating Questionnaire
Change of MCCB
The MATRICS™ Consensus Cognitive Battery
Change of ERP
Food picture ERP recorded by EEG

Secondary Outcome Measures

Change of fasting glucose
in mmol/l
Change of fasting insulin level
in mmol/l
Change of Triglyceride
in mmol/l
Change of Total Cholesterol
in mmol/l
Change of LDL
in mmol/l
Change of HDL
in mmol/l
Change of BMI
weight and height will be combined to report BMI in kg/m^2

Full Information

First Posted
January 13, 2021
Last Updated
November 14, 2022
Sponsor
Central South University
Collaborators
Shanghai Mental Health Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04714970
Brief Title
rTMS on Appetite and Cognitive Function in Schizophrenia
Official Title
Repetitive Transcranial Magnetic Stimulation on Appetite and Cognitive Function in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
Collaborators
Shanghai Mental Health Center

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
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rTMS, using iTBS pattern, on prevention and treatment for elevated appetite and cognitive deficiency in individual with schizophrenia.
Detailed Description
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. The cognitive function deficit has also been a major symptom for schizophrenia. However, metabolic dysfunction could further impair the cognition. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of rTMS, using iTBS pattern, on prevention of the elevated appetite and cognitive deficiency in individual with schizophrenia. The intervention will last for 5 continuous days and the follow-ups are scheduled at baseline, 6days and 36days. The primary outcomes include the change of MCCB score, TFEQ score and EEG data. Secondary outcomes include the change of serum metabolic indexes and anthropometry indexes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, rTMS, Appetite, Cognitive Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iTBS stimulation
Arm Type
Experimental
Arm Description
The participants randomized into experimental group will receive iTBS stimulation of dlPFC 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
The participants randomized intoSham group will receive Sham stimulation, as the coil vertical to the brain surface, 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.
Intervention Type
Device
Intervention Name(s)
iTBS
Intervention Description
Intermittent theta burst stimulation (iTBS) on left dlPFC. 90% RMT, 50Hz within train and 5Hz train for 2 second and rest for 8 second. 600 train and 200 second in total.
Intervention Type
Device
Intervention Name(s)
Shame stimulation
Intervention Description
TMS coil vertical to the brain surface, with same protocol as iTBS
Primary Outcome Measure Information:
Title
Change of Appetite
Description
Three-Factor Eating Questionnaire
Time Frame
Change from Baseline to 6days and 36days
Title
Change of MCCB
Description
The MATRICS™ Consensus Cognitive Battery
Time Frame
Change from Baseline to 6days and 36days
Title
Change of ERP
Description
Food picture ERP recorded by EEG
Time Frame
Change from Baseline to 6days and 36days
Secondary Outcome Measure Information:
Title
Change of fasting glucose
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
Change of fasting insulin level
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
Change of Triglyceride
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
Change of Total Cholesterol
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
Change of LDL
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
Change of HDL
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
Change of BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
Change from Baseline to 6days and 36days

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 with schizophrenia in accordance with DSM-5 Commorbid with significant weight gain after antipsychotics Informed Consent 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renrong Wu, Prof
Organizational Affiliation
Central South University Psychiatry Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

rTMS on Appetite and Cognitive Function in Schizophrenia

We'll reach out to this number within 24 hrs