rTMS on Appetite and Cognitive Function in Schizophrenia

Repetitive Transcranial Magnetic Stimulation on Appetite and Cognitive Function in Schizophrenia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Device: iTBS; Device: Shame stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Central South University

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iTBS stimulation; 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.	Device: iTBS; 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.
Sham Comparator: Sham stimulation; 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.	Device: Shame stimulation; TMS coil vertical to the brain surface, with same protocol as iTBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Appetite	Three-Factor Eating Questionnaire	Change from Baseline to 6days and 36days
Change of MCCB	The MATRICS™ Consensus Cognitive Battery	Change from Baseline to 6days and 36days
Change of ERP	Food picture ERP recorded by EEG	Change from Baseline to 6days and 36days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of fasting glucose	in mmol/l	Change from Baseline to 6days and 36days
Change of fasting insulin level	in mmol/l	Change from Baseline to 6days and 36days
Change of Triglyceride	in mmol/l	Change from Baseline to 6days and 36days
Change of Total Cholesterol	in mmol/l	Change from Baseline to 6days and 36days
Change of LDL	in mmol/l	Change from Baseline to 6days and 36days
Change of HDL	in mmol/l	Change from Baseline to 6days and 36days
Change of BMI	weight and height will be combined to report BMI in kg/m^2	Change from Baseline to 6days and 36days

Collaborators and Investigators

• Sponsor: Central South University
• Collaborators: Shanghai Mental Health Center
• Investigators: Principal Investigator: Renrong Wu, Prof, Central South University Psychiatry Department

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; rTMS; Cognitive Function; Appetite
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: WU2021TMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No