rTMS on Appetite and Cognitive Function in Schizophrenia

NCT04714970 | Unknown

• 1 other identifier: WU2021TMS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; rTMS; Appetite; Cognitive Function

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change of fasting glucose

  Change from Baseline to 6days and 36days

• Change of fasting insulin level

  Change from Baseline to 6days and 36days

• Change of Triglyceride

  Change from Baseline to 6days and 36days

• Change of Total Cholesterol

  Change from Baseline to 6days and 36days

• Change of LDL

  Change from Baseline to 6days and 36days

Study Arms (2)

iTBS stimulation

EXPERIMENTAL

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

Sham stimulation

SHAM COMPARATOR

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

Interventions

iTBS DEVICE

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.

iTBS stimulation

Shame stimulation DEVICE

TMS coil vertical to the brain surface, with same protocol as iTBS

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead
• Shanghai Mental Health Center: collaborator

Study Sites (1)

Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Renrong Wu, Prof

  Central South University Psychiatry Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: April 20, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)