Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

NCT05358899 | Unknown

• 1 other identifier: wu2022acTBS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Metabolic Disturbance; Eating Behavior; Transcranial Magnetic Stimulation

Keywords

schizophrenia; metabolic disturbance; cTBS; Event related potentials

Outcome Measures

Primary Outcomes (2)

• Change of body weight

  the change of participants weight

  from baseline to 6 weeks

• Change of body mass index

  the change of participants BMI

  from baseline to 6 weeks

Secondary Outcomes (5)

• Positive and Negative syndrome rating scale

  from baseline to 6 weeks

• Three Factor Eating Questionnaire

  from baseline to 6 weeks

• Barrat impulsiveness scale

  from baseline to 6 weeks

• Self-Control Scale

  from baseline to 6 weeks

• Food picture stimulation Event-related potentials

  from baseline to 6 weeks

Study Arms (2)

Real stimulation

EXPERIMENTAL

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

Sham stimulation

SHAM COMPARATOR

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

Interventions

accelerated theta burst stimulation DEVICE

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).

Real stimulation

Sham stimulation DEVICE

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.

Sham stimulation

Eligibility Criteria

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

You may qualify if:

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

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

Study Sites (1)

Second Xiangya Hospital Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Feeding Behavior

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior, Animal; Behavior

Central Study Contacts

Renrong Wu, Prof

CONTACT

15874179855; wurenrong@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, care provider, investigator, and outcome assessor will be blind to the intervention except the treatment provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Quadro-blind clinical trial

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

CN (1)