Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

Sponsor

Central South University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05358899

Collaborator

(none)

Enrollment

Arms

9.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Metabolic Disturbance Eating Behavior Cognitive Deficit	Device: accelerated theta burst stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Quadro-blind clinical trialRandomized Quadro-blind clinical trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The participants, care provider, investigator, and outcome assessor will be blind to the intervention except the treatment provider.

Primary Purpose:

Treatment

Official Title:

The Effect and Safety of Accelerated Continuous Theta-burst Stimulation on Metabolic Dysfunction in People With Schizophrenia

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Real stimulation 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 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).
Sham Comparator: Sham stimulation 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: accelerated theta burst stimulation 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).

Arm

Intervention/Treatment

Experimental: Real stimulation

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

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).

Sham Comparator: Sham stimulation

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: accelerated theta burst stimulation

Outcome Measures

Primary Outcome Measures

Change of body weight [from baseline to 6 weeks]
the change of participants weight
Change of body mass index [from baseline to 6 weeks]
the change of participants BMI

Secondary Outcome Measures

The MATRICS™ Consensus Cognitive Battery [from baseline to 6 weeks]
The MATRICS™ Consensus Cognitive Battery
Positive and Negative syndrome rating scale [from baseline to 6 weeks]
Positive and Negative syndrome rating scale, from 30-210, higher score means worse symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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