The Effect of Repetitive Transcranial Magnetic Stimulation in Schizophrenia

NCT03736291 | Withdrawn DMC

• 1 other identifier: JunCai
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has been shown to improve symptoms in patients with schizophrenia, but the underlying neural mechanism is unknown.This study hypothesized that repetitive transcranial magnetic stimulation of the cerebellar vermis can alter the ciliary-related functional connections in schizophrenia, thereby improving negative symptoms, cognitive function, and emotional symptoms. Therefore, this study will firstly explore the difference in cerebellar functional connectivity between patients and healthy controls, and on this basis, patients undergo a resting state functional magnetic resonance scan before and after rTMS intervention in the cerebellar vermis, and observe the cerebellar function connection in the treatment. Before and after changes, analyze the relationship between these changes and clinical efficacy to explore the neural mechanisms of efficacy.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• FCS

  FCS (functional connectivity strength) value. The Pearson's correlation analysis was used to analyze the time series signals of the brain voxels, and the functional connection matrix model of each subject was established. The gray matter template is used to calculate the mean value of the functional connection between each brain voxel and other voxels, which is the FCS value of the voxel.

  4 weeks

Secondary Outcomes (1)

• PANSS

  4 weeks

Study Arms (2)

active rTMS

ACTIVE COMPARATOR

The Active rTMS: The magnetic head uses the Magro X100's "8"-shaped coil, and the intervention site is the cerebellar vermis (1 cm below the occipital carina). The stimulation intensity is gradually increased by the 80%-100% exercise threshold according to the patient's tolerance. The total number of stimulation pulses per day is 600, the basic frequency is 5 Hz, and one short burst stimulus is given every 200 milliseconds. In each short array, three single pulses with a frequency of 50 Hz are buried, and every 10 short bursts are stimulated for 8 s. A total of 200 short bursts of stimulation. Intervention once a day, 5 times a week, intervention for 2 weeks, a total of 10 times.

Device: Repetitive transcranial magnetic stimulation

sham rTMS

SHAM COMPARATOR

The sham rTMS: The sham stimulation method was to invert the "8" shaped coil, which was 180° to the scalp, and other intervention parameters were consistent with the study group.

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive neuromodulation technique that induces excitatory changes in the cerebral cortex stimulated by repeated pulsed magnetic fields on the scalp.

active rTMS; sham rTMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The patient met the diagnostic criteria for schizophrenia in DSM-IV;
• years old;
• Right handed;
• On stable doses of psychotropic medications.

You may not qualify if:

• DSM-IV diagnosis of other Axis I disorders；
• Contraindications to TMS or MRI；
• Patients receiving ECT (electro-convulsive therapy) in last 6months；
• Left-handedness。

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Jun Cai

  Shanghai Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 9, 2018
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share