The Mid-term Effect of Repeated Transcranial Magnetic Stimulation on Schizophrenia

NCT03940898 | Completed

• 1 other identifier: JCai
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Medications have a poor effect on negative symptoms and cognitive function in schizophrenia. In the past, most of the studies on repetitive transcranial magnetic stimulation intervention in patients with schizophrenia used conventional stimulation sites and patterns, and the intervention effect was still controversial. A few studies have achieved positive results with the new stimulation model (TBS model) and the therapeutic target (cerebellar vermis), but the follow-up period did not exceed 2 weeks, and no similar studies have emerged in China. Therefore, this study hypothesized that the TBS-mode rTMS intervention in the cerebellar vermis can improve the negative symptoms, cognitive function, and depressive symptoms of schizophrenia, and the efficacy can be maintained.

Conditions

Schizophrenia

Keywords

Repetitive transcranial magnetic stimulation; Schizophrenia; Cerebellar vermis; Negative symptoms; Depressive symptoms; Cognitive function; Follow-up study

Outcome Measures

Primary Outcomes (1)

• PANSS-N

  The efficacy of negative symptoms was assessed based on the patient's score changes on the PANSS（Positive and Negative Syndrome Scale） negative symptom subscale. PANSS is a relatively mature assessment tool commonly used in clinical research to assess the severity of schizophrenia symptoms. It consists of a positive symptom subscale (7 items), a negative symptom subscale (7 items) and a general psychopathological symptom subscale (16 items), a total of 30 items.Each item has specific definitions and operational grading criteria. It is divided into 7 grades according to the level of psychopathology (1\~7 points). The higher the score, the heavier the symptoms. The total score of PANSS is 30- 210 points, the positive symptom subscale and the negative symptom subscale are 7-49 points, and the general psychopathological symptoms subscale is 16 to 112 points.

  24 weeks

Secondary Outcomes (2)

• MCCB

  24 weeks

• HAMD-24

  24 weeks

Study Arms (2)

study group-active rTMS

ACTIVE COMPARATOR

Participants in the study group received 100%MT(motor threshold) repetitive transcranial magnetic stimulation with the intermittent theta burst stimulation paradigm.

Device: repetitive transcranial magnetic stimulation

control group-shame rTMS

SHAM COMPARATOR

Participants in the control group received rTMS pseudo-stimulation intervention. The stimulation head was inverted by 180 degrees or 90 degrees according to the model of the stimulation device to achieve pseudo-stimulation and the remaining stimulation parameters were consistent with the study group.

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation DEVICE

There are two types of stimulation equipment, one is the transcranial magnetic stimulator model Magpro X100 produced by Danish Medtronic, and the other is the CCY-I TMS stimulator produced by Wuhan Eride, model B9076. The stimulating magnetic head uses an "8" shaped coil, and the stimulation site is the cerebellar vermis (ie, 1 cm below the occipital bulge), and the stimulation intensity is 100% of the motor threshold.The base frequency of the iTBS mode is 5 Hz, and one short burst stimulus occurs every 200 milliseconds. In each short array, three single pulses with a frequency of 50 Hz are buried, and each 10 short burst stimulation intervals are 8 seconds, for a total of 200 short burst stimulations. The total number of stimulation pulses is 600 per day.It takes 3 minutes and 20 seconds to complete one intervention. All participants were intervened once a day for 5 times a week for 2 weeks for a total of 10 times.

control group-shame rTMS; study group-active rTMS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• the patient met the diagnostic criteria for schizophrenia in ICD-10;
• years old;
• Right handed;
• The current condition is stable, and the types and doses of antipsychotic drugs are unchanged;
• In the PANSS scale, the score of Pl, P3, P5, P6, and G9 is not more than 5 points, and the score of P2 is not more than 4 points;

You may not qualify if:

• In addition to schizophrenia, patients with other mental illnesses；
• Contraindications to rTMS;
• Patients receiving ECT(electro-convulsive therapy) in last month;
• Pregnant or lactating woman.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Schizophrenia; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

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: April 29, 2019
• First Posted: May 7, 2019
• Study Start: July 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)