Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.

Not Applicable

• Conditions: Tardive Dyskinesia
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT02840760
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

The purpose of this study is to explore the therapeutic effect and mechanism of transcranial magnetic stimulation (rTMS) in the treatment of the tardive dyskinesia.

Detailed Description

The study was a parallel control design trial for 2 weeks. Patients with schizophrenia were treated with 10-Hz rTMS on left motor cortex (added to the ongoing treatment). Clinical symptoms and MEP were assessment before and after rTMS treatment.

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-21
• Study Start: 2016-09
• Status Verified: 2017-06
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The diagnosis of schizophrenia according to DSM-IV；
• At least two item of Abnormal Involuntary Movement Scale（AIMS） must be 2 points or higher
• these symptoms are not from Parkinson，tourette's syndrome,huntington disease
• Signed an informed consent

Exclusion Criteria

• rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure
• patients to be diagnosed according to DSM-IV for substance abused, development delayed
• current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines
• Acute risk of suicide and impulse
• history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG
• pregnant and lactant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tardive dyskinesia group	Repetitive Transcranial Magnetic Stimulation	tardive dyskinesia group will be delivered at an intensity that is 80% of the resting motor threshold (RMT). Stimulation will be delivered at 10 Hz with 60 stimulation trains of 30 stimuli each (i.e., 1800 stimuli) and an intertrain interval of 12 sec in primary motor cortex（M1）.

Primary Outcome Measures

Name	Time	Method
Change from baseline in motor evoked potential(MEP)	2 times (Before treatment,immediately after treatment)
Change from baseline in Abnormal Involuntary Movement Scale(AIMS）	2 times (Before treatment,immediately after treatment)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in clinical global impression (CGI)	2 times (Before treatment,immediately after treatment)
Change from baseline in Barnes Akathisia Rating Scale（BARS）	2 times (Before treatment,immediately after treatment)
Change from baseline in Simpson-Angus Scale（SAS）	2 times (Before treatment,immediately after treatment)
Change from baseline in cortical silent period	2 times (Before treatment,immediately after treatment)
Change from baseline in short interval intracortical inhibition(SICI）	2 times (Before treatment,immediately after treatment)
Change from baseline in intracortical facilitation(ICF）	2 times (Before treatment,immediately after treatment)
Change from baseline in Positive and Negative Syndrome Scale（PANSS）	2 times (Before treatment,immediately after treatment)

Trial Locations

Locations (1)

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China