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

Tardive Dyskinesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02840760
• Other study ID #: 15ZR1435600
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2016
• Last updated: February 22, 2018
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Shanghai Mental Health Center
• Contact: Dengtang Liu
• Phone: +86 21 64387250-73775
• Email: erliu110[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesias
• Tardive Dyskinesia

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
Stimulate the primary motor cortex for 2 weeks.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in motor evoked potential(MEP)		2 times (Before treatment,immediately after treatment)
Primary	Change from baseline in Abnormal Involuntary Movement Scale(AIMS)		2 times (Before treatment,immediately after treatment)
Secondary	Change from baseline in cortical silent period		2 times (Before treatment,immediately after treatment)
Secondary	Change from baseline in short interval intracortical inhibition(SICI)		2 times (Before treatment,immediately after treatment)
Secondary	Change from baseline in intracortical facilitation(ICF)		2 times (Before treatment,immediately after treatment)
Secondary	Change from baseline in Simpson-Angus Scale(SAS)		2 times (Before treatment,immediately after treatment)
Secondary	Change from baseline in Barnes Akathisia Rating Scale(BARS)		2 times (Before treatment,immediately after treatment)
Secondary	Change from baseline in Positive and Negative Syndrome Scale(PANSS)		2 times (Before treatment,immediately after treatment)
Secondary	Change from baseline in clinical global impression (CGI)		2 times (Before treatment,immediately after treatment)