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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02840760
Other study ID # 15ZR1435600
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
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Completed NCT02291861 - Addressing Involuntary Movements in Tardive Dyskinesia Phase 3
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Completed NCT02198794 - Reducing Involuntary Movements in Participants With Tardive Dyskinesia Phase 3
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Recruiting NCT06011408 - Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes N/A
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Terminated NCT00917293 - Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia Phase 2
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Terminated NCT02524886 - Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia N/A
Completed NCT02195700 - Aim to Reduce Movements in Tardive Dyskinesia Phase 2/Phase 3
Completed NCT02736955 - Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia Phase 3
Completed NCT03497013 - Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia N/A
Withdrawn NCT01908452 - Pyridoxal Kinase Activity in Tardive Dyskinesia Phase 3