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

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ClinicalTrials.gov Identifier: NCT02840760
Recruitment Status : Unknown
Verified June 2017 by Shanghai Mental Health Center.
Recruitment status was:  Recruiting
First Posted : July 21, 2016
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date February 26, 2018
Actual Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • Change from baseline in motor evoked potential(MEP) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  • Change from baseline in Abnormal Involuntary Movement Scale(AIMS) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • Change from baseline in cortical silent period [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  • Change from baseline in short interval intracortical inhibition(SICI) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  • Change from baseline in intracortical facilitation(ICF) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  • Change from baseline in Simpson-Angus Scale(SAS) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  • Change from baseline in Barnes Akathisia Rating Scale(BARS) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  • Change from baseline in Positive and Negative Syndrome Scale(PANSS) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  • Change from baseline in clinical global impression (CGI) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
Official Title  ICMJE Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tardive Dyskinesia
Intervention  ICMJE Device: Repetitive Transcranial Magnetic Stimulation
Stimulate the primary motor cortex for 2 weeks.
Study Arms  ICMJE
  • Active Comparator: tardive dyskinesia group
    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).
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation
  • No Intervention: Healthy control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 19, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840760
Other Study ID Numbers  ICMJE 15ZR1435600
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai Mental Health Center
Study Sponsor  ICMJE Shanghai Mental Health Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Mental Health Center
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP