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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 : Recruiting
First Posted : July 21, 2016
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Device: Repetitive Transcranial Magnetic Stimulation Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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).
Device: Repetitive Transcranial Magnetic Stimulation
Stimulate the primary motor cortex for 2 weeks.

No Intervention: Healthy control group



Primary Outcome Measures :
  1. Change from baseline in motor evoked potential(MEP) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  2. Change from baseline in Abnormal Involuntary Movement Scale(AIMS) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]

Secondary Outcome Measures :
  1. Change from baseline in cortical silent period [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  2. Change from baseline in short interval intracortical inhibition(SICI) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  3. Change from baseline in intracortical facilitation(ICF) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  4. Change from baseline in Simpson-Angus Scale(SAS) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  5. Change from baseline in Barnes Akathisia Rating Scale(BARS) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  6. Change from baseline in Positive and Negative Syndrome Scale(PANSS) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]
  7. Change from baseline in clinical global impression (CGI) [ Time Frame: 2 times (Before treatment,immediately after treatment) ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840760


Contacts
Contact: Dengtang Liu +86 21 64387250-73775 erliu110@126.com

Locations
China, Shanghai
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200030
Contact: Dengtang Liu, MD    +862164387250-73775    erliu110@126.com   
Sponsors and Collaborators
Shanghai Mental Health Center

Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT02840760     History of Changes
Other Study ID Numbers: 15ZR1435600
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shanghai Mental Health Center:
tardive dyskinesia.
rTMS

Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced