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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • 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).
  • No Intervention: Healthy control group

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shanghai Mental Health Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Dengtang Liu, +86 21 64387250-73775, erliu110@126.com

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