Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from baseline in motor evoked potential(MEP)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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: Repetitive Transcranial Magnetic Stimulation (Device)
Healthy control group
Outcomes
Primary Outcomes
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 Outcomes
- Change from baseline in Barnes Akathisia Rating Scale（BARS）(2 times (Before treatment,immediately after treatment))
- Change from baseline in Simpson-Angus Scale（SAS）(2 times (Before treatment,immediately after treatment))
- Change from baseline in cortical silent period(2 times (Before treatment,immediately after treatment))
- Change from baseline in clinical global impression (CGI)(2 times (Before treatment,immediately after treatment))
- Change from baseline in short interval intracortical inhibition(SICI）(2 times (Before treatment,immediately after treatment))
- Change from baseline in intracortical facilitation(ICF）(2 times (Before treatment,immediately after treatment))
- Change from baseline in Positive and Negative Syndrome Scale（PANSS）(2 times (Before treatment,immediately after treatment))