Clinical trial NCT02840760: Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
Official title: Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tardive Dyskinesia
Keywords: tardive dyskinesia.
rTMS
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in motor evoked potential(MEP)
timeFrame: 2 times (Before treatment,immediately after treatment)
measure: Change from baseline in Abnormal Involuntary Movement Scale(AIMS）
timeFrame: 2 times (Before treatment,immediately after treatment)
Secondary outcomes:
measure: Change from baseline in cortical silent period
timeFrame: 2 times (Before treatment,immediately after treatment)
measure: Change from baseline in short interval intracortical inhibition(SICI）
timeFrame: 2 times (Before treatment,immediately after treatment)
measure: Change from baseline in intracortical facilitation(ICF）
timeFrame: 2 times (Before treatment,immediately after treatment)
measure: Change from baseline in Simpson-Angus Scale（SAS）
timeFrame: 2 times (Before treatment,immediately after treatment)
measure: Change from baseline in Barnes Akathisia Rating Scale（BARS）
timeFrame: 2 times (Before treatment,immediately after treatment)
measure: Change from baseline in Positive and Negative Syndrome Scale（PANSS）
timeFrame: 2 times (Before treatment,immediately after treatment)
measure: Change from baseline in clinical global impression (CGI)
timeFrame: 2 times (Before treatment,immediately after treatment)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: