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

NCT ID: NCT02840760

Last Updated: 2018-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Tardive Dyskinesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Stimulate the primary motor cortex for 2 weeks.

Healthy control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Repetitive Transcranial Magnetic Stimulation

Stimulate the primary motor cortex for 2 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dengtang Liu

Role: CONTACT

+86 21 64387250-73775

Facility Contacts

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Dengtang Liu, MD

Role: primary

+862164387250-73775

Other Identifiers

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15ZR1435600

Identifier Type: -

Identifier Source: org_study_id

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