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

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 Overview

• Status: Unknown
• Conditions: Tardive Dyskinesia
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in motor evoked potential(MEP)	2 times (Before treatment,immediately after treatment)
Change from baseline in Abnormal Involuntary Movement Scale(AIMS）	2 times (Before treatment,immediately after treatment)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in cortical silent period	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 Simpson-Angus Scale（SAS）	2 times (Before treatment,immediately after treatment)
Change from baseline in Barnes Akathisia Rating Scale（BARS）	2 times (Before treatment,immediately after treatment)
Change from baseline in Positive and Negative Syndrome Scale（PANSS）	2 times (Before treatment,immediately after treatment)
Change from baseline in clinical global impression (CGI)	2 times (Before treatment,immediately after treatment)

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (ESTIMATE): July 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: rTMS; tardive dyskinesia.
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesia, Drug-Induced; Dyskinesias; Tardive Dyskinesia
• Other Study ID Numbers: 15ZR1435600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO