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

Primary Purpose

Tardive Dyskinesia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tardive Dyskinesia focused on measuring tardive dyskinesia., rTMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shanghai Mental Health Center, Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

tardive dyskinesia group

Healthy control group

Arm Description

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）.

Outcomes

Primary Outcome Measures

Change from baseline in motor evoked potential(MEP)
Change from baseline in Abnormal Involuntary Movement Scale(AIMS）

Secondary Outcome Measures

Change from baseline in cortical silent period
Change from baseline in short interval intracortical inhibition(SICI）
Change from baseline in intracortical facilitation(ICF）
Change from baseline in Simpson-Angus Scale（SAS）
Change from baseline in Barnes Akathisia Rating Scale（BARS）
Change from baseline in Positive and Negative Syndrome Scale（PANSS）
Change from baseline in clinical global impression (CGI)

Full Information

First Posted
July 19, 2016
Last Updated
February 22, 2018
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02840760
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia
Keywords
tardive dyskinesia., rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tardive dyskinesia group
Arm Type
Active Comparator
Arm Description
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）.
Arm Title
Healthy control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
Stimulate the primary motor cortex for 2 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in motor evoked potential(MEP)
Time Frame
2 times (Before treatment,immediately after treatment)
Title
Change from baseline in Abnormal Involuntary Movement Scale(AIMS）
Time Frame
2 times (Before treatment,immediately after treatment)
Secondary Outcome Measure Information:
Title
Change from baseline in cortical silent period
Time Frame
2 times (Before treatment,immediately after treatment)
Title
Change from baseline in short interval intracortical inhibition(SICI）
Time Frame
2 times (Before treatment,immediately after treatment)
Title
Change from baseline in intracortical facilitation(ICF）
Time Frame
2 times (Before treatment,immediately after treatment)
Title
Change from baseline in Simpson-Angus Scale（SAS）
Time Frame
2 times (Before treatment,immediately after treatment)
Title
Change from baseline in Barnes Akathisia Rating Scale（BARS）
Time Frame
2 times (Before treatment,immediately after treatment)
Title
Change from baseline in Positive and Negative Syndrome Scale（PANSS）
Time Frame
2 times (Before treatment,immediately after treatment)
Title
Change from baseline in clinical global impression (CGI)
Time Frame
2 times (Before treatment,immediately after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dengtang Liu
Phone
+86 21 64387250-73775
Email
erliu110@126.com
Facility Information:
Facility Name
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dengtang Liu, MD
Phone
+862164387250-73775
Email
erliu110@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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