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

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02840760
Collaborator
(none)
60
1
2
27
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Repetitive Transcranial Magnetic Stimulation
N/A

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
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
Actual Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in motor evoked potential(MEP) [2 times (Before treatment,immediately after treatment)]

  2. Change from baseline in Abnormal Involuntary Movement Scale(AIMS) [2 times (Before treatment,immediately after treatment)]

Secondary Outcome Measures

  1. Change from baseline in cortical silent period [2 times (Before treatment,immediately after treatment)]

  2. Change from baseline in short interval intracortical inhibition(SICI) [2 times (Before treatment,immediately after treatment)]

  3. Change from baseline in intracortical facilitation(ICF) [2 times (Before treatment,immediately after treatment)]

  4. Change from baseline in Simpson-Angus Scale(SAS) [2 times (Before treatment,immediately after treatment)]

  5. Change from baseline in Barnes Akathisia Rating Scale(BARS) [2 times (Before treatment,immediately after treatment)]

  6. Change from baseline in Positive and Negative Syndrome Scale(PANSS) [2 times (Before treatment,immediately after treatment)]

  7. Change from baseline in clinical global impression (CGI) [2 times (Before treatment,immediately after treatment)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200030

Sponsors and Collaborators

  • Shanghai Mental Health Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT02840760
Other Study ID Numbers:
  • 15ZR1435600
First Posted:
Jul 21, 2016
Last Update Posted:
Feb 26, 2018
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Shanghai Mental Health Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2018