NCT02840760

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 26, 2018

Status Verified

June 1, 2017

Enrollment Period

2.2 years

First QC Date

July 19, 2016

Last Update Submit

February 22, 2018

Conditions

Tardive Dyskinesia

Keywords

tardive dyskinesia.rTMS

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Study Arms (2)

tardive dyskinesia group

ACTIVE COMPARATOR

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

Healthy control group

NO INTERVENTION

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

Stimulate the primary motor cortex for 2 weeks.

tardive dyskinesia group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-InducedDyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Dengtang Liu

CONTACT

+86 21 64387250-73775erliu110@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 21, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 26, 2018

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)