Tardive DyskinesiaNCT02840760
Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
A study testing Repetitive Transcranial Magnetic Stimulation in people with Tardive Dyskinesia, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tardive Dyskinesia
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200030
Dengtang Liu, MD, +862164387250-73775, erliu110@126.com
About this study
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.
Read the 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.
- Conditions
- Tardive Dyskinesia
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- tardive dyskinesia., rTMS
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Stimulate the primary motor cortex for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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）. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Healthy control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in motor evoked potential(MEP)
Measured: 2 times (Before treatment,immediately after treatment)
Change from baseline in Abnormal Involuntary Movement Scale(AIMS）
Measured: 2 times (Before treatment,immediately after treatment)
Secondary outcomes (7)
Change from baseline in cortical silent period
Measured: 2 times (Before treatment,immediately after treatment)
Change from baseline in short interval intracortical inhibition(SICI）
Measured: 2 times (Before treatment,immediately after treatment)
Change from baseline in intracortical facilitation(ICF）
Measured: 2 times (Before treatment,immediately after treatment)
Change from baseline in Simpson-Angus Scale（SAS）
Measured: 2 times (Before treatment,immediately after treatment)
Change from baseline in Barnes Akathisia Rating Scale（BARS）
Measured: 2 times (Before treatment,immediately after treatment)
Change from baseline in Positive and Negative Syndrome Scale（PANSS）
Measured: 2 times (Before treatment,immediately after treatment)
Change from baseline in clinical global impression (CGI)
Measured: 2 times (Before treatment,immediately after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840760
- Sponsor's protocol ID
- 15ZR1435600
- Status last verified
- Jun 2017
- First submitted
- 19 Jul 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.
- ClinicalTrials.gov ID
- NCT02840760
- Acronym / sponsor ID
- 15ZR1435600
- Conditions
- Tardive Dyskinesia
- Keywords
- tardive dyskinesia., rTMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tardive dyskinesia group | Active comparator | Device: Repetitive Transcranial Magnetic Stimulationtardive 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）. |
| Healthy control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationStimulate the primary motor cortex for 2 weeks. | Device | tardive dyskinesia group |
Primary outcome
Change from baseline in motor evoked potential(MEP)
Time frame: 2 times (Before treatment,immediately after treatment)
Change from baseline in Abnormal Involuntary Movement Scale(AIMS）
Time frame: 2 times (Before treatment,immediately after treatment)
7 secondary outcomes
Change from baseline in cortical silent period
Time frame: 2 times (Before treatment,immediately after treatment)
Change from baseline in short interval intracortical inhibition(SICI）
Time frame: 2 times (Before treatment,immediately after treatment)
Change from baseline in intracortical facilitation(ICF）
Time frame: 2 times (Before treatment,immediately after treatment)
Change from baseline in Simpson-Angus Scale（SAS）
Time frame: 2 times (Before treatment,immediately after treatment)
Change from baseline in Barnes Akathisia Rating Scale（BARS）
Time frame: 2 times (Before treatment,immediately after treatment)
Change from baseline in Positive and Negative Syndrome Scale（PANSS）
Time frame: 2 times (Before treatment,immediately after treatment)
Change from baseline in clinical global impression (CGI)
Time frame: 2 times (Before treatment,immediately after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Tardive Dyskinesia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dengtang Liu (+86 21 64387250-73775, erliu110@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in motor evoked potential(MEP) (time frame: 2 times (Before treatment,immediately after treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.