Tardive DyskinesiaNCT03497013
Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia
A study testing Active tDCS in people with Tardive Dyskinesia, run by Suzhou Psychiatric Hospital at 2 sites in China.
Trial summary
The aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tardive Dyskinesia
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesChina
- Study dates
- 31 Jul 2017to 11 Aug 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right-handed;
- meeting the diagnosis of schizophrania;
- had been receiving antipsychotic drugs for at least 12 months;
- at least one AIMS item rated(moderate) or at least two AIMS items rated ≥2(mild);
- All patients volunteered to participate in this study.
Who cannot join
- organic disorder that could cause movement disorders, mental retardation,and a history of substance dependence(except nicotine);
- with serious physical illness(e.g.severe cardiovascular diseases);
- with color blindness/weakness, stuttering, deafness.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Suzhou Psychiatric Hospital
Suzhou, Jiangsu, 215137
Suzhou
Suzhou, Jiangsu, 215237
About this study
Official title: Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive dyskinesia_a Randomized, Double-blind, Sham-controlled Trial
The aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD).
Read the detailed description
This study is a randomized, double-blind, sham-controlled clinical trial. 60 patients with TD were randomly allocated to active (n=30) or sham tDCS groups (n=30). All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). Abnormal Involuntary Movements Scale (AIMS), Tardive Dyskinesia Rating Scale (TDRS), Assessment of Negative Symptoms(SANS), the Positive and Negative symptom scale(PANSS), and the Cambridge Neuropsychological Test Automatic Battery (CANTAB) were assessed in patients. All evaluations were scored at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks. Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment.
- Conditions
- Tardive Dyskinesia
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- transcranial Direct Current Stimulation, Randomized Controlled Trial, Schizophrenia, Tardive Dyskinesia, Abnormal Involuntary Movements Scale, Tardive Dyskinesia Rating Scale, Cognition
- Medical subject headings
- Tardive Dyskinesia, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment).
Sham tDCSDevice
For sham stimulation, the device was set to turn off after 30 seconds(study model).
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). Receives: Device: Active tDCS |
| Sham tDCS | Sham comparator | For sham stimulation, the device was set to turn off after 30 seconds(study model). Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal Involuntary Movements Scale
The primary outcome measure was the severity of TD symptoms, which was measured by the AIMS total score(the sum of items 1-7).The range for subscale scores(items1-7) is between 0-28 scores and the higher values represent a worse outcome.
Measured: Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks
Secondary outcomes (5)
Tardive Dyskinesia Rating Scale
The severity of TD symptoms were also measured by the total TDRS score and the orofacial dyskinesia subscale scores, trunk and limb dyskinesia subscale scores. The range for TDRS total score is between 44-264 scores and the orofacial dyskinesia subscale scores are between16-96 scores , the trunk and limb dyskinesia subscale scores are between 24-144 scores.The higher values represent a worse outcome.
Measured: Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks
Safety and Tolerabilit
Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment. The questionnaire contained rating scales regarding the presence and severity of headache, difficulties in concentrating, acute mood changes, visual perceptual changes and any discomforting sensation like pain, tingling, itching or burning under the electrodes.
Measured: We assessed the side affects during and after tDCS.
Scale for the Assessment of Negative Symptoms
Negative symptoms were assessed with SANS. The range for SANS total scores is between 0-120 scores and the higher values represent a worse outcome.
Measured: Change from baseline SANS total scores at 5 weeks
Positive and Negative symptom scale
Psychopathology was measured by the total PANSS score and the positive, negative, and general psychopathology subscale scores. The range for PANSS total score is between 30-210 scores and the positive subscale scores are between 7-49 scores and the negative subscale scores are between 7-49 scores and the general psychopathology total scores are between 16-112 scores.
Measured: Change from baseline PANSS total scores at 5 weeks
Cambridge Neuropsychological Test Automatic Battery
Each patient was given a series of computerized tests from the Cambridge Neuropsychological Test Automated Battery. The language-independent tests and touch screen technology deliver rapid and non-invasive cognitive assessment. Executive and memory function were assessed with the following three tasks:The Pattern Recognition Memory (PRM), Intra/Extradimensional Set Shift (IED), and Spatial Working Memory.
Measured: Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start31 Jul 2017
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Psychiatric Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang-Dong Du, Suzhou Psychiatric Hospital
- Investigators
- Guangzhong Yin, MD, Study chair, Suzhou Guangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497013
- Sponsor's protocol ID
- SS201752
- Other IDs
- Szzx201509, SS201752
- Status last verified
- Aug 2022
- First submitted
- 3 Apr 2018
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Xia X, Zhao X, Yang R, Wu Y, Liu J, Lyu X, Li Z, Zhang G, Du X. Efficacy and safety of Transcranial Direct Current Stimulation (tDCS) on cognitive function in chronic schizophrenia with Tardive Dyskinesia (TD): a randomized, double-blind, sham-controlled, clinical trial. BMC Psychiatry. 2023 Aug 24;23(1):623. doi: 10.1186/s12888-023-05112-0.
PubMed 37620825
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive dyskinesia_a Randomized, Double-blind, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT03497013
- Acronym / sponsor ID
- SS201752
- Conditions
- Tardive Dyskinesia
- Keywords
- transcranial Direct Current Stimulation, Randomized Controlled Trial, Schizophrenia, Tardive Dyskinesia, Abnormal Involuntary Movements Scale, Tardive Dyskinesia Rating Scale, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Suzhou Psychiatric HospitalUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 13 Apr 2018 (actual)
- 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 aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD).
Detailed description
This study is a randomized, double-blind, sham-controlled clinical trial. 60 patients with TD were randomly allocated to active (n=30) or sham tDCS groups (n=30). All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). Abnormal Involuntary Movements Scale (AIMS), Tardive Dyskinesia Rating Scale (TDRS), Assessment of Negative Symptoms(SANS), the Positive and Negative symptom scale(PANSS), and the Cambridge Neuropsychological Test Automatic Battery (CANTAB) were assessed in patients. All evaluations were scored at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks. Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD).
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCSAll patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). |
| Sham tDCS | Sham comparator | Device: Sham tDCSFor sham stimulation, the device was set to turn off after 30 seconds(study model). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Right-handed;
- meeting the diagnosis of schizophrania;
- had been receiving antipsychotic drugs for at least 12 months;
- at least one AIMS item rated(moderate) or at least two AIMS items rated ≥2(mild);
- All patients volunteered to participate in this study.
Key exclusion criteria (3 listed)
- organic disorder that could cause movement disorders, mental retardation,and a history of substance dependence(except nicotine);
- with serious physical illness(e.g.severe cardiovascular diseases);
- with color blindness/weakness, stuttering, deafness.
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 |
|---|---|---|
| Active tDCSAll patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). | Device | Active tDCS |
| Sham tDCSFor sham stimulation, the device was set to turn off after 30 seconds(study model). | Device | Sham tDCS |
Primary outcome
Abnormal Involuntary Movements Scale
Time frame: Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks
The primary outcome measure was the severity of TD symptoms, which was measured by the AIMS total score(the sum of items 1-7).The range for subscale scores(items1-7) is between 0-28 scores and the higher values represent a worse outcome.
5 secondary outcomes
Tardive Dyskinesia Rating Scale
Time frame: Change from baseline TDRS total scores at 3 weeks and 5 weeks and 7 weeks
Safety and Tolerabilit
Time frame: We assessed the side affects during and after tDCS.
Scale for the Assessment of Negative Symptoms
Time frame: Change from baseline SANS total scores at 5 weeks
Positive and Negative symptom scale
Time frame: Change from baseline PANSS total scores at 5 weeks
Cambridge Neuropsychological Test Automatic Battery
Time frame: Change from baseline cognitive function at 3 weeks and 5 weeks and 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Derived from this study: PubMed 37620825Zhou Y, Xia X, Zhao X, Yang R, Wu Y, Liu J, Lyu X, Li Z, Zhang G, Du X. Efficacy and safety of Transcranial Direct Current Stimulation (tDCS) on cognitive function in chronic schizophrenia with Tardive Dyskinesia (TD): a randomized, double-blind, sham-controlled, clinical trial. BMC Psychiatry. 2023 Aug 24;23(1):623. doi: 10.1186/s12888-023-05112-0.
- 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.
Guangzhong Yin, MD study chair
Suzhou Guangji Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Tardive Dyskinesia, run by Suzhou Psychiatric Hospital at 2 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal Involuntary Movements Scale (time frame: Change from baseline AIMS(items1-7) total scores at 3 weeks and 5 weeks and 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03497013, which also lists 1 linked publication.
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 24 Aug 2022.