SchizophreniaNCT04086160
Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset
A study testing Transcranial direct current stimulation device (Soterix Medical, New York, NY) in people with Schizophrenia and Psychosis, run by Dr WANG Shumei at 1 site in Hong Kong.
Trial summary
The purposes of this research are to investigate (1) if schizophrenia patients and at-risk individuals present bradykinesia and dyskinesia and (2) if tDCS improves motor performance in schizophrenia patients and at-risk individuals. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychosis, Parkinsonism
- What is being tested?
- Transcranial direct current stimulation device (Soterix Medical, New York, NY)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Aug 2019to 31 Dec 2023
- 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 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- a diagnosis of schizophrenia without other psychiatric diseases
- having stable psychotic symptoms
- a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
- having no neurological diseases and no medical conditions that affect motor performance
- No Exclusion Criteria.
- a score of nine or above in the Chinese version of the 16-item Prodromal Questionnaire (CPQ-16)
Show all 15Show fewer
- a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
- having no diagnosis of psychiatric diseases
- having no neurological diseases and no medical conditions that affect motor performance
- No Exclusion Criteria.
- a score less than nine in CPQ-16
- a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
- having no diagnosis of psychiatric diseases
- having no neurological diseases and no medical conditions that affect motor performance.
- No Exclusion Criteria.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Polytechnic University
Kowloon
Shu-Mei Wang, PhD, 852-27664197, shumei.wang@polyu.edu.hk
About this study
The purposes of this research are to investigate (1) if schizophrenia patients and at-risk individuals present bradykinesia and dyskinesia and (2) if tDCS improves motor performance in schizophrenia patients and at-risk individuals. The first hypothesis is that both schizophrenia patients and at-risk individuals show bradykinesia and dyskinesia, and the motor symptoms are more severe in the former than the latter. The second hypothesis is that tDCS improves motor performance in schizophrenia patients and at-risk cases.
- Conditions
- Schizophrenia, Psychosis, Parkinsonism, Dyskinesias
- Being tested
- Transcranial direct current stimulation device (Soterix Medical, New York, NY)
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Parkinsonian Disorders, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation device (Soterix Medical, New York, NY)Device
Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia- tDCS | Experimental | Not described Receives: Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| schizophrenia- sham | Sham comparator | Not described Receives: Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| at risk- tDCS | Experimental | Not described Receives: Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| at risk- sham | Sham comparator | Not described Receives: Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| healthy controls for schizophrenia- tDCS | Experimental | Not described Receives: Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| healthy controls for schizophrenia- sham | Sham comparator | Not described Receives: Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| healthy controls for at risk- tDCS | Experimental | Not described Receives: Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| healthy controls for at risk- sham | Sham comparator | Not described Receives: Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Measured: Within one week right before the 1st session of tDCS
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Measured: Within one week right after the 8th (last) session of tDCS
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Measured: Within one week right before the 1st session of tDCS
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Measured: Within one week right after the 8th (last) session of tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start22 Aug 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr WANG Shumei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr WANG Shumei, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086160
- Sponsor's protocol ID
- HSEARS20190518001
- Status last verified
- Feb 2023
- First submitted
- 27 Jul 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset
- ClinicalTrials.gov ID
- NCT04086160
- Acronym / sponsor ID
- HSEARS20190518001
- Conditions
- Schizophrenia, Psychosis, Parkinsonism, Dyskinesias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr WANG ShumeiUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Sep 2019 (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 purposes of this research are to investigate (1) if schizophrenia patients and at-risk individuals present bradykinesia and dyskinesia and (2) if tDCS improves motor performance in schizophrenia patients and at-risk individuals. The first hypothesis is that both schizophrenia patients and at-risk individuals show bradykinesia and dyskinesia, and the motor symptoms are more severe in the former than the latter. The second hypothesis is that tDCS improves motor performance in schizophrenia patients and at-risk cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| schizophrenia- tDCS | Experimental | Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| schizophrenia- sham | Sham comparator | Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| at risk- tDCS | Experimental | Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| at risk- sham | Sham comparator | Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| healthy controls for schizophrenia- tDCS | Experimental | Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| healthy controls for schizophrenia- sham | Sham comparator | Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| healthy controls for at risk- tDCS | Experimental | Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
| healthy controls for at risk- sham | Sham comparator | Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- a diagnosis of schizophrenia without other psychiatric diseases
- having stable psychotic symptoms
- a score of 22 or above in Hong Kong version Montreal Cognitive Assessment
- having no neurological diseases and no medical conditions that affect motor performance
- No Exclusion Criteria.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Transcranial direct current stimulation device (Soterix Medical, New York, NY)Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session. | Device | at risk- sham, at risk- tDCS, healthy controls for at risk- sham, healthy controls for at risk- tDCS, healthy controls for schizophrenia- sham, healthy controls for schizophrenia- tDCS, schizophrenia- sham, schizophrenia- tDCS |
Primary outcome
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Time frame: Within one week right before the 1st session of tDCS
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Time frame: Within one week right after the 8th (last) session of tDCS
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Time frame: Within one week right before the 1st session of tDCS
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Time frame: Within one week right after the 8th (last) session of tDCS
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- 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 Transcranial direct current stimulation device (Soterix Medical, New York, NY) in people with Schizophrenia and Psychosis, run by Dr WANG Shumei at 1 site in Hong Kong.
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 15 inclusion and 0 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 1 Mar 2023. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Mei Wang, PhD (852-27664197, shumei.wang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) (time frame: Within one week right before the 1st session of tDCS). The study lists 4 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 1 Mar 2023.