SchizophreniaNCT04859504
Developing Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia
A study testing transcranial alternating current stimulation (NE Starstim) in people with Schizophrenia and Transcranial Alternating Current Stimulations, run by Shanghai Mental Health Center at 2 sites in China.
Trial summary
Negative symptoms are core symptoms in schizophrenia which play an important role in clinical outcomes and impede patients to return to society. Anti-psychotic medicines have shown limited effect in improving negative symptoms and cognitive functioning, whereas non-invasive neuromodulations, i.e. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Transcranial Alternating Current Stimulations, Negative Symptoms
- What is being tested?
- transcranial alternating current stimulation (NE Starstim)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2021to 31 Jul 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- meet the DSM-V diagnostic criteria for schizophrenia;
- present with prominent negative symptoms with PANSS-negative scores >20, at least one score of PANSS N1-N7 >3, and reductive ratio of PANSS-negative in the past two weeks before recruitment <10%;
- stable usage and dosage of anti-psychotic medicines in the past two weeks and during the tACS intervention.
- age within 18-60;
- illness duration >1year;
- education at least 6 years;
- written consent of receiving tACS intervention.
Who cannot join
- Meet any DSM-V diagnostic criteria of any other psychiatric disorders besides schizophrenia ;
- any history of alcohol or substance dependence in the past 3 months;
- any other major physical disease (i.e., Sensorimotor disorder, neurological disease);
- any metal implants or any other tACS contraindication.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Zhengjiang Mental Health Center
Zhenjiang, Jiangsu
About this study
Official title: Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia Patients: a Randomized Clinical Trial
Negative symptoms are core symptoms in schizophrenia which play an important role in clinical outcomes and impede patients to return to society. Anti-psychotic medicines have shown limited effect in improving negative symptoms and cognitive functioning, whereas non-invasive neuromodulations, i.e. , transcranial alternating current stimulation (tACS), have shown promising potentials. Recently new evidence of brain structural and functional alterations has been provided by neuroimaging studies. Brady RO et al. found cerebellar-prefrontal network connectivity was related to negative symptoms in schizophrenia. It provides clues for developing a new tACS protocol targeting improving negative symptoms, in which dual-channel high-density alternating current stimulations were delivered over both the right dorsolateral prefrontal cortex and cerebellum simultaneously.
- Being tested
- transcranial alternating current stimulation (NE Starstim)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial alternating current stimulation (NE Starstim)Device
dual-channel theta-tACS over right DLPFC and cerebellum simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Active tACS | Active comparator | Active tACS will be applied twice daily for 5 days. In each session, dual-channel high-density theta(7Hz) tACS stimulations will be delivered over the right DLPFC (one anodal electrode at F4, between -1.2mA and 1.2 mA; two cathodal electrodes at AF4 and FC6, between -0.6mA and 0.6mA) and cerebellum (one anodal electrode at Oz, between -1 mA and 1mA; two cathodal electrodes at PO3 and PO4, between -0.5mA and 0.5mA) lasting 20 minutes. Receives: Device: transcranial alternating current stimulation (NE Starstim) |
| Sham tACS | Sham comparator | Sham tACS will be also applied twice daily for 5 days.The parameters of tACS electrodes numbers, locations, and current duration are all the same with active tACS. But sham tACS begin with a fade in over 3s to the peak, followed immediately by no current stimulation for 20 minutes and a fade out of 3s. Receives: Device: transcranial alternating current stimulation (NE Starstim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
reductive ratio of PANSS-negative symptoms scores
differences of reductive ratio of PANSS-negative symptoms scores after between active and sham tACS
Measured: At 1 week and 3 weeks
Secondary outcomes (7)
changes of PANSS total scores
changes of PANSS total scores before and after active or sham tACS
Measured: At 1 week and 3 weeks
cognitive functioning changes using MCCB
changes of MCCB scores before and after active or sham tACS
Measured: At 1 week and 3 weeks
changes of P300 activity
changes of P300 activity at baseline and after 10-session tACS
Measured: At 1 week
changes of MMN activity
changes of MMN activity at baseline and after 10-session tACS
Measured: At 1 week
changes of power of resting-state EEG activity
changes of power of resting-state EEG activity at baseline, after 1-session tACS and after 10-session tACS
Measured: At 1 day and 1 week
centroid value from fNIRS recording before and after active or sham tACS
centroid value from fNIRS recording before and after active or sham tACS
Measured: At 1 week
Integral value from fNIRS recording before and after active or sham tACS
Intergral value from fNIRS recording before and after active or sham tACS
Measured: At 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingying Tang, PhD, Principal investigator, Shanghai Mental Health CenterJianhua Sheng, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859504
- Sponsor's protocol ID
- 20191836
- Status last verified
- Jul 2024
- First submitted
- 1 Apr 2021
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will decide IPD or not when the clinical trial is completed.
Publications
Brady RO Jr, Gonsalvez I, Lee I, Ongur D, Seidman LJ, Schmahmann JD, Eack SM, Keshavan MS, Pascual-Leone A, Halko MA. Cerebellar-Prefrontal Network Connectivity and Negative Symptoms in Schizophrenia. Am J Psychiatry. 2019 Jul 1;176(7):512-520. doi: 10.1176/appi.ajp.2018.18040429. Epub 2019 Jan 30.
PubMed 30696271Reinhart RMG, Nguyen JA. Working memory revived in older adults by synchronizing rhythmic brain circuits. Nat Neurosci. 2019 May;22(5):820-827. doi: 10.1038/s41593-019-0371-x. Epub 2019 Apr 8.
PubMed 30962628Smith RC, Md WL, Wang Y, Jiang J, Wang J, Szabo V, Faull R, Jin H, Davis JM, Li C. Effects of transcranial direct current stimulation on cognition and symptoms in Chinese patients with schizophrenia✰. Psychiatry Res. 2020 Feb;284:112617. doi: 10.1016/j.psychres.2019.112617. Epub 2019 Nov 2.
PubMed 31806403
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-channel Transcranial Alternating Current Stimulations Targeting Negative Symptoms in Schizophrenia Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04859504
- Acronym / sponsor ID
- 20191836
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 26 Apr 2021 (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.
Negative symptoms are core symptoms in schizophrenia which play an important role in clinical outcomes and impede patients to return to society. Anti-psychotic medicines have shown limited effect in improving negative symptoms and cognitive functioning, whereas non-invasive neuromodulations, i.e. , transcranial alternating current stimulation (tACS), have shown promising potentials. Recently new evidence of brain structural and functional alterations has been provided by neuroimaging studies. Brady RO et al. found cerebellar-prefrontal network connectivity was related to negative symptoms in schizophrenia. It provides clues for developing a new tACS protocol targeting improving negative symptoms, in which dual-channel high-density alternating current stimulations were delivered over both the right dorsolateral prefrontal cortex and cerebellum simultaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tACS | Active comparator | Device: transcranial alternating current stimulation (NE Starstim)Active tACS will be applied twice daily for 5 days. In each session, dual-channel high-density theta(7Hz) tACS stimulations will be delivered over the right DLPFC (one anodal electrode at F4, between -1.2mA and 1.2 mA; two cathodal electrodes at AF4 and FC6, between -0.6mA and 0.6mA) and cerebellum (one anodal electrode at Oz, between -1 mA and 1mA; two cathodal electrodes at PO3 and PO4, between -0.5mA and 0.5mA) lasting 20 minutes. |
| Sham tACS | Sham comparator | Device: transcranial alternating current stimulation (NE Starstim)Sham tACS will be also applied twice daily for 5 days.The parameters of tACS electrodes numbers, locations, and current duration are all the same with active tACS. But sham tACS begin with a fade in over 3s to the peak, followed immediately by no current stimulation for 20 minutes and a fade out of 3s. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- meet the DSM-V diagnostic criteria for schizophrenia;
- present with prominent negative symptoms with PANSS-negative scores >20, at least one score of PANSS N1-N7 >3, and reductive ratio of PANSS-negative in the past two weeks before recruitment <10%;
- stable usage and dosage of anti-psychotic medicines in the past two weeks and during the tACS intervention.
- age within 18-60;
- illness duration >1year;
Key exclusion criteria (4 listed)
- Meet any DSM-V diagnostic criteria of any other psychiatric disorders besides schizophrenia ;
- any history of alcohol or substance dependence in the past 3 months;
- any other major physical disease (i.e., Sensorimotor disorder, neurological disease);
- any metal implants or any other tACS contraindication.
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 alternating current stimulation (NE Starstim)dual-channel theta-tACS over right DLPFC and cerebellum simultaneously | Device | Active tACS, Sham tACS |
Primary outcome
reductive ratio of PANSS-negative symptoms scores
Time frame: At 1 week and 3 weeks
differences of reductive ratio of PANSS-negative symptoms scores after between active and sham tACS
7 secondary outcomes
changes of PANSS total scores
Time frame: At 1 week and 3 weeks
cognitive functioning changes using MCCB
Time frame: At 1 week and 3 weeks
changes of P300 activity
Time frame: At 1 week
changes of MMN activity
Time frame: At 1 week
changes of power of resting-state EEG activity
Time frame: At 1 day and 1 week
centroid value from fNIRS recording before and after active or sham tACS
Time frame: At 1 week
Integral value from fNIRS recording before and after active or sham tACS
Time frame: At 1 week
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 12 Dec 2024.
- Background: PubMed 30696271Brady RO Jr, Gonsalvez I, Lee I, Ongur D, Seidman LJ, Schmahmann JD, Eack SM, Keshavan MS, Pascual-Leone A, Halko MA. Cerebellar-Prefrontal Network Connectivity and Negative Symptoms in Schizophrenia. Am J Psychiatry. 2019 Jul 1;176(7):512-520. doi: 10.1176/appi.ajp.2018.18040429. Epub 2019 Jan 30.
- Background: PubMed 30962628Reinhart RMG, Nguyen JA. Working memory revived in older adults by synchronizing rhythmic brain circuits. Nat Neurosci. 2019 May;22(5):820-827. doi: 10.1038/s41593-019-0371-x. Epub 2019 Apr 8.
- Background: PubMed 31806403Smith RC, Md WL, Wang Y, Jiang J, Wang J, Szabo V, Faull R, Jin H, Davis JM, Li C. Effects of transcranial direct current stimulation on cognition and symptoms in Chinese patients with schizophrenia✰. Psychiatry Res. 2020 Feb;284:112617. doi: 10.1016/j.psychres.2019.112617. Epub 2019 Nov 2.
- Individual participant dataSharing planned: Undecided. We will decide IPD or not when the clinical trial is completed.
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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.
Yingying Tang, PhD principal investigator
Shanghai Mental Health Center
Jianhua Sheng, PhD principal investigator
Shanghai Mental Health Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial alternating current stimulation (NE Starstim) in people with Schizophrenia and Transcranial Alternating Current Stimulations, run by Shanghai Mental Health Center 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 7 inclusion and 4 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 12 Dec 2024. 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?
reductive ratio of PANSS-negative symptoms scores (time frame: At 1 week and 3 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 NCT04859504, which also lists 3 linked publications.
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 12 Dec 2024.