SchizophreniaNCT02748083
Transcranial Direct Current Stimulation (tDCS) as a Treatment for Cognitive Deficits in Schizophrenic
A study testing tDCS in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This trial attempts to evaluate the effects of intensive transcranial direct-current stimulation (tDCS) on improving cognition in schizophrenia patients and changes in resting state brain network connectivity, especially increasing connectivity in the tasks related network, and increasing activation the DLPFC in a… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2015to 1 Oct 2017
- 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
- Subjects who have cognitive deficits as indicated by a score of < 85 on RBANS, and meet criteria for DSM-5 diagnosis of chronic SZ, schizoaffective disorder (SA), or schizophreniform disorder (SZF), and who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms.
Who cannot join
- Patients with risk factors for an MRI scan, seizure disorder, and for women of childbearing age who are pregnant or regularly engaging in sexual activity and not regularly using an acceptable birth control method (systemic or double-barrier).
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Research on Transcranial Direct Current Stimulation (tDCS) as a Treatment for Cognitive Deficits in Schizophrenic
This trial attempts to evaluate the effects of intensive transcranial direct-current stimulation (tDCS) on improving cognition in schizophrenia patients and changes in resting state brain network connectivity, especially increasing connectivity in the tasks related network, and increasing activation the DLPFC in a working memory task. Half of the participants will be randomized to tDCS group, while the other half will be randomized to receive sham tDCS.
Read the detailed description
Schizophrenia patients (SZ) show profound and persistent cognitive deficits in attention, executive processing, and verbal and visuospatial memory, which persist even after psychotic symptoms are ameliorated. Cognitive deficits may be more important in preventing functional, occupational, and social recovery in SZ than other symptom domains and are not effectively treated by current pharmacological approaches. Transcranial direct-current stimulation (tDCS) is less expensive than other modalities (e.g. repetitive transcranial magnetic stimulation; rTMS), easily available, and has a good safety profile in healthy controls (HC) and SZ. However, these prior studies did not make use of a validated measure such as the MATRICS consensus battery (MCCB), which is now established as the standard for assessing cognitive improvement in SZ. Despite these promising preliminary results, this effect of tDCS in SZ needs to be confirmed and the underlying biological mechanism elucidated. Therefore, the investigators employed MCCB to evaluate the effects on improving cognition and functional MRI to explore the underlying mechanism.
Half of the participants will be randomized to tDCS group, while the other half will be randomized to receive sham tDCS. Active vs. sham treatment will be randomly using computer generated lists. Subjects and researcher-administrators of tDCS and testers or evaluators will be blind to treatment.The main cognitive outcome measure, the MCCB, will be administered at baseline and 1 day after the last tDCS session.Participants will be scanned once prior to tDCS sessions, and within one day after the 10th tDCS sessions using our Siemens 3T Verio MRI scanner.
- Conditions
- Schizophrenia
- Being tested
- tDCS, Sham tDCS
- Keywords
- tDCS, schizophrenia, cognition, fMRI
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Electrodes for tDCS will have the anode placed over the left DLPFC (F3) and the cathode over the contralateral (right) supraorbital ridge. The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tDCS sessions on consecutive days (weekends and holidays excluded). The tDCS group will have 10 active or sham tDCS sessions. The active group will be stimulated with a 2 mA current for 20 minutes.
Sham tDCSDevice
Electrodes for tDCS will have the anode placed over the left DLPFC (F3) and the cathode over the contralateral (right) supraorbital ridge. The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tDCS sessions on consecutive days (weekends and holidays excluded). The sham tDCS group will have 10 active or sham tDCS sessions. The sham group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min.
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Active comparator | The active tDCS group will be stimulated with transcranial Direct Current Stimulation (tDCS). Receives: Device: tDCS |
| Sham tDCS group | Sham comparator | The sham tDCS group will have stimulation with sham transcranial Direct Current Stimulation (tDCS). Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MATRICS Consensus Cognitive Battery (MCCB)
Measured: Change from Baseline MCCB through study completion, an average of 15 days
Neuroimage changes in Magnetic Resonance Imaging (MRI)
Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)
Measured: Change from Baseline MCCB through study completion, an average of 15 days
Secondary outcomes (3)
The CogState: Working memory and attention
Measured: through study completion, an average of 15 days
The Positive and Negative Syndrome Scale (PANSS)
Measured: Change from Baseline MCCB through study completion, an average of 15 days
Side-effects of tDCS
Measured: through study completion, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start1 Dec 2015
- Primary completion1 Sep 2017
- Study completion1 Oct 2017
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 SchizophreniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research
- Responsible party
- Sponsor
- Investigators
- Chunbo Li, Ph.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748083
- Sponsor's protocol ID
- 2015-09
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2016
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share IPD data
Publications
Smith 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 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Transcranial Direct Current Stimulation (tDCS) as a Treatment for Cognitive Deficits in Schizophrenic
- ClinicalTrials.gov ID
- NCT02748083
- Acronym / sponsor ID
- 2015-09
- Conditions
- Schizophrenia
- Keywords
- tDCS, schizophrenia, cognition, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 22 Apr 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.
This trial attempts to evaluate the effects of intensive transcranial direct-current stimulation (tDCS) on improving cognition in schizophrenia patients and changes in resting state brain network connectivity, especially increasing connectivity in the tasks related network, and increasing activation the DLPFC in a working memory task. Half of the participants will be randomized to tDCS group, while the other half will be randomized to receive sham tDCS.
Detailed description
Schizophrenia patients (SZ) show profound and persistent cognitive deficits in attention, executive processing, and verbal and visuospatial memory, which persist even after psychotic symptoms are ameliorated. Cognitive deficits may be more important in preventing functional, occupational, and social recovery in SZ than other symptom domains and are not effectively treated by current pharmacological approaches. Transcranial direct-current stimulation (tDCS) is less expensive than other modalities (e.g. repetitive transcranial magnetic stimulation; rTMS), easily available, and has a good safety profile in healthy controls (HC) and SZ. However, these prior studies did not make use of a validated measure such as the MATRICS consensus battery (MCCB), which is now established as the standard for assessing cognitive improvement in SZ. Despite these promising preliminary results, this effect of tDCS in SZ needs to be confirmed and the underlying biological mechanism elucidated. Therefore, the investigators employed MCCB to evaluate the effects on improving cognition and functional MRI to explore the underlying mechanism.
Half of the participants will be randomized to tDCS group, while the other half will be randomized to receive sham tDCS. Active vs. sham treatment will be randomly using computer generated lists. Subjects and researcher-administrators of tDCS and testers or evaluators will be blind to treatment.The main cognitive outcome measure, the MCCB, will be administered at baseline and 1 day after the last tDCS session.Participants will be scanned once prior to tDCS sessions, and within one day after the 10th tDCS sessions using our Siemens 3T Verio MRI scanner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Active comparator | Device: tDCSThe active tDCS group will be stimulated with transcranial Direct Current Stimulation (tDCS). |
| Sham tDCS group | Sham comparator | Device: Sham tDCSThe sham tDCS group will have stimulation with sham transcranial Direct Current Stimulation (tDCS). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects who have cognitive deficits as indicated by a score of < 85 on RBANS, and meet criteria for DSM-5 diagnosis of chronic SZ, schizoaffective disorder (SA), or schizophreniform disorder (SZF), and who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms.
Key exclusion criteria (1 listed)
- Patients with risk factors for an MRI scan, seizure disorder, and for women of childbearing age who are pregnant or regularly engaging in sexual activity and not regularly using an acceptable birth control method (systemic or double-barrier).
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 |
|---|---|---|
| tDCSElectrodes for tDCS will have the anode placed over the left DLPFC (F3) and the cathode over the contralateral (right) supraorbital ridge. The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tDCS sessions on consecutive days (weekends and holidays excluded). The tDCS group will have 10 active or sham tDCS sessions. The active group will be stimulated with a 2 mA current for 20 minutes. | Device | tDCS group |
| Sham tDCSElectrodes for tDCS will have the anode placed over the left DLPFC (F3) and the cathode over the contralateral (right) supraorbital ridge. The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tDCS sessions on consecutive days (weekends and holidays excluded). The sham tDCS group will have 10 active or sham tDCS sessions. The sham group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min. | Device | Sham tDCS group |
Primary outcome
The MATRICS Consensus Cognitive Battery (MCCB)
Time frame: Change from Baseline MCCB through study completion, an average of 15 days
Neuroimage changes in Magnetic Resonance Imaging (MRI)
Time frame: Change from Baseline MCCB through study completion, an average of 15 days
Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)
3 secondary outcomes
The CogState: Working memory and attention
Time frame: through study completion, an average of 15 days
The Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from Baseline MCCB through study completion, an average of 15 days
Side-effects of tDCS
Time frame: through study completion, an average of 15 days
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 17 Jan 2019.
- Derived from this study: 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: No. No plan to share IPD data
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Schizophrenia
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
RecruitingObservational study
Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
Schizophrenia
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia
Schizophrenia
Not yet recruitingPhase 1
Phase I Trial of HHK101 in Patients With Schizophrenia
Schizophrenia
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.
Chunbo Li, Ph.D. principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Schizophrenia, 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 1 inclusion and 1 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 17 Jan 2019. 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. 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?
The MATRICS Consensus Cognitive Battery (MCCB) (time frame: Change from Baseline MCCB through study completion, an average of 15 days). 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?
On the ClinicalTrials.gov record for NCT02748083, 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 17 Jan 2019.