SchizophreniaNCT03602716
High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms of Schizophrenia
A study testing HD-tDCS in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
In this study, investigators designed a double-blind randomized trial to prove a more reliable evidence to show how the treatment by using high-definition transcranial direct current stimulation (HD-tDCS) can relieve negative symptoms in patients with predominant negative symptoms of schizophrenia, especially on… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- HD-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2018to 26 Sep 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with diagnostic schizophrenia by DSM-IV
- patients at an age between 18-60 years of Han nationality
- 1) baseline score equal or higher than 4 in at least two items in negative symptoms at PANSS; 2) or baseline score equal or higher than 3 points in at least 1/3 items (including apathy) for negative symptoms; and 3)No more than 2 items have a score higher than 3 points for positive symptoms at PANSS.
- willing to participate in the experiment and take treatment
Who cannot join
- other psychiatric diagnoses
- criteria for bipolar disorder; dementia; other psychotic disturbs; substance-related disorders
- schizophrenia caused by organic diseases
- other mental disorders caused by drugs and alcohol
- IQ<70
- presence of serious suicidal behaviour
Show all 9Show fewer
- claustrophobic or pregnancy
- metal implantation in vivo
- specific tDCS limitations (such as anatomic problems and high sensitivity on current)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Research on High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms in Patients With Schizophrenia
In this study, investigators designed a double-blind randomized trial to prove a more reliable evidence to show how the treatment by using high-definition transcranial direct current stimulation (HD-tDCS) can relieve negative symptoms in patients with predominant negative symptoms of schizophrenia, especially on improving participants' anhedonia condition and social cognition, through stimulating the left dorsolateral prefrontal cortex (DLPFC). Participants will be divided into active and sham HD-tDCS groups equally.
Read the detailed description
Schizophrenia is one of the most disabling psychiatric disorders that almost 1% worldwide population suffer from this devastating illness. The clinical expression of this illness has been categorized into different dimensions, though most of the patients are well treated with antipsychotic medication, the negative symptom is still one of the very refractory symptoms. Emerging evidence shows that transcranial direct current stimulation (tDCS) is a promising treatment for schizophrenia negative symptoms, however, findings are still controversial. HD-tDCS can provide a more stable and accurate direct current comparing with traditional tDCS, which gives a hope to treat negative symptoms in a more reliable way.
An association between negative symptoms and grey matter reductions in the prefrontal cortex is found, moreover, even during rest, hypoactivity of the prefrontal cortex, particularly of the left dorsolateral, and of the anterior cingulate regions, has been linked to negative symptoms of schizophrenia. It has been observed that tDCS could relatively alleviate negative symptoms in patients with schizophrenia by stimulating the left DLPFC through an anodal electrode, which has been proved can also modulate brain functional connectivity and have clinical improvements.
Half of the participants with a clinical presentation of predominant negative symptoms will be stimulated by active HD-tDCS and the rest will have a sham stimulation. HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at 1 (T2) and 3 (T3) months. A Soterix Medical 4x1 HD-tDCS will be used with the anode placed over the left DLPFC (F3), surrounded by four cathodal electrodes at F5, F1, FC3 and AF3, based on the 10/20 international EEG system. All the outcomes will be assessed at baseline (T0, before HD-tDCS sessions), one day after the 10th HD-tDCS sessions (T1), and also at T2 and T3. Both participants and investigators will be blind to this treatment.
- Conditions
- Schizophrenia
- Being tested
- HD-tDCS, Sham HD-tDCS
- Keywords
- schizophrenia, HD-tDCS, negative symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCSDevice
HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day (+15 s fade-in and fade-out); sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. HD-tDCS will be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system.
Sham HD-tDCSDevice
HD-tDCS is going to be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. This group will have a 20-min-sham stimulation.
| Study group | Role | What they receive |
|---|---|---|
| HD-tDCS group | Experimental | This HD-tDCS group will be stimulated by active HD-tDCS. Receives: Device: HD-tDCS |
| Sham HD-tDCS group | Sham comparator | This sham HD-tDCS group will have a sham stimulation with HD-tDCS. Receives: Device: Sham HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive and Negative Syndrome Scale (PANSS)
a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale.
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
The Scale for the Assessment of Negative Symptoms (SANS)
a 24-items, 5-point rating scale; the 5 rating points represent increasing levels of psychopathology: 0= absent, 1= mild, 2= moderate, 3= severe, 4= extreme; of the 24 items, the first 6 items for Affective Flattening, 5 items for Alogia, 5 items for Avolition, 5 items for Anhedonia, and the remaining 3 items for Attention.
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
The Clinical Assessment Interview for Negative Symptoms (CAINS)
including CAINS and CAINS self-reported checklist
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
Secondary outcomes (8)
the Temporal Experience of Pleasure Scale (TEPS)
a self-reported questionnaire
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Emotional Expression Scale (EES)
a self-reported questionnaire
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Belief About Pleasure Scales (BAPS)
a self-reported questionnaire
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Emotional Regulation Questionnaire (ERQ)
a self-reported questionnaire
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Beck Depression Inventory (BDI)
a self-reported questionnaire
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Effort Expenditure for Rewards Task (EEfRT)
a computer test
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Belief Updating Task
a computer test
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Anticipatory and Consummatory Pleasure (ACP) task performances
a computer test
Measured: Change from baseline through study completion and sustained effects at 1 and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start16 Oct 2018
- Primary completion26 Sep 2020
- Study completion26 Sep 2020
Why it stopped: Study was recruited slowly due to the imapct of some uncontrollable factors, such as COVID19.
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602716
- Sponsor's protocol ID
- 17411970000
- Status last verified
- Dec 2020
- First submitted
- 27 Jun 2018
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research on High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03602716
- Acronym / sponsor ID
- 17411970000
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, HD-tDCS, negative symptoms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was recruited slowly due to the imapct of some uncontrollable factors, such as COVID19.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 26 Sep 2020 (actual)
- First posted
- 27 Jul 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.
In this study, investigators designed a double-blind randomized trial to prove a more reliable evidence to show how the treatment by using high-definition transcranial direct current stimulation (HD-tDCS) can relieve negative symptoms in patients with predominant negative symptoms of schizophrenia, especially on improving participants' anhedonia condition and social cognition, through stimulating the left dorsolateral prefrontal cortex (DLPFC). Participants will be divided into active and sham HD-tDCS groups equally.
Detailed description
Schizophrenia is one of the most disabling psychiatric disorders that almost 1% worldwide population suffer from this devastating illness. The clinical expression of this illness has been categorized into different dimensions, though most of the patients are well treated with antipsychotic medication, the negative symptom is still one of the very refractory symptoms. Emerging evidence shows that transcranial direct current stimulation (tDCS) is a promising treatment for schizophrenia negative symptoms, however, findings are still controversial. HD-tDCS can provide a more stable and accurate direct current comparing with traditional tDCS, which gives a hope to treat negative symptoms in a more reliable way.
An association between negative symptoms and grey matter reductions in the prefrontal cortex is found, moreover, even during rest, hypoactivity of the prefrontal cortex, particularly of the left dorsolateral, and of the anterior cingulate regions, has been linked to negative symptoms of schizophrenia. It has been observed that tDCS could relatively alleviate negative symptoms in patients with schizophrenia by stimulating the left DLPFC through an anodal electrode, which has been proved can also modulate brain functional connectivity and have clinical improvements.
Half of the participants with a clinical presentation of predominant negative symptoms will be stimulated by active HD-tDCS and the rest will have a sham stimulation. HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at 1 (T2) and 3 (T3) months. A Soterix Medical 4x1 HD-tDCS will be used with the anode placed over the left DLPFC (F3), surrounded by four cathodal electrodes at F5, F1, FC3 and AF3, based on the 10/20 international EEG system. All the outcomes will be assessed at baseline (T0, before HD-tDCS sessions), one day after the 10th HD-tDCS sessions (T1), and also at T2 and T3. Both participants and investigators will be blind to this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD-tDCS group | Experimental | Device: HD-tDCSThis HD-tDCS group will be stimulated by active HD-tDCS. |
| Sham HD-tDCS group | Sham comparator | Device: Sham HD-tDCSThis sham HD-tDCS group will have a sham stimulation with HD-tDCS. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with diagnostic schizophrenia by DSM-IV
- patients at an age between 18-60 years of Han nationality
- 1) baseline score equal or higher than 4 in at least two items in negative symptoms at PANSS; 2) or baseline score equal or higher than 3 points in at least 1/3 items (including apathy) for negative symptoms; and 3)No more than 2 items have a score higher than 3 points for positive symptoms at PANSS.
- willing to participate in the experiment and take treatment
Key exclusion criteria (9 listed)
- other psychiatric diagnoses
- criteria for bipolar disorder; dementia; other psychotic disturbs; substance-related disorders
- schizophrenia caused by organic diseases
- other mental disorders caused by drugs and alcohol
- IQ<70
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 |
|---|---|---|
| HD-tDCSHD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day (+15 s fade-in and fade-out); sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. HD-tDCS will be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system. | Device | HD-tDCS group |
| Sham HD-tDCSHD-tDCS is going to be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. This group will have a 20-min-sham stimulation. | Device | Sham HD-tDCS group |
Primary outcome
The Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale.
The Scale for the Assessment of Negative Symptoms (SANS)
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
a 24-items, 5-point rating scale; the 5 rating points represent increasing levels of psychopathology: 0= absent, 1= mild, 2= moderate, 3= severe, 4= extreme; of the 24 items, the first 6 items for Affective Flattening, 5 items for Alogia, 5 items for Avolition, 5 items for Anhedonia, and the remaining 3 items for Attention.
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
including CAINS and CAINS self-reported checklist
8 secondary outcomes
the Temporal Experience of Pleasure Scale (TEPS)
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Emotional Expression Scale (EES)
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Belief About Pleasure Scales (BAPS)
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Emotional Regulation Questionnaire (ERQ)
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Beck Depression Inventory (BDI)
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Effort Expenditure for Rewards Task (EEfRT)
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Belief Updating Task
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
the Anticipatory and Consummatory Pleasure (ACP) task performances
Time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.
Results and safety
The study was stopped early (reason given: Study was recruited slowly due to the imapct of some uncontrollable factors, such as COVID19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 24 Aug 2021. 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 was stopped early (reason given: Study was recruited slowly due to the imapct of some uncontrollable factors, such as COVID19.). Results are not available in the source record.
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 Positive and Negative Syndrome Scale (PANSS) (time frame: Change from baseline through study completion and sustained effects at 1 and 3 months.). The study lists 3 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 24 Aug 2021.