Negative Symptoms of SchizophreniaNCT04620460
Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia
A study testing Low-intensity Focused Ultrasound(LIFUS) in people with Negative Symptoms of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Based on our research background, we hypothesize that LIFUS has neuromodulation effects on brain cortex and the active LIFUS on left-DLPFC would improve negative symptoms in schizophrenia patients. It would firstly verify the safety of LIFUS on human as well. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Negative Symptoms of Schizophrenia
- What is being tested?
- Low-intensity Focused Ultrasound(LIFUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2020to 31 Jul 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meet the DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder;
- Age18-50, right-handed, Han nationality;
- the score of at least 1 item from N1 to N7 is ≥4 (moderate or above);
- Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more;
- Written informed consent;
Who cannot join
- Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnant or lactation;
- Uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.;
- A history of MECT or other physical therapy within 6 months;
- A history of epilepsy, or epileptic waves on the baseline EEG;
- Ruled out share antiepileptic drugs, carbamazepine, valproic acid salt) or larger doses of benzodiazepines drugs (> 10 mg/day, diazepam clonazepam 2 mg/day, 1 mg/day, alprazolam lorazepam 2 mg/day, midazolam 10 mg/day, 20 mg/day, Mr Shah diazepam triazolam 0.5 mg/day), avoid the use of chlorine drug, (in principle, to avoid the use of antiepileptic drugs and clonazepam;Other antipsychotic drugs, if necessary, remain unchanged during the course of treatment;
- Contraindications to LIFUS and MRI are present.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Dengtang LIU, 18017311138, erliu110@126.com
About this study
Based on our research background, we hypothesize that LIFUS has neuromodulation effects on brain cortex and the active LIFUS on left-DLPFC would improve negative symptoms in schizophrenia patients. It would firstly verify the safety of LIFUS on human as well. The multimodal MRI will be contributed to investigate the possible mechanism of negative symptoms.
Read the detailed description
Firstly, we plan to explore the short-term effects of LIFUS on cortical excitability by detecting the MEP amplitude. 40 patients and relatively well matched healthy-control would be enrolled. After MEP detection and baseline evaluations, the two groups will be treated with one-single intervention on the primary motor cortex. The cognitive function and MEP amplitude will be assessed respectively at the moment, after 15 minutes and 30 minutes. Then, it is a randomized double-blind sham-controlled LIFUS intervention trial in schizophrenia patients. After screening and baseline evaluations, the 40 patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC. The multimodal MRI will be acquired. Clinical symptoms and cognitive function will be assessed respectively at baseline, at the end of fifth treatments and after the end of the treatment.
- Conditions
- Negative Symptoms of Schizophrenia
- Being tested
- Low-intensity Focused Ultrasound(LIFUS)
- Keywords
- Low-intensity Focused Ultrasound, Negative Symptoms of Schizophrenia Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity Focused Ultrasound(LIFUS)Device
Patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC.
| Study group | Role | What they receive |
|---|---|---|
| LIFUS-left DLPFC | Active comparator | 20 patients will be treated with active LIFUS for 3 weeks on the left DLPFC. Receives: Device: Low-intensity Focused Ultrasound(LIFUS) |
| LIFUS-SHAM | Sham comparator | 20 patients will be treated with sham LIFUS for 3 weeks on the left DLPFC. Receives: Device: Low-intensity Focused Ultrasound(LIFUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Symptoms-PANSS
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Measured: baseline and 15 days
Clinical Symptoms-SANS
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)
Measured: baseline and 15 days
Secondary outcomes (3)
Cognitive Function
Change from baseline in the Brief Cognition Test (C-BCT)
Measured: baseline, after the fifth treatment and 15 days
Change of brain neuroimaging
Brain structure, Resting-state fMRI data, Arterial Spin Labeling(ASL), 1H-MRS in DLPFC are acquired.
Measured: baseline, fifth treatment and 15th treatment
Cortex Excitability
MEP amplitude
Measured: baseline，the moment after the intervention, after 15 minutes and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start5 Aug 2020
- Primary completionJul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
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 Negative Symptoms of 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, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dengtang LIU, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620460
- Sponsor's protocol ID
- 2020-TX-006
- Status last verified
- Aug 2021
- First submitted
- 15 Oct 2020
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhai Z, Ren L, Song Z, Xiang Q, Zhuo K, Zhang S, Li X, Zhang Y, Jiao X, Tong S, Sun J, Liu D. The efficacy of low-intensity transcranial ultrasound stimulation on negative symptoms in schizophrenia: A double-blind, randomized sham-controlled study. Brain Stimul. 2023 May-Jun;16(3):790-792. doi: 10.1016/j.brs.2023.04.021. Epub 2023 Apr 29. No abstract available.
PubMed 37121354
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT04620460
- Acronym / sponsor ID
- 2020-TX-006
- Conditions
- Negative Symptoms of Schizophrenia
- Keywords
- Low-intensity Focused Ultrasound, Negative Symptoms of Schizophrenia Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 9 Nov 2020 (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.
Based on our research background, we hypothesize that LIFUS has neuromodulation effects on brain cortex and the active LIFUS on left-DLPFC would improve negative symptoms in schizophrenia patients. It would firstly verify the safety of LIFUS on human as well. The multimodal MRI will be contributed to investigate the possible mechanism of negative symptoms.
Detailed description
Firstly, we plan to explore the short-term effects of LIFUS on cortical excitability by detecting the MEP amplitude. 40 patients and relatively well matched healthy-control would be enrolled. After MEP detection and baseline evaluations, the two groups will be treated with one-single intervention on the primary motor cortex. The cognitive function and MEP amplitude will be assessed respectively at the moment, after 15 minutes and 30 minutes. Then, it is a randomized double-blind sham-controlled LIFUS intervention trial in schizophrenia patients. After screening and baseline evaluations, the 40 patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC. The multimodal MRI will be acquired. Clinical symptoms and cognitive function will be assessed respectively at baseline, at the end of fifth treatments and after the end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIFUS-left DLPFC | Active comparator | Device: Low-intensity Focused Ultrasound(LIFUS)20 patients will be treated with active LIFUS for 3 weeks on the left DLPFC. |
| LIFUS-SHAM | Sham comparator | Device: Low-intensity Focused Ultrasound(LIFUS)20 patients will be treated with sham LIFUS for 3 weeks on the left DLPFC. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (6 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 |
|---|---|---|
| Low-intensity Focused Ultrasound(LIFUS)Patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC. | Device | LIFUS-SHAM, LIFUS-left DLPFC |
Primary outcome
Clinical Symptoms-PANSS
Time frame: baseline and 15 days
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
Clinical Symptoms-SANS
Time frame: baseline and 15 days
Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)
3 secondary outcomes
Cognitive Function
Time frame: baseline, after the fifth treatment and 15 days
Change of brain neuroimaging
Time frame: baseline, fifth treatment and 15th treatment
Cortex Excitability
Time frame: baseline，the moment after the intervention, after 15 minutes and 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Derived from this study: PubMed 37121354Zhai Z, Ren L, Song Z, Xiang Q, Zhuo K, Zhang S, Li X, Zhang Y, Jiao X, Tong S, Sun J, Liu D. The efficacy of low-intensity transcranial ultrasound stimulation on negative symptoms in schizophrenia: A double-blind, randomized sham-controlled study. Brain Stimul. 2023 May-Jun;16(3):790-792. doi: 10.1016/j.brs.2023.04.021. Epub 2023 Apr 29. No abstract available.
- 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 Low-intensity Focused Ultrasound(LIFUS) in people with Negative Symptoms of 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 5 inclusion and 6 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 19 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dengtang LIU (18017311138 ext. 86, erliu110@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Symptoms-PANSS (time frame: baseline and 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 NCT04620460, 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 19 Aug 2021.