Precise Intervention Technology and Application of Low Intensity TUS on Negative Symptoms of Schizophrenia
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ClinicalTrials.gov Identifier: NCT05985993 |
Recruitment Status :
Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : August 14, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Negative Symptoms of Schizophrenia | Device: low-intensity transcranial ultrasound stimulation (TUS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Precise Intervention Technology and Application of Low Intensity Transcranial Ultrasound Stimulation (TUS) on Negative Symptoms of Schizophrenia |
Estimated Study Start Date : | September 1, 2023 |
Estimated Primary Completion Date : | July 31, 2025 |
Estimated Study Completion Date : | December 31, 2025 |
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Arm | Intervention/treatment |
---|---|
Active Comparator: single-target group (left DLPFC)
34 eligible patients will be treated with active TUS for 4 weeks on the left DLPFC
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Device: low-intensity transcranial ultrasound stimulation (TUS)
The rTUS was administered using an immersion-type focused ultrasound transducer (V391-SU, Olympus NDT, Waltham, USA). Low-intensity transcranial ultrasound stimulation on the target. Duration:20 days (workdays for four consecutive weeks). |
Active Comparator: both-target group (both left DLPFC and right STG)
34 eligible patients will be treated with active TUS for 4 weeks on the both left DLPFC and right STG
|
Device: low-intensity transcranial ultrasound stimulation (TUS)
The rTUS was administered using an immersion-type focused ultrasound transducer (V391-SU, Olympus NDT, Waltham, USA). Low-intensity transcranial ultrasound stimulation on the target. Duration:20 days (workdays for four consecutive weeks). |
Sham Comparator: sham group
34 eligible patients will be treated with sham TUS for 4 weeks on the left DLPFC
|
Device: low-intensity transcranial ultrasound stimulation (TUS)
The rTUS was administered using an immersion-type focused ultrasound transducer (V391-SU, Olympus NDT, Waltham, USA). Low-intensity transcranial ultrasound stimulation on the target. Duration:20 days (workdays for four consecutive weeks). |
- Change from baseline in the Scale for Assessment of Negative Symptoms(SANS) [ Time Frame: baseline, 4 weeks and 8 weeks ]Change from baseline in the Scale for Assessment of Negative Symptoms(SANS) at 4 weeks and 8 weeks. The minimum to maximum value is 0-120. Lower scores mean a better outcome.
- Change from baseline in Positive and Negative Syndrome Scale(PANSS) [ Time Frame: baseline, 4 weeks and 8 weeks ]Change from baseline in Positive and Negative Syndrome Scale(PANSS) at 4 weeks and 8 weeks. The minimum to maximum value is 30-210. Lower scores mean a better outcome.
- Cognitive Function [ Time Frame: baseline, 4 weeks and 8 weeks ]Change from baseline in MATRICS MCCB
- Change of Multi-modal Brain Neuroimaging in structure [ Time Frame: baseline and 4 weeks ]Brain structure data will be acquired.
- Change of Multi-modal Brain Neuroimaging in resting- state fMRI [ Time Frame: baseline and 4 weeks ]Resting-state fMRI data will be acquired.
- Change of Multi-modal Brain Neuroimaging in 1H-MRS [ Time Frame: baseline and 4 weeks ]1H-MRS data will be acquired.
- Change of functional near-infrared spectroscopy (fNIRS) [ Time Frame: baseline ]Functional near-infrared spectroscopy (fNIRS), a non-invasive neuroimaging technique that reflects changes in Oxy-Hb and Deoxy-Hb during brain activity, will be measured on left M1 region at baseline to evaluate the neuromodulation effect of TUS on neural activity.
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meet the DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder;
- Age18-50, right-handed, Han nationality;
- Score of at least 1 item from N1 to N7 in PANSS is ≥4 (moderate or above);
- Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more;
- Written informed consent;
Exclusion Criteria:
- 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.;
- History of MECT or other physical therapy within 6 months;
- 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 TUS and MRI are present.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05985993
Contact: Dengtang LIU | 021-34773434 | erliu110@126.com |
China, Shanghai | |
Shanghai Mental Health Center | |
Shanghai, Shanghai, China, 200030 | |
Contact: Dengtang LIU 021-34773434 erliu110@126.com |
Responsible Party: | Dengtang LIU, Chief Psychiatrist and Professor, Shanghai Mental Health Center |
ClinicalTrials.gov Identifier: | NCT05985993 |
Other Study ID Numbers: |
2022JC009 |
First Posted: | August 14, 2023 Key Record Dates |
Last Update Posted: | August 14, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Schizophrenia Negative Symptoms Transcranial Ultrasound Stimulation |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |