Precise Intervention Technology and Application of Low Intensity TUS on Negative Symptoms of Schizophrenia

NCT05985993 | Recruiting

• 1 other identifier: 2022JC009
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Based on the current background and our previous studies, TUS has been proved that rTUS intervention could induce long-term potentiation like (LTP-like) plasticity and neuromodulate the brain cortex in schizophrenia patients. rTUS over the left dorsolateral prefrontal cortex (DLPFC) can alleviate the negative symptoms in schizophrenia. In this double-blind, randomized, sham-controlled study, the efficacy of different treatment options and mechanisms of low-intensity rTUS on negative symptoms will be investigated.

Conditions

Negative Symptoms of Schizophrenia

Keywords

Schizophrenia; Negative Symptoms; Transcranial Ultrasound Stimulation

Outcome Measures

Primary Outcomes (3)

• Change from baseline in the Brief Negative Symptom Scale (BNSS)

  Change from baseline in the Brief Negative Symptom Scale (BNSS) at 4 weeks and 8 weeks. The minimum to maximum value is 0-78. Lower scores mean a better outcome.

  baseline, 4 weeks and 8 weeks

• Change from baseline in the Scale for Assessment of Negative Symptoms(SANS)

  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.

  baseline, 4 weeks and 8 weeks

• Change from baseline in Positive and Negative Syndrome Scale(PANSS)

  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.

  baseline, 4 weeks and 8 weeks

Secondary Outcomes (6)

• Change of cognitive Function

  baseline, 4 weeks and 8 weeks

• Change of Multi-modal Brain Neuroimaging in structure

  baseline and 4 weeks

• Change of Multi-modal Brain Neuroimaging in resting- state fMRI

  baseline and 4 weeks

• Change of Multi-modal Brain Neuroimaging in 1H-MRS

  baseline and 4 weeks

• Change of EEG microstates

  baseline and 4 weeks

Study Arms (3)

single-target group (left DLPFC)

ACTIVE COMPARATOR

27 eligible patients will be treated with active TUS for 4 weeks on the left DLPFC

Device: low-intensity transcranial ultrasound stimulation (TUS)

both-target group (both left DLPFC and right STG)

ACTIVE COMPARATOR

27 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)

sham group

SHAM COMPARATOR

27 eligible patients will be treated with sham TUS for 4 weeks on the left DLPFC and right STG, respectively.

Device: low-intensity transcranial ultrasound stimulation (TUS)

Interventions

low-intensity transcranial ultrasound stimulation (TUS) DEVICE

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).

both-target group (both left DLPFC and right STG); sham group; single-target group (left DLPFC)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Dengtang LIU

CONTACT

021-34773434; liudengtang@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 14, 2023
• Study Start: December 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)