Precise Intervention Technology and Application of Low Intensity Transcranial Ultrasound Stimulation (TUS) on Negative Symptoms of Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
Dengtang LIU
liudengtang@smhc.org.cn
021-34773434
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 81
Treatments
Active_comparator: single-target group (left DLPFC)
27 eligible patients will be treated with active TUS for 4 weeks on the left DLPFC
Active_comparator: both-target group (both left DLPFC and right STG)
27 eligible patients will be treated with active TUS for 4 weeks on the both left DLPFC and right STG
Sham_comparator: sham group
27 eligible patients will be treated with sham TUS for 4 weeks on the left DLPFC and right STG, respectively.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov