Efficacy of tACS for Treatment of Auditory Hallucinations in Refractory Schizophrenia

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    40
  • sponsor
    Tianjin Anding Hospital
Updated on 9 May 2022
antipsychotics
hallucinations
chlorpromazine
auditory hallucinations

Summary

The aim of this study is to evaluate the feasibility and efficacy of transcranial alternating current stimulation (tACS) as an add-on treatment for auditory hallucinations in refractory schizophrenia. Meanwhile, we aim to evaluate the effect of tACS on cognitive function of schizophrenia patients. we hypothesize tACS would improve refractory auditory hallucination symptoms in schizophrenia by regulating the gamma frequency band of temporal lobe。

Description

This is a randomized, double-blind, sham-controlled study to detect the effect of tACS for treatment of refractory auditory hallucinations in schizophrenia. 66 participants were randomly assigned 1:1 to tACS group or sham-control group. For both active and sham group, daily tACS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, active participants were administered 2 mA alternating current delivered with gamma frequency, delivered over the temporal lobe, while controls received sham stimulations with the same protocol. Scale assessments are performed at baseline, week 2, week 4 and week 6. Collection of blood took place at baseline, week 4 and week 6.

Details
Condition Schizophrenia
Treatment Transcranial alternating Current Stimulation (tACS)-active, Transcranial Alternating Current Stimulation (tACS)-sham
Clinical Study IdentifierNCT05282329
SponsorTianjin Anding Hospital
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible participants aged 18-70 with DSM-5-defined schizophrenia or schizophrenia-like disorder
Duration of illness > 12 weeks
Being clinically stable and on an adequate therapeutic dose of antipsychotics for at least 8 weeks prior to enrolment
Junior high school education or above
After treatment with ≥ 2 different antipsychotics (greater than the equivalent dose of chlorpromazine 600mg), the curative effect was poor (CGI ≥ 4 points or the PANSS score reduction rate since this treatment was less than 20%)
Agreement to participate in the study and provide the written informed consent

Exclusion Criteria

Having unstable medical conditions, current psychiatric comorbidity or active substance use disorder (in exception to caffeine and/or tobacco)
Having Serious physical diseases or nervous system diseases
Having any brain device / implant, including cochlear implant and aneurysm clip
Having a history or family history of autoimmune diseases or immune diseases
Pregnancy or breastfeeding at enrollment
Skin lesions on scalp at the area of electrode application
Clear my responses

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