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Efficacy of Transcranial Alternating Current Stimulation (tACS) as an Add-on Treatment for Auditory Hallucinations in Refractory Schizophrenia: A Randomized, Double-blind, Sham-controlled Trial
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。
This is a randomized, double-blind, sham-controlled study to detect the effect of tACS for treatment of refractory auditory hallucinations in schizophrenia. 50 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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China
Start Date
September 1, 2020
Primary Completion Date
August 31, 2022
Completion Date
September 21, 2022
Last Updated
October 7, 2022
50
ACTUAL participants
Transcranial alternating Current Stimulation (tACS)-active
DEVICE
Transcranial Alternating Current Stimulation (tACS)-sham
DEVICE
Lead Sponsor
Tianjin Anding Hospital
NCT07455929
NCT06740383
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