NCT05282329

Efficacy of tACS for Treatment of Auditory Hallucinations in Refractory Schizophrenia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Tianjin Anding Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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。

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	Transcranial alternating Current Stimulation (tACS)-active	Transcranial alternating current stimulation (tACS) employs a weak electric current for non-invasive brain stimulation with a sine-wave waveform, targeting brain oscillations in a frequency-specific manner. daily tACS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Participants were administered 2 mA alternating current delivered with gamma frequency, delivered over the temporal lobe.
DEVICE	Transcranial Alternating Current Stimulation (tACS)-sham	Transcranial alternating current stimulation (tACS) employs a weak electric current for non-invasive brain stimulation with a sine-wave waveform, targeting brain oscillations in a frequency-specific manner. Controls received sham stimulations with the same protocol.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-08-31
• Completion: 2022-09-21
• First posted: 2022-03-16
• Last updated: 2022-10-07

Locations

1 site across 1 country: China