Clinical trial NCT05282329: Efficacy of tACS for Treatment of Auditory Hallucinations in Refractory Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Tianjin Anding Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Eligible participants aged 18-70 with DSM-5-defined schizophrenia or schizophrenia-like disorder.
2. Duration of illness \> 12 weeks.
3. Being clinically stable and on an adequate therapeutic dose of antipsychotics for at least 8 weeks prior to enrolment.
4. Junior high school education or above
5. 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%)
6. Agreement to participate in the study and provide the written informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: The change over time in the score of Psychotic Symptom Rating Scales (PSYRATS)
timeFrame: baseline, week 2, week 4, week 6
Secondary outcomes:
measure: The change over time in the score of Hamilton Depression Rating Scale (HAMD-17)
timeFrame: baseline, week 2, week 4, week 6
measure: The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)
timeFrame: baseline, week 2, week 4, week 6
measure: The change of scores in cognition
timeFrame: baseline, week 4
measure: The changes of levels of Brain Derived Neurotrophic Factor in peripheral blood from baseline to week 6
timeFrame: baseline, week 4, week 6
measure: The change of scores of Adverse events scale from baseline to week 4
timeFrame: week 1, week 2, week 3, week 4
measure: The change of Gamma band activity before and after intervention
timeFrame: baseline, week4, week 6
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
Study officials:
References: