Back to resultsEfficacy of tACS for Treatment of Auditory Hallucinations in Refractory Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial alternating Current Stimulation (tACS)-active
Transcranial Alternating Current Stimulation (tACS)-sham
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- Tianjin Anding Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
tACS group
Sham group
Arm Description
Participants receive tACS 20-min sessions in a 5-day sequence for four consecutive weeks,combined with original and stable medication. Active group participants were administered 2 mA alternating current delivered with gamma frequency, delivered over the temporal lobe.
Controls received sham stimulation with the same protocol.
Outcomes
Primary Outcome Measures
The change over time in the score of Psychotic Symptom Rating Scales (PSYRATS)
The main objective is to explore whether tACS combined with antipsychotics could improve refractory auditory hallucinations in schizophrenia after 4-week treatment. PSYRATS were assessed at baseline and week 2, 4, 6. Higher total score of the scale means more severe auditory hallucinations symptoms.
Secondary Outcome Measures
The change over time in the score of Hamilton Depression Rating Scale (HAMD-17)
The change over time in the score of Hamilton Depression Rating Scale (HAMD-17)The aim is to explore whether tACS combined with antipsychotics could alleviate the severity of depressive symptoms as measured with HAMD-17 in refractory schizophrenia after 4-week treatment. Hamilton Depression Rating Scale (HAMD-17) was used to evaluate the severity of symptoms of depression. Higher total score of the scale means more severe depressive symptoms.
The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)
The aim is to explore whether tACS combined with antipsychotics could alleviate the severity of anxious symptoms as measured with HAMA in refractory schizophrenia after 4-week treatment. Hamilton Anxiety Rating Scale (HAMA) was used to evaluate the severity of symptoms of anxiety. Higher total score of the scale means more severe anxious symptoms.
The change of scores in cognition
The aim is to observe whether active-stimuli in addition to regular treatment with antipsychotics will improve the cognitive function as measured with the MATRICS Consensus Cognitive Battery after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4.
The changes of levels of Brain Derived Neurotrophic Factor in peripheral blood from baseline to week 6
The aim is to investigate the change of Brain Derived Neurotrophic Factor level in peripheral blood as active stimuli in addition to regular medical treatment after 4 weeks of treatment compared to sham stimuli, and EDTA tubes were used to collect 5ml of peripheral blood at baseline, weeks 4, and 6 before feeding. The plasma was extracted after centrifugation, and the concentration of BDNF in plasma was detected by ELISA.
The change of scores of Adverse events scale from baseline to week 4
The aim is to evaluate the adverse effects during the treatment.
The change of Gamma band activity before and after intervention
The aim is to observe the changes in gamma band activity before and after intervention. EEG signals were recorded at baseline, 4 and 6 weeks. Gamma has been interpreted as an imbalance between excitation and inhibition, and is significantly associated with positive symptoms in schizophrenia. Changes in Gamma PSD before and after intervention were calculated by resting state EEG. In addition, 40hz - auditory homeostasis was collected to calculate whether the power of auditory evoked potentials changed before and after the intervention.
Full Information
NCT ID
NCT05282329
First Posted
February 14, 2022
Last Updated
October 5, 2022
Sponsor
Tianjin Anding Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05282329
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Anding Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tACS group
Arm Type
Experimental
Arm Description
Participants receive tACS 20-min sessions in a 5-day sequence for four consecutive weeks,combined with original and stable medication. Active group participants were administered 2 mA alternating current delivered with gamma frequency, delivered over the temporal lobe.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Controls received sham stimulation with the same protocol.
Intervention Type
Device
Intervention Name(s)
Transcranial alternating Current Stimulation (tACS)-active
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Alternating Current Stimulation (tACS)-sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change over time in the score of Psychotic Symptom Rating Scales (PSYRATS)
Description
The main objective is to explore whether tACS combined with antipsychotics could improve refractory auditory hallucinations in schizophrenia after 4-week treatment. PSYRATS were assessed at baseline and week 2, 4, 6. Higher total score of the scale means more severe auditory hallucinations symptoms.
Time Frame
baseline, week 2, week 4, week 6
Secondary Outcome Measure Information:
Title
The change over time in the score of Hamilton Depression Rating Scale (HAMD-17)
Description
The change over time in the score of Hamilton Depression Rating Scale (HAMD-17)The aim is to explore whether tACS combined with antipsychotics could alleviate the severity of depressive symptoms as measured with HAMD-17 in refractory schizophrenia after 4-week treatment. Hamilton Depression Rating Scale (HAMD-17) was used to evaluate the severity of symptoms of depression. Higher total score of the scale means more severe depressive symptoms.
Time Frame
baseline, week 2, week 4, week 6
Title
The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)
Description
The aim is to explore whether tACS combined with antipsychotics could alleviate the severity of anxious symptoms as measured with HAMA in refractory schizophrenia after 4-week treatment. Hamilton Anxiety Rating Scale (HAMA) was used to evaluate the severity of symptoms of anxiety. Higher total score of the scale means more severe anxious symptoms.
Time Frame
baseline, week 2, week 4, week 6
Title
The change of scores in cognition
Description
The aim is to observe whether active-stimuli in addition to regular treatment with antipsychotics will improve the cognitive function as measured with the MATRICS Consensus Cognitive Battery after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline and week 4.
Time Frame
baseline, week 4
Title
The changes of levels of Brain Derived Neurotrophic Factor in peripheral blood from baseline to week 6
Description
The aim is to investigate the change of Brain Derived Neurotrophic Factor level in peripheral blood as active stimuli in addition to regular medical treatment after 4 weeks of treatment compared to sham stimuli, and EDTA tubes were used to collect 5ml of peripheral blood at baseline, weeks 4, and 6 before feeding. The plasma was extracted after centrifugation, and the concentration of BDNF in plasma was detected by ELISA.
Time Frame
baseline, week 4, week 6
Title
The change of scores of Adverse events scale from baseline to week 4
Description
The aim is to evaluate the adverse effects during the treatment.
Time Frame
week 1, week 2, week 3, week 4
Title
The change of Gamma band activity before and after intervention
Description
The aim is to observe the changes in gamma band activity before and after intervention. EEG signals were recorded at baseline, 4 and 6 weeks. Gamma has been interpreted as an imbalance between excitation and inhibition, and is significantly associated with positive symptoms in schizophrenia. Changes in Gamma PSD before and after intervention were calculated by resting state EEG. In addition, 40hz - auditory homeostasis was collected to calculate whether the power of auditory evoked potentials changed before and after the intervention.
Time Frame
baseline, week4, week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy of tACS for Treatment of Auditory Hallucinations in Refractory Schizophrenia
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