SchizophreniaNCT05282329
Efficacy of tACS for Treatment of Auditory Hallucinations in Refractory Schizophrenia
A study testing Transcranial alternating Current Stimulation (tACS)-active in people with Schizophrenia, run by Tianjin Anding Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Transcranial alternating Current Stimulation (tACS)-active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 21 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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。
Read the 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
- Being tested
- Transcranial alternating Current Stimulation (tACS)-active, Transcranial Alternating Current Stimulation (tACS)-sham
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternating Current Stimulation (tACS)-activeDevice
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.
Transcranial Alternating Current Stimulation (tACS)-shamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tACS group | Experimental | 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. Receives: Device: Transcranial alternating Current Stimulation (tACS)-active |
| Sham group | Sham comparator | Controls received sham stimulation with the same protocol. Receives: Device: Transcranial Alternating Current Stimulation (tACS)-sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, week 2, week 4, week 6
Secondary outcomes (6)
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.
Measured: baseline, week 2, week 4, week 6
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.
Measured: baseline, week 2, week 4, week 6
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.
Measured: baseline, 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.
Measured: baseline, week 4, week 6
The change of scores of Adverse events scale from baseline to week 4
The aim is to evaluate the adverse effects during the treatment.
Measured: week 1, week 2, week 3, week 4
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.
Measured: baseline, week4, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Sep 2020
- Primary completion31 Aug 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282329
- Sponsor's protocol ID
- tACS-TJAH
- Status last verified
- Sep 2022
- First submitted
- 14 Feb 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05282329
- Acronym / sponsor ID
- tACS-TJAH
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tACS group | Experimental | Device: Transcranial alternating Current Stimulation (tACS)-activeParticipants 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. |
| Sham group | Sham comparator | Device: Transcranial Alternating Current Stimulation (tACS)-shamControls received sham stimulation with the same protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%)
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial alternating Current Stimulation (tACS)-activeTranscranial 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 | tACS group |
| Transcranial Alternating Current Stimulation (tACS)-shamTranscranial 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. | Device | Sham group |
Primary outcome
The change over time in the score of Psychotic Symptom Rating Scales (PSYRATS)
Time frame: baseline, week 2, week 4, week 6
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.
6 secondary outcomes
The change over time in the score of Hamilton Depression Rating Scale (HAMD-17)
Time frame: baseline, week 2, week 4, week 6
The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)
Time frame: baseline, week 2, week 4, week 6
The change of scores in cognition
Time frame: baseline, week 4
The changes of levels of Brain Derived Neurotrophic Factor in peripheral blood from baseline to week 6
Time frame: baseline, week 4, week 6
The change of scores of Adverse events scale from baseline to week 4
Time frame: week 1, week 2, week 3, week 4
The change of Gamma band activity before and after intervention
Time frame: baseline, week4, week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating Current Stimulation (tACS)-active in people with Schizophrenia, run by Tianjin Anding Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change over time in the score of Psychotic Symptom Rating Scales (PSYRATS) (time frame: baseline, week 2, week 4, week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.