SchizophreniaNCT05159336
Transcranial Alternating Current Stimulation (tACS) for Auditory Hallucinations
A study testing tACS for auditory hallucinations via single arm in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Transcranial alternating current stimulation (tACS) can modulate and restore neural oscillations that are reduced in patients with psychiatric illnesses such as schizophrenia. Here, we performed a open-lable study of clinical trial in 30 schizophrenia patients with auditory hallucinations to show that tACS is… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- tACS for auditory hallucinations via single arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2021to 28 May 2023
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Schizophrenia with auditory hallucinations was diagnosed by DSM-IV, AHRS >12, Take sufficient antipsychotics for at least 1 month.
Who cannot join
- current pregnancy, major medical illness affecting the central nervous system, significant neurologic disorders, intake of drugs including supplements like essential fatty acids that influence prostaglandins or niacin skin flush flash pathway metabolism, a history of suicide risk, or alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, 021
Yegang Hu, Doctor, 021-52219305, yeganghu@126.com
About this study
Official title: Intervention Treatment of Auditory Hallucination by Transcranial Alternating Current Stimulation
Transcranial alternating current stimulation (tACS) can modulate and restore neural oscillations that are reduced in patients with psychiatric illnesses such as schizophrenia. Here, we performed a open-lable study of clinical trial in 30 schizophrenia patients with auditory hallucinations to show that tACS is effective for auditory hallucinations.
Read the detailed description
Each week, the patient rested quietly with her eyes open while receiving alpha-frequency tACS for 40 minutes. Stimulation was delivered at 10 Hz with 1 mA zero-to-peak amplitude in-phase to the location 1 and the location 2 acquired by the MEG technique with 5*5 cm electrodes. A 5* 7 cm return electrode was centered on Cz. In total, 20 weeks.
- Conditions
- Schizophrenia
- Being tested
- tACS for auditory hallucinations via single arm
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACS for auditory hallucinations via single armDevice
a 20 weeks, weekly 40 minutes, 1mA, 10Hz-tACS protocol
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia patients with auditory hallucinations | Experimental | For schizophrenia patients with auditory hallucinations, tACS for implementation intervention Receives: Device: tACS for auditory hallucinations via single arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Auditory Hallucination Scale(the minimum is 0, maximum value is 47, and higher scores mean a worse outcome)
Reduction rate of AHRS scale
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start16 Nov 2021
- Primary completion30 Mar 2023 (estimated)
- Study completion28 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yegang Hu, Doctor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159336
- Sponsor's protocol ID
- NDYX20211101
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Force RB, Riddle J, Jarskog LF, Frohlich F. A case study of the feasibility of weekly tACS for the treatment of auditory hallucinations in schizophrenia. Brain Stimul. 2021 Mar-Apr;14(2):361-363. doi: 10.1016/j.brs.2021.01.014. Epub 2021 Jan 27. No abstract available.
PubMed 33515747Ahn S, Mellin JM, Alagapan S, Alexander ML, Gilmore JH, Jarskog LF, Frohlich F. Targeting reduced neural oscillations in patients with schizophrenia by transcranial alternating current stimulation. Neuroimage. 2019 Feb 1;186:126-136. doi: 10.1016/j.neuroimage.2018.10.056. Epub 2018 Oct 24.
PubMed 30367952
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Treatment of Auditory Hallucination by Transcranial Alternating Current Stimulation
- ClinicalTrials.gov ID
- NCT05159336
- Acronym / sponsor ID
- NDYX20211101
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 28 May 2023 (estimated)
- First posted
- 16 Dec 2021 (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.
Transcranial alternating current stimulation (tACS) can modulate and restore neural oscillations that are reduced in patients with psychiatric illnesses such as schizophrenia. Here, we performed a open-lable study of clinical trial in 30 schizophrenia patients with auditory hallucinations to show that tACS is effective for auditory hallucinations.
Detailed description
Each week, the patient rested quietly with her eyes open while receiving alpha-frequency tACS for 40 minutes. Stimulation was delivered at 10 Hz with 1 mA zero-to-peak amplitude in-phase to the location 1 and the location 2 acquired by the MEG technique with 5*5 cm electrodes. A 5* 7 cm return electrode was centered on Cz. In total, 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| schizophrenia patients with auditory hallucinations | Experimental | Device: tACS for auditory hallucinations via single armFor schizophrenia patients with auditory hallucinations, tACS for implementation intervention |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Schizophrenia with auditory hallucinations was diagnosed by DSM-IV, AHRS >12, Take sufficient antipsychotics for at least 1 month.
Key exclusion criteria (1 listed)
- current pregnancy, major medical illness affecting the central nervous system, significant neurologic disorders, intake of drugs including supplements like essential fatty acids that influence prostaglandins or niacin skin flush flash pathway metabolism, a history of suicide risk, or alcohol or drug abuse.
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 |
|---|---|---|
| tACS for auditory hallucinations via single arma 20 weeks, weekly 40 minutes, 1mA, 10Hz-tACS protocol | Device | schizophrenia patients with auditory hallucinations |
Primary outcome
Evaluation of Auditory Hallucination Scale(the minimum is 0, maximum value is 47, and higher scores mean a worse outcome)
Time frame: One month
Reduction rate of AHRS scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Results publication: PubMed 33515747Force RB, Riddle J, Jarskog LF, Frohlich F. A case study of the feasibility of weekly tACS for the treatment of auditory hallucinations in schizophrenia. Brain Stimul. 2021 Mar-Apr;14(2):361-363. doi: 10.1016/j.brs.2021.01.014. Epub 2021 Jan 27. No abstract available.
- Results publication: PubMed 30367952Ahn S, Mellin JM, Alagapan S, Alexander ML, Gilmore JH, Jarskog LF, Frohlich F. Targeting reduced neural oscillations in patients with schizophrenia by transcranial alternating current stimulation. Neuroimage. 2019 Feb 1;186:126-136. doi: 10.1016/j.neuroimage.2018.10.056. Epub 2018 Oct 24.
- Individual participant dataSharing planned: No
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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.
Yegang Hu, Doctor principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS for auditory hallucinations via single arm in people with Schizophrenia, run by Shanghai Mental Health Center 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Dec 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yegang Hu, Doctor (021-52219305, yeganghu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Auditory Hallucination Scale(the minimum is 0, maximum value is 47, and higher scores mean a worse outcome) (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05159336, which also lists 2 linked publications.
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 16 Dec 2021; AzTrials last refreshed its copy on 30 Oct 2026.