SchizophreniaNCT02227563
tDCS & Auditory Hallucinations in Schizophrenia
A study testing Active tDCS in people with Schizophrenia, run by Herzog Hospital at 1 site in Israel.
Trial summary
The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Aug 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-60
- Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia
- Persistent auditory verbal hallucinations
- Right handed
- Under stable doses of antipsychotic medication for ≥4 weeks
- Normal hearing by self-report and physical exam
- Use of effective method of birth control for women of childbearing capacity
- Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent
Who cannot join
- Current or past history of substance dependence or abuse (excluding nicotine)
- Other current Axis I disorders
- History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Frequent and persistent migraines
- History of adverse reaction to neurostimulation
- Participation in study of investigational medication within 6 weeks
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- Pregnancy
- Women who are breast-feeding
- Current significant laboratory abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: tDCS & Auditory Hallucinations in Schizophrenia (AVH-SZ)
The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.
- Conditions
- Schizophrenia
- Being tested
- Active tDCS, control
- Keywords
- dorsolateral prefrontal cortex, left superior temporal gyrus, auditory hallucinations, transcranial direct current stimulation (tDCS)
- Medical subject headings
- Schizophrenia, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
repetitive daily tDCS sessions for a period of one week
controlDevice
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | active tDCS Receives: Device: Active tDCS |
| control | Sham comparator | sham (placebo) tDCS condition Receives: Device: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in auditory hallucination rating scale
Measured: 1 week post-treatment
Secondary outcomes (1)
change in self-report quality of life scale from baseline
Measured: 1 week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Lack of participants that fit inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herzog Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oded Meiron, PhD, Principal investigator, Sarah Herzog Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227563
- Sponsor's protocol ID
- Meiron 2013-3
- Status last verified
- Aug 2016
- First submitted
- 20 May 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.
PubMed 22581236
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS & Auditory Hallucinations in Schizophrenia (AVH-SZ)
- ClinicalTrials.gov ID
- NCT02227563
- Acronym / sponsor ID
- Meiron 2013-3
- Conditions
- Schizophrenia
- Keywords
- dorsolateral prefrontal cortex, left superior temporal gyrus, auditory hallucinations, transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants that fit inclusion criteria
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Herzog HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Aug 2014 (estimated)
- 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 tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.
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 |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCSactive tDCS |
| control | Sham comparator | Device: controlsham (placebo) tDCS condition |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ages 18-60
- Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia
- Persistent auditory verbal hallucinations
- Right handed
- Under stable doses of antipsychotic medication for ≥4 weeks
Key exclusion criteria (9 listed)
- Current or past history of substance dependence or abuse (excluding nicotine)
- Other current Axis I disorders
- History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Frequent and persistent migraines
- History of adverse reaction to neurostimulation
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 |
|---|---|---|
| Active tDCSrepetitive daily tDCS sessions for a period of one week | Device | Active tDCS |
| control | Device | control |
Primary outcome
change from baseline in auditory hallucination rating scale
Time frame: 1 week post-treatment
1 secondary outcome
change in self-report quality of life scale from baseline
Time frame: 1 week post treatment
Results and safety
The study was stopped early (reason given: Lack of participants that fit inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 22581236Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.
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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.
Oded Meiron, PhD principal investigator
Sarah Herzog Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Schizophrenia, run by Herzog Hospital at 1 site in Israel.
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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Nov 2016. 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 Israel. 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 was stopped early (reason given: Lack of participants that fit inclusion criteria). Results are not available in the source record.
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?
change from baseline in auditory hallucination rating scale (time frame: 1 week post-treatment). 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 NCT02227563, which also lists 1 linked publication.
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 2 Nov 2016; AzTrials last refreshed its copy on 31 Oct 2026.