SchizophreniaTDCSHALLUNCT04352569
Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia
A study testing transcranial direct current stimulation in people with Schizophrenia and Hallucinations, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial summary
The regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Hallucinations, Refractory Schizophrenia
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2016to 31 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia according to DSM-V.
- Refractory auditory hallucinations(despite two antipsychotics trials).
- Right-handed patients.
- Written informed consent.
Who cannot join
- Presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ).
- History of severe head trauma or coma.
- History of epilepsy or neurological disorder or a general medical condition.
- Presence of intracranial metallic objects or pacemaker.
- Hospitalized patients without consent.
- pregnant women .
Trial locations and contacts
1 site in 1 country.
France1 site
unité de recherche clinique de l'E.P.S de Ville Evrard
Neuilly-sur-Marne, 93332
About this study
Official title: Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study
The regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region.
To assess the efficacy of tDCS on auditory hallucinations, the investigators performs an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks.
Read the detailed description
Hearing hallucinations are one of the major symptoms of schizophrenia. In 30% of patients they are resistant to common psychotropic treatments. tDCS (Transcranial Direct Current Stimulation) is a technical of brain stimulation, non-invasive, painless that modulates brain activity by the transcranial administration of a low-intensity electric current, via two electrodes (an anode and a cathode). Several scientifics studies have reported a beneficial effect of tDCS in the treatment of pain, depression and especially hearing hallucinations in schizophrenia.
The main study purpose is to evaluate the effectiveness of tDCS on resistant auditory hallucinations in patients with schizophrenia.
Then, to evaluate the effectiveness of tDCS on global schizophrenic symptomatology and to assess the impact of tDCS on patients' quality of life.
Also the study, evaluate the impact of tDCS on cortical excitability. We measure the change in serum BDNF (Brain Derived Neutrophic Factor) before and after tDCS stimulation. Indeed, to evaluate the impact of tDCS on neurocognitive functions.
Patients will receive either active tDCS or placebo tDCS randomly. All patients will have two tDCS/day sessions, one hour apart, for 2 working weeks. The stimulation parameters will be consistent with the literature data, namely: Intensity = 2mA; duration of sessions = 20 minutes; total number of sessions = 20 (2 daily sessions for two working weeks).
- Conditions
- Schizophrenia, Hallucinations, Refractory Schizophrenia
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Schizophrenia, Hallucinations, Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called tDCS
transcranial direct current stimulation (tDCS) is a non invasive brain stimulation technic
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation | Active comparator | The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the LTP, le cathode over L DLPFG. Receives: Device: transcranial direct current stimulation |
| transcranial direct current stimulation sham | Sham comparator | tDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
auditory hallucinations rating scale (AHRS)
AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).
Measured: At baseline
auditory hallucinations rating scale (AHRS)
AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).
Measured: 15 days after
Secondary outcomes (4)
PANSS,
Positive and negative symptom scale (PANSS, Kay et al. 1988)
Measured: At baseline
PANSS,
Positive and negative symptom scale (PANSS, Kay et al. 1988)
Measured: 15 days after
CGI
clinical global impression (Kadouri et al. 2007)
Measured: At baseline
CGI
clinical global impression (Kadouri et al. 2007)
Measured: 15 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start3 May 2016
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noomane Bouaziz, MD, Centre hospitalier de Ville-Evrard, France
- Investigators
- NOOMANE BOUAZIZ, MD, Principal investigator, Unité de Recherche Clinique de l'EPS de Ville Evard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352569
- Sponsor's protocol ID
- TDCS-HALLU-2015-A00842-47
- Acronym
- TDCSHALLU
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2015
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04352569
- Acronym / sponsor ID
- TDCSHALLU / TDCS-HALLU-2015-A00842-47
- Conditions
- Schizophrenia, Hallucinations, Refractory Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 3 May 2016 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 20 Apr 2020 (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 regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region.
To assess the efficacy of tDCS on auditory hallucinations, the investigators performs an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks.
Detailed description
Hearing hallucinations are one of the major symptoms of schizophrenia. In 30% of patients they are resistant to common psychotropic treatments. tDCS (Transcranial Direct Current Stimulation) is a technical of brain stimulation, non-invasive, painless that modulates brain activity by the transcranial administration of a low-intensity electric current, via two electrodes (an anode and a cathode). Several scientifics studies have reported a beneficial effect of tDCS in the treatment of pain, depression and especially hearing hallucinations in schizophrenia.
The main study purpose is to evaluate the effectiveness of tDCS on resistant auditory hallucinations in patients with schizophrenia.
Then, to evaluate the effectiveness of tDCS on global schizophrenic symptomatology and to assess the impact of tDCS on patients' quality of life.
Also the study, evaluate the impact of tDCS on cortical excitability. We measure the change in serum BDNF (Brain Derived Neutrophic Factor) before and after tDCS stimulation. Indeed, to evaluate the impact of tDCS on neurocognitive functions.
Patients will receive either active tDCS or placebo tDCS randomly. All patients will have two tDCS/day sessions, one hour apart, for 2 working weeks. The stimulation parameters will be consistent with the literature data, namely: Intensity = 2mA; duration of sessions = 20 minutes; total number of sessions = 20 (2 daily sessions for two working weeks).
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 |
|---|---|---|
| transcranial direct current stimulation | Active comparator | Device: transcranial direct current stimulationThe transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the LTP, le cathode over L DLPFG. |
| transcranial direct current stimulation sham | Sham comparator | Device: transcranial direct current stimulationtDCS device allows sham stimulation. This technic give the same impression that active stimulation and allows optimum placebo stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Schizophrenia according to DSM-V.
- Refractory auditory hallucinations(despite two antipsychotics trials).
- Right-handed patients.
- Written informed consent.
Key exclusion criteria (6 listed)
- Presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ).
- History of severe head trauma or coma.
- History of epilepsy or neurological disorder or a general medical condition.
- Presence of intracranial metallic objects or pacemaker.
- Hospitalized patients without consent.
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 direct current stimulationAlso: tDCStranscranial direct current stimulation (tDCS) is a non invasive brain stimulation technic | Device | transcranial direct current stimulation, transcranial direct current stimulation sham |
Primary outcome
auditory hallucinations rating scale (AHRS)
Time frame: At baseline
AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).
auditory hallucinations rating scale (AHRS)
Time frame: 15 days after
AHRS is a scale frequently used to assess auditory hallucinations in schizophrenia studies (Hoffman et al. 2005).
4 secondary outcomes
PANSS,
Time frame: At baseline
PANSS,
Time frame: 15 days after
CGI
Time frame: At baseline
CGI
Time frame: 15 days after
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 6 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
NOOMANE BOUAZIZ, MD principal investigator
Unité de Recherche Clinique de l'EPS de Ville Evard
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 direct current stimulation in people with Schizophrenia and Hallucinations, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
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 4 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 6 Aug 2026. 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 France. 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?
auditory hallucinations rating scale (AHRS) (time frame: At baseline). The study lists 2 primary outcomes in all. 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 6 Aug 2026.