SchizophreniaNCT00870909
Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia
A study testing active tDCS in people with Schizophrenia and Auditory Hallucinations, run by Hôpital le Vinatier at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is effective in the treatment of auditory hallucinations in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Auditory Hallucinations
- What is being tested?
- active tDCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Feb 2009to 20 Jul 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia according to Diagnostic and Statistical Manual - DSM-IV
- Auditory verbal hallucinations for at least 6 weeks (despite antipsychotic drugs)
- Medication Resistance according to Kane et al., 1988
- Age between 18 and 50 years old
- Informed consent
Who cannot join
- Concomitant major and unstable medical or neurologic illness
- Pregnant
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Tunisia1 site
Laboratoire de Recherche " Vulnérabilité Aux Psychoses "
Monastir
About this study
Official title: Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia
The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is effective in the treatment of auditory hallucinations in schizophrenia.
Read the detailed description
The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect.
Using anodal \& cathodal tDCS the investigators aimed to treat auditory hallucinations, a symptoms of schizophrenia. The investigators plan to apply tDCS such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active stimulation will be compare to a sham condition in 60 patients (30 in each group). 30 patients will be included in a French center (Hospital le Vinatier, sponsor of the study) and 30 in Tunisia (laboratory "vulnerability to psychosis" (Pr Gaha) à Monastir).
- Conditions
- Schizophrenia, Auditory Hallucinations
- Being tested
- active tDCS, sham 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 tDCSProcedure or surgery
Also called tDCS, transDirect Current Stimulation, Anodal tDCS, Cathodal tDCS
Intensity 2 mA during 20 minutes, 2 times per day
sham tDCSProcedure or surgery
Also called tDCS placebo
sham condition as delivered by the stimulator
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Active comparator | tDCS active; - Intensity = 2 milliamps (mA) during 20 minutes. ramp up/ramp down 30sec anodal tDCS applied over the left DLPFC combined with cathodal tDCS applied over the left temporoparietal junction (TPJ).
10 sessions, 2 per day Receives: Procedure: active tDCS |
| sham tDCS | Placebo comparator | tDCS placebo same electrode montage than in the active group. 30 sec of active tDCS in the beginning of the stimulation sessions; ramp up/ramp down 30 sec Receives: Procedure: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003)
Measured: before, after 1 week of treatment and 2 times follow up (1 & 3 months)
Secondary outcomes (1)
Neurochemical impact of treatment measured by 1H-MRS (proton Magnetic Resonance Spectroscopy), DTI (Diffusion Tensor Imaging) and resting MRI
Measured: 3 times: before treatment, immediately after treatment and a last evaluation 1 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study start2 Feb 2009
- Primary completion21 Apr 2016
- Study completion20 Jul 2016
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.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- emmanuel poulet, MD, PhD, Principal investigator, Hopital Le VinatierJEROME BRUNELIN, PhD, Study director, Hopital le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870909
- Sponsor's protocol ID
- 2008-A01226-49
- Status last verified
- Feb 2017
- First submitted
- 26 Mar 2009
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia
- ClinicalTrials.gov ID
- NCT00870909
- Acronym / sponsor ID
- 2008-A01226-49
- Conditions
- Schizophrenia, Auditory Hallucinations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 2 Feb 2009 (actual)
- Primary completion
- 21 Apr 2016 (actual)
- Study completion
- 20 Jul 2016 (actual)
- First posted
- 27 Mar 2009 (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 purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is effective in the treatment of auditory hallucinations in schizophrenia.
Detailed description
The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect.
Using anodal \& cathodal tDCS the investigators aimed to treat auditory hallucinations, a symptoms of schizophrenia. The investigators plan to apply tDCS such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active stimulation will be compare to a sham condition in 60 patients (30 in each group). 30 patients will be included in a French center (Hospital le Vinatier, sponsor of the study) and 30 in Tunisia (laboratory "vulnerability to psychosis" (Pr Gaha) à Monastir).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Active comparator | Procedure: active tDCStDCS active; - Intensity = 2 milliamps (mA) during 20 minutes. ramp up/ramp down 30sec anodal tDCS applied over the left DLPFC combined with cathodal tDCS applied over the left temporoparietal junction (TPJ). 10 sessions, 2 per day |
| sham tDCS | Placebo comparator | Procedure: sham tDCStDCS placebo same electrode montage than in the active group. 30 sec of active tDCS in the beginning of the stimulation sessions; ramp up/ramp down 30 sec |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Schizophrenia according to Diagnostic and Statistical Manual - DSM-IV
- Auditory verbal hallucinations for at least 6 weeks (despite antipsychotic drugs)
- Medication Resistance according to Kane et al., 1988
- Age between 18 and 50 years old
- Informed consent
Key exclusion criteria (2 listed)
- Concomitant major and unstable medical or neurologic illness
- Pregnant
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 tDCSAlso: tDCS, transDirect Current Stimulation, Anodal tDCS, Cathodal tDCSIntensity 2 mA during 20 minutes, 2 times per day | Procedure or surgery | active tDCS |
| sham tDCSAlso: tDCS placebosham condition as delivered by the stimulator | Procedure or surgery | sham tDCS |
Primary outcome
Auditory hallucinations measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003)
Time frame: before, after 1 week of treatment and 2 times follow up (1 & 3 months)
1 secondary outcome
Neurochemical impact of treatment measured by 1H-MRS (proton Magnetic Resonance Spectroscopy), DTI (Diffusion Tensor Imaging) and resting MRI
Time frame: 3 times: before treatment, immediately after treatment and a last evaluation 1 month 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 1 Mar 2017.
- Derived from this study: 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.
emmanuel poulet, MD, PhD principal investigator
Hopital Le Vinatier
JEROME BRUNELIN, PhD study director
Hopital le Vinatier
2 sites in 2 countries: 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 and Auditory Hallucinations, run by Hôpital le Vinatier at 2 sites in 2 countries.
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 5 inclusion and 2 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Tunisia. 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 measured by Auditory Hallucination Rating Scale (Hoffman et al., 2003) (time frame: before, after 1 week of treatment and 2 times follow up (1 & 3 months)). 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 NCT00870909, 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 1 Mar 2017.