Mental DisordersSTIM'ZONCT02744989
STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia
A study testing Neuroconn or Neuroelectric tDCS stimulator in people with Mental Disorders and Schizophrenia, run by Hospices Civils de Lyon at 10 sites in 2 countries.
Trial summary
This project aims to provide the proof of concept for transcranial direct-current stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorders, Schizophrenia
- What is being tested?
- Neuroconn or Neuroelectric tDCS stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 30 May 2016to 19 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia according to DSM 5.0 (Diagnostic and Statistical Manuel 5.0) criteria
- Presence of symptoms despite the optimization of the antipsychotic dosage (based on prescriber's judgment) for at least 6 weeks, i.e. a dosage increase cannot be considered due to tolerability issues and/or is judged unlikely to bring sufficient clinical improvement. This will be operationalized by a minimum Negative PANSS score of 20 and at least one item scoring > 4; OR a minimum Positive PANSS score of 20 with at least one item scoring > 4 (e.g. delusion or hallucination), indicating persistent negative symptoms and/or persistent positive symptoms,
- Patient under curatorship/guardianship or not
- Age between 18 and 65 years old.
- Covered by, or having the right to Social Security
- Patient who understands the French language
- Informed consent signed
Who cannot join
- Other neuropsychiatric disorders (psychiatric history will be assessed using the MINI 6.0 (Mini International Neuropsychiatric Interview 6.0)) including bipolar disorders and mood depression disorders - (NB: Patients with substance related and addictive disorders will not be excluded from the study, but these data will be carefully recorded).
- Contraindications for tDCS (neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes),
- Increase in total composite PANSS score of at least 20% between screening and enrollment visits
- Women who are pregnant
- Patients whose clinical condition requires in patient procedure under constraint
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
France9 sites
Centre Hospitalier Le Vinatier - Service de Psychiatrie Adulte
Bron, 69678
Centre Esquirol - CHU de Caen - Service de Psychiatrie Adulte,
Caen, 14033
CHU de Clermont-Ferrand - Pôle de Psychiatrie B
Clermont-Ferrand, 63000
Hôpital Fontan - CHRU de Lille - Pôle de Psychiatrie
Lille, 59037
Hôpital Edouard Herriot - Service d'Urgences Psychiatriques
Lyon, 69437
Hôpital de la Colombière - CHU Montpellier - Service de Psychiatrie Adulte
Montpellier, 34295
Centre Hospitalier Saint-Anne - Service de Psychiatrie Adultes
Paris, 75014
CHU de St-Etienne - Service d'Urgences Psychiatriques
Saint-Etienne, 42055
CHRU de Tours - Clinique Psychiatrique Universitaire
Tours, 37044
Monaco1 site
Centre Hospitalier Princesse Grace - Service de Psychiatrie
Monaco, 98000
About this study
Official title: STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia (SCH)
This project aims to provide the proof of concept for transcranial direct-current stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed antipsychotic medication. An early optimization of the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In this study, stimulation is an add-on treatment to antipsychotic medication, and will be used in a broad variety of patients, i.e. in patients with varied durations of illness, various symptoms profiles, and various levels of treatment response. This in turn will allow the determination of the extent to which results can be generalized to varied patient populations, as well as the extent to which various therapeutic targets (e.g. different symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS. Despite interesting preliminary results, our team is unable to describe optimal non-invasive brain stimulation (NIBS) response markers.
This study is a randomized, double blind, controlled, French multicenter study (11 centers). The investigators plan to include 144 patients with persistent symptoms in schizophrenia. Seventy two subjects will receive active tDCS and 72 subjects will receive sham tDCS (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders, defined as a decrease of at least 25% of symptoms as measured by a standardized clinical scale score (PANSS) between baseline and after the 10-session tDCS regimen.
Furthermore, the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers. An analysis of the effects on cortical activity and plasticity markers could be an interesting approach.
- Conditions
- Mental Disorders, Schizophrenia
- Being tested
- Neuroconn or Neuroelectric tDCS stimulator, Sham tDCS
- Keywords
- Schizophrenia, Transcranial direct-current stimulation (tDCS), Sham, Positive and Negative Syndrome Scale (PANSS), Functional Magnetic Resonance Imaging (fRMI), Brain-Derived-Neurotrophic Factor (BDNF)
- Medical subject headings
- Mental Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroconn or Neuroelectric tDCS stimulatorDevice
Stimulation parameters were chosen in conformity with those for the treatment of schizophrenic symptoms (Brunelin et al, 2012), adapted according to the latest data from the literature and the tDCS operating stimulator. The experimental tDCS group will receive the ACTIVE stimulation with the following parameters: oscillatory Direct Current with high frequency random noise stimulation (hf-tRNS - 100 to 500 Hz), Intensity = 2 mA, offset = + 1 mA, seance duration = 20 minutes ramp up/ramp down 30 seconds. Total number of sessions = 10 (sessions twice daily for 5 days separated by at least 2 hours for 5 consecutive weekdays).
Sham tDCSDevice
The control group will receive the SHAM stimulation (placebo) following the same regimen (i.e., twice daily sessions separated by at least 2 hours for 5 consecutive weekdays). Sham stimulation consists of a 20 minutes session including 40 seconds of active stimulation (same parameters as in the ACTIVE arm) at the beginning of the sessions, whatever the stimulator
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Stimulation will be performed using an tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl). The anode will be placed with the middle of the electrode over a point midway between F3 and FP1 (left prefrontal cortex: dorsolateral prefrontal cortex, assumed to correspond to a region including Brodmann's Areas (BA) 8, 9, 10, and 46, depending on the patient). The cathode will be located over a point midway between T3 and P3 (left temporo-parietal junction, assumed to correspond to a region including BA 22, 39, 40, 41, and 42, depending on the patient). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day for 5 consecutive weekdays. The twice daily sessions will be separated by at least 2 hours. Receives: Device: Neuroconn or Neuroelectric tDCS stimulator |
| Sham tDCS | Sham comparator | Not described Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of responders
The number of responders is based on the Positive and Negative Syndrome Scale (PANSS) score in the active and the sham group after 5 days of tDCS.
According to Leucht et al (2009), response is defined as a decrease of at least 25% in the Positive and Negative Syndrome Scale (PANSS, Kay et al., 1987) score after the intervention.
Measured: Between baseline (day 0) and after 10-sessions of tDCS regimen (day 5)
Secondary outcomes (16)
Positive and Negative Syndrome Scale (PANSS) score
Long-term clinical efficacy of active tDCS on schizophrenic symptoms is assessed by PANSS score measured between baseline (day 0), after 10-sessions of tDCS regimen (day 5), 1 month after tDCS (day 30), 3 months after tDCS (day 90) and 6 months after tDCS (day 180).
The PANSS is a 30-item rater-administered assessment scale of the psychopathological symptoms observed in patients experiencing psychotic states, in particular schizophrenia. The items are noted from 1 to 7. It allows the calculation of the scores for three syndromic dimensions (positive, negative, and general psychopathology), both from a categorical and dimensional perspective. It is particularly recommended for determining a psychopathological profile, to look for predictive elements of an evolution, and to evaluate the respective efficacies of diverse therapeutic strategies.
Measured: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Auditory Hallucination Rating Scale (AHRS) score
Long-term clinical efficacy of active tDCS on schizophrenic symptoms is assessed by AHRS score measured between baseline (day 0), after 10-sessions of tDCS regimen (day 5), 1 month after tDCS (day 30), 3 months after tDCS (day 90) and 6 months after tDCS (day 180).
The AHRS score measures the severity of auditory hallucinations.
Measured: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Psycho-Sensory hAllucinations Scale (PSAS) score
Long-term clinical efficacy of active tDCS on schizophrenic symptoms is assessed by PSAS score measured between baseline (day 0), after 10-sessions of tDCS regimen (day 5), 1 month after tDCS (day 30), 3 months after tDCS (day 90) and 6 months after tDCS (day 180).
The PSAS score measures the delusions and severity of hallucinations
Measured: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Calgary Depression Scale for Schizophrenia (CDSS) score
Long-term clinical efficacy of active tDCS on schizophrenic symptoms is assessed by CDSS score measured between baseline (day 0), after 10-sessions of tDCS regimen (day 5), 1 month after tDCS (day 30), 3 months after tDCS (day 90) and 6 months after tDCS (day 180).
The CDSS score measures depression.
Measured: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Clinical Global Impression (CGI) score
Long-term clinical efficacy of active tDCS on schizophrenic symptoms is assessed by CGI score measured between baseline (day 0), after 10-sessions of tDCS regimen (day 5), 1 month after tDCS (day 30), 3 months after tDCS (day 90) and 6 months after tDCS (day 180).
The CGI score measures the severity of symptoms and response to treatment.
Measured: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Shortened Quality of Life questionnaire score
Quality of life is assessed by S-QoL18 (Shortened Quality of Life questionnaire) scale. S-QoL18 scale assesses eight dimensions : psychological well-being, self-esteem, family relationships, relationships with friends, resilience, physical well-being, autonomy and sentimental life.
Measured: Baseline and 6 months after the last tDCS session
Scale to assess Unawareness of Mental Disorder (SUMD) score
SMUD score (Scale to assess Unawareness of Mental Disorder score) assesses the effect of tDCS on patients' attitudes toward treatment of schizophrenia
Measured: Baseline and 3 months after the last tDCS session
Medication Adherence rating Scale (MARS) score
MARS score assesses the effect of tDCS on patients' attitudes toward treatment of schizophrenia
Measured: Baseline and 3 months after the last tDCS session
Brief Medication Questionnaire (BMQ) scores
BMQ scores (BMQ and BMQ tDCS) assesses the effect of tDCS on patients' attitudes toward treatment of schizophrenia
Measured: Baseline and 3 months after the last tDCS session
Source monitoring test score
Source memory test is performed at baseline and after 10-sessions of tDCS regimen to investigate the effect of tDCS on source monitoring capacities, a cognitive function that may underlie psychotic symptoms (Brunelin et al. 2006).
Measured: Baseline and day 5 (after 10-sessions of tDCS regimen)
Functional magnetic resonance imaging (MRI)
In order to evaluate treatment-related changes in functional brain connectivity, a functional MRI scans is performed at baseline (day 0), after 10-sessions of tDCS regimen (day 5) and 1 month after the last tDCS session (day 30).
Measured: Baseline, day 5 (after 10-sessions of tDCS regimen) and 1 month after the last tDCS session
Anatomical magnetic resonance imaging (MRI)
In order to evaluate treatment-related changes in functional brain connectivity, an anatomical MRI scans is performed at baseline (day 0), after 10-sessions of tDCS regimen (day 5) and 1 month after the last tDCS session (day 30).
Measured: Baseline, day 5 (after 10-sessions of tDCS regimen) and 1 month after the last tDCS session
Total serum Brain-Derived-Neurotrophic Factor (BDNF)
Total serum BDNF level is measured to investigate the association between neural markers and clinical response to tDCS. It is hypothised that total serum BDNF is a predictive neural marker of therapeutic response.
Measured: Baseline
Serum Brain-Derived-Neurotrophic Factor (BDNF) isoforms
Serum BDNF isoforms level is measured to investigate the association between neural markers and clinical response to tDCS. It is hypothised that serum BDNFisoforms is a predictive neural marker of therapeutic response.
Measured: Baseline
Self-evaluation of Negative Symptoms (SNS) score
The Self-evaluation of Negative Symptoms scale is a French self-administered questionnaire composed of 20 items organized into 5 domains of negative symptoms of schizophrenia (social withdrawal, diminished emotional range, alogia, avolition, anhedonia).
Measured: Baseline, 1 month and 3 months after the last tDCS session
Fargerström test score
The Fargerström test for nicotine dependence (FTND) is a short form includes six questions designed to estimate the degree of nicotine dependence in tobacco smoking.
Measured: Baseline, 1 month and 6 months after the last tDCS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start30 May 2016
- Primary completionMay 2022
- Study completion19 Oct 2022
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 Mental DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744989
- Sponsor's protocol ID
- 69HCL14_0446
- Acronym
- STIM'ZO
- Status last verified
- Dec 2025
- First submitted
- 18 Mar 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Brunelin J, Mondino M, Haesebaert J, Attal J, Benoit M, Chupin M, Dollfus S, El-Hage W, Galvao F, Jardri R, Llorca PM, Magaud L, Plaze M, Schott-Pethelaz AM, Suaud-Chagny MF, Szekely D, Fakra E, Poulet E. Examining transcranial random noise stimulation as an add-on treatment for persistent symptoms in schizophrenia (STIM'Zo): a study protocol for a multicentre, double-blind, randomized sham-controlled clinical trial. Trials. 2021 Dec 28;22(1):964. doi: 10.1186/s13063-021-05928-9.
PubMed 34963486
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia (SCH)
- ClinicalTrials.gov ID
- NCT02744989
- Acronym / sponsor ID
- STIM'ZO / 69HCL14_0446
- Conditions
- Mental Disorders, Schizophrenia
- Keywords
- Schizophrenia, Transcranial direct-current stimulation (tDCS), Sham, Positive and Negative Syndrome Scale (PANSS), Functional Magnetic Resonance Imaging (fRMI), Brain-Derived-Neurotrophic Factor (BDNF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 May 2016 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 20 Apr 2016 (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.
This project aims to provide the proof of concept for transcranial direct-current stimulation (tDCS) in the treatment of resistant/persistent Schizophrenia symptoms. The purpose is to investigate the effect of tDCS on symptoms in schizophrenic patients demonstrating a partial response to a first frequently prescribed antipsychotic medication. An early optimization of the therapeutic strategy must constitute an important factor for prognosis. Hypothesize is that tDCS should alleviate symptoms in patients depending on the clinical characteristics. In this study, stimulation is an add-on treatment to antipsychotic medication, and will be used in a broad variety of patients, i.e. in patients with varied durations of illness, various symptoms profiles, and various levels of treatment response. This in turn will allow the determination of the extent to which results can be generalized to varied patient populations, as well as the extent to which various therapeutic targets (e.g. different symptom dimensions, cognitive performance and brain connectivity) may be improved with tDCS. Despite interesting preliminary results, our team is unable to describe optimal non-invasive brain stimulation (NIBS) response markers.
This study is a randomized, double blind, controlled, French multicenter study (11 centers). The investigators plan to include 144 patients with persistent symptoms in schizophrenia. Seventy two subjects will receive active tDCS and 72 subjects will receive sham tDCS (placebo). Hypothesize is a lasting effect of active tDCS on the schizophrenic symptoms as measured by the number of responders, defined as a decrease of at least 25% of symptoms as measured by a standardized clinical scale score (PANSS) between baseline and after the 10-session tDCS regimen.
Furthermore, the participants believe that an in depth understanding of the cortical effects of tDCS could constitute an important step towards improving the technique and developing treatment response markers. An analysis of the effects on cortical activity and plasticity markers could be an interesting approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Neuroconn or Neuroelectric tDCS stimulatorStimulation will be performed using an tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl). The anode will be placed with the middle of the electrode over a point midway between F3 and FP1 (left prefrontal cortex: dorsolateral prefrontal cortex, assumed to correspond to a region including Brodmann's Areas (BA) 8, 9, 10, and 46, depending on the patient). The cathode will be located over a point midway between T3 and P3 (left temporo-parietal junction, assumed to correspond to a region including BA 22, 39, 40, 41, and 42, depending on the patient). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day for 5 consecutive weekdays. The twice daily sessions will be separated by at least 2 hours. |
| Sham tDCS | Sham comparator | Device: Sham tDCS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of schizophrenia according to DSM 5.0 (Diagnostic and Statistical Manuel 5.0) criteria
- Presence of symptoms despite the optimization of the antipsychotic dosage (based on prescriber's judgment) for at least 6 weeks, i.e. a dosage increase cannot be considered due to tolerability issues and/or is judged unlikely to bring sufficient clinical improvement. This will be operationalized by a minimum Negative PANSS score of 20 and at least one item scoring > 4; OR a minimum Positive PANSS score of 20 with at least one item scoring > 4 (e.g. delusion or hallucination), indicating persistent negative symptoms and/or persistent positive symptoms,
- Patient under curatorship/guardianship or not
- Age between 18 and 65 years old.
- Covered by, or having the right to Social Security
Key exclusion criteria (5 listed)
- Other neuropsychiatric disorders (psychiatric history will be assessed using the MINI 6.0 (Mini International Neuropsychiatric Interview 6.0)) including bipolar disorders and mood depression disorders - (NB: Patients with substance related and addictive disorders will not be excluded from the study, but these data will be carefully recorded).
- Contraindications for tDCS (neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes),
- Increase in total composite PANSS score of at least 20% between screening and enrollment visits
- Women who are pregnant
- Patients whose clinical condition requires in patient procedure under constraint
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 |
|---|---|---|
| Neuroconn or Neuroelectric tDCS stimulatorStimulation parameters were chosen in conformity with those for the treatment of schizophrenic symptoms (Brunelin et al, 2012), adapted according to the latest data from the literature and the tDCS operating stimulator. The experimental tDCS group will receive the ACTIVE stimulation with the following parameters: oscillatory Direct Current with high frequency random noise stimulation (hf-tRNS - 100 to 500 Hz), Intensity = 2 mA, offset = + 1 mA, seance duration = 20 minutes ramp up/ramp down 30 seconds. Total number of sessions = 10 (sessions twice daily for 5 days separated by at least 2 hours for 5 consecutive weekdays). | Device | Active tDCS |
| Sham tDCSThe control group will receive the SHAM stimulation (placebo) following the same regimen (i.e., twice daily sessions separated by at least 2 hours for 5 consecutive weekdays). Sham stimulation consists of a 20 minutes session including 40 seconds of active stimulation (same parameters as in the ACTIVE arm) at the beginning of the sessions, whatever the stimulator | Device | Sham tDCS |
Primary outcome
Number of responders
Time frame: Between baseline (day 0) and after 10-sessions of tDCS regimen (day 5)
The number of responders is based on the Positive and Negative Syndrome Scale (PANSS) score in the active and the sham group after 5 days of tDCS. According to Leucht et al (2009), response is defined as a decrease of at least 25% in the Positive and Negative Syndrome Scale (PANSS, Kay et al., 1987) score after the intervention.
16 secondary outcomes
Positive and Negative Syndrome Scale (PANSS) score
Time frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Auditory Hallucination Rating Scale (AHRS) score
Time frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Psycho-Sensory hAllucinations Scale (PSAS) score
Time frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Calgary Depression Scale for Schizophrenia (CDSS) score
Time frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Clinical Global Impression (CGI) score
Time frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session
Shortened Quality of Life questionnaire score
Time frame: Baseline and 6 months after the last tDCS session
Scale to assess Unawareness of Mental Disorder (SUMD) score
Time frame: Baseline and 3 months after the last tDCS session
Medication Adherence rating Scale (MARS) score
Time frame: Baseline and 3 months after the last tDCS session
Brief Medication Questionnaire (BMQ) scores
Time frame: Baseline and 3 months after the last tDCS session
Source monitoring test score
Time frame: Baseline and day 5 (after 10-sessions of tDCS regimen)
Functional magnetic resonance imaging (MRI)
Time frame: Baseline, day 5 (after 10-sessions of tDCS regimen) and 1 month after the last tDCS session
Anatomical magnetic resonance imaging (MRI)
Time frame: Baseline, day 5 (after 10-sessions of tDCS regimen) and 1 month after the last tDCS session
Total serum Brain-Derived-Neurotrophic Factor (BDNF)
Time frame: Baseline
Serum Brain-Derived-Neurotrophic Factor (BDNF) isoforms
Time frame: Baseline
Self-evaluation of Negative Symptoms (SNS) score
Time frame: Baseline, 1 month and 3 months after the last tDCS session
Fargerström test score
Time frame: Baseline, 1 month and 6 months after the last tDCS session
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 19 Dec 2025.
- Results publication: PubMed 34963486Brunelin J, Mondino M, Haesebaert J, Attal J, Benoit M, Chupin M, Dollfus S, El-Hage W, Galvao F, Jardri R, Llorca PM, Magaud L, Plaze M, Schott-Pethelaz AM, Suaud-Chagny MF, Szekely D, Fakra E, Poulet E. Examining transcranial random noise stimulation as an add-on treatment for persistent symptoms in schizophrenia (STIM'Zo): a study protocol for a multicentre, double-blind, randomized sham-controlled clinical trial. Trials. 2021 Dec 28;22(1):964. doi: 10.1186/s13063-021-05928-9.
Related trials for Mental Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroconn or Neuroelectric tDCS stimulator in people with Mental Disorders and Schizophrenia, run by Hospices Civils de Lyon at 10 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 7 inclusion and 5 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Monaco. 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?
Number of responders (time frame: Between baseline (day 0) and after 10-sessions of tDCS regimen (day 5)). 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 NCT02744989, 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 19 Dec 2025.