SchizophreniaSTICOGNCT05440955
tDCS for Cognitive Impairment Associated With Recent-onset Schizophrenia
A study testing left fronto-temporal transcranial Direct Current Stimulation (tDCS) in people with Schizophrenia and Psychotic Disorder, run by University Hospital, Grenoble at 4 sites in France.
Trial summary
Background: In parallel to the traditional symptomatology, deficits in cognition (memory, attention, reasoning, social functioning) contribute significantly to disability and suffering in individuals with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorder
- What is being tested?
- left fronto-temporal transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jun 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- No healthy volunteers
- Adult
The inclusion criteria include:
- subjects of both genders, diagnosed with recent-onset schizophrenia (first 3 years of illness), confirmed through the Structured Clinical Interview for the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition (SCID-5);
- aged 18-35 years;
- intelligence quotient (IQ) > 55;
- cognitive deficit confirmed by a MCCB (MATRICS Cognitive Consensus Battery) total score T-score < 40;
- the subjects should be receiving stable doses of antipsychotics for ≥ 4 weeks;
- the subjects are covered by a public health insurance.
The exclusion criteria include:
- pregnant (controlled by urine pregnancy test in females of childbearing age) or breastfeeding women;
- unstable or acute medical conditions;
- subjects who receive involuntary treatment or guardianship;
- history of cranioencephalic trauma with loss of consciousness or central nervous system diseases that affect the brain;
- use of drugs that affect cognitive performance such as anticholinergic agents and benzodiazepines;
- current diagnosis of substance abuse or history of substance dependence in the last 6 months, except nicotine;
- MRI (Magnetic Resonance Imaging), PET (Positron Emission Tomography) or tDCS (transcranial Direct Current Stimulation) contraindications
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
CH Le Vinatier
Bron, 69500
Lydie Sartelet, lydie.sartelet@ch-le-vinatier.fr
Filipe GALVAO, MD
CHU Grenoble Alpes
La Tronche, Auvergne-Rhône-Alpes, 38700
Colombat Julien, 04 76 76 56 09, jcolombat@chu-grenoble.fr
Clément DONDÉ, MD PhD
CH Alpes-Isère
Saint-Égrève, Auvergne-Rhône-Alpes, 38120
Julien COLOMBAT, 04 76 76 56 09, jcolombat@chu-grenoble.fr
Clément DONDÉ, MD PhD
CHU Saint-Etienne
Saint-Etienne, 42055
Hélène RINGARD, 04.77.82.97.03, helene.raingard@chu-st-etienne.fr
Eric FAKRA, MD PhD
About this study
Official title: Efficacy and Auditory Biomarker Analysis of Fronto-Temporal Transcranial Direct Current Stimulation (tDCS) in Targeting Cognitive Impairment Associated With Recent-onset Schizophrenia: A Randomized Double-blind Sham-controlled Trial
Background: In parallel to the traditional symptomatology, deficits in cognition (memory, attention, reasoning, social functioning) contribute significantly to disability and suffering in individuals with schizophrenia. Cognitive deficits have been closely linked to alterations in early auditory processes (EAP) that occur in auditory cortical areas. Preliminary evidence indicates that cognitive deficits in schizophrenia can be improved with a reliable and safe non-invasive brain stimulation technique called tDCS (transcranial Direct Current Stimulation). However, a significant proportion of patients derive no cognitive benefits after tDCS treatment. Further, the neurobiological mechanisms of cognitive changes after tDCS have been poorly explored in trials and are thus still unclear.
Method: The study is designed as a randomized, double-blind, 2-arm parallel-group, sham controlled, 4-centers trial. Sixty participants with recent-onset schizophrenia and cognitive impairment will be randomly allocated to receive either active (n=30) or sham (n=30) tDCS (20-min, 2-mA, 10 sessions during 5 consecutive weekdays). The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left auditory cortex. Cognition, tolerance, symptoms, general outcome and EAP (measured with EEG and multimodal MRI) will be assessed prior to tDCS (baseline), after the 10 sessions, and at 1- and 3-month follow-up. The primary outcome will be the number of responders, defined as participants demonstrating a cognitive improvement ≥Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score at 1-month follow-up. Additionally, we will measure how differences in EAP modulate individual cognitive benefits from active tDCS and whether there are changes in EAP measures in responders after active tDCS.
Discussion: Besides proposing a new fronto-temporal tDCS protocol by targeting the auditory cortical areas, we aim to conduct an RCT with follow-up assessments up to 3-months and a large sample size. In addition, this study will allow identifying and assessing the value of a wide range of neurobiological EAP measures for predicting and explaining cognitive deficits improvement after tDCS. The results of this trial will constitute a step toward the use of tDCS as a therapeutic tool for the treatment of cognitive impairment in recent-onset schizophrenia.
- Conditions
- Schizophrenia, Psychotic Disorder
- Being tested
- left fronto-temporal transcranial Direct Current Stimulation (tDCS)
- Keywords
- schizophrenia, cognitive impairment, tDCS, early auditory processing, clinical trial
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left fronto-temporal transcranial Direct Current Stimulation (tDCS)Device
The study intervention consists of ten 20-minutes sessions of active or sham tDCS. Sessions will be delivered twice daily and separated by at least 2 hours for 5 consecutive weekdays. The electric current will be generated by an electric stimulator (class IIa medical device). During the entire tDCS session, the subject is at "rest", comfortably seated in a chair in a quiet room. A clinician will be present for the entire session duration. The current will be applied via a pair of rubber electrodes (35 cm²) placed on the surface of the scalp. The anode will be placed over the left dorsolateral prefrontal cortex. The cathode will be placed over the left auditory cortex. The stimulation parameters will be set at 2-mA for 20 minutes, with a progressive increase during the first 30-sec and a progressive decrease during the last 30-sec of each session. The impedance of the applied current is monitored by the stimulator during each session.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Experimental | tDCS (transcranial Direct Current Stimulation subjects) is a noninvasive brain stimulation technique that involves the passage of a small electric current through the scalp and skull to modulate brain activity [10]. The study intervention consists of ten 20-minutes sessions of active or sham tDCS. Sessions will be delivered twice daily and separated by at least 2 hours for 5 consecutive weekdays. The electric current will be generated by an electric stimulator (class IIa medical device). Receives: Device: left fronto-temporal transcranial Direct Current Stimulation (tDCS) |
| sham tDCS | Sham comparator | The sham procedure is developed by the tDCS device manufacturer, which allows using the same tDCS device and the same procedure (i.e., 10 sessions delivered during five consecutive days) for both the active and sham procedures. In the sham condition, the electrodes will be placed in the same positions as in the active group; however, the stimulator will be only active for initial and final ramp up/ramp down periods, in order to mimic the sensation of active stimulation. In addition, brief pulses of 110 μA will be administered every 550 ms in order to control impedance and keep the manipulator blinded to the active or sham condition. Receives: Device: left fronto-temporal transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive response
Number of responders at 1-month after tDCS, defined as the proportion of patients demonstrating a cognitive improvement greater than or equal to Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score (MCCB). The MCCB is a gold-standard standardized test battery to assess cognitive functions in patients with schizophrenia. This criterion has been used and validated in both antipsychotic and cognitive remediation trials in schizophrenia.
Measured: at 1-month follow-up
Secondary outcomes (24)
Long term cognitive response
Number of responders at 3-months after tDCS, defined as the proportion of patients demonstrating a cognitive improvement greater than or equal to Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score (MCCB). The MCCB is a gold-standard standardized test battery to assess cognitive functions in patients with schizophrenia. This criterion has been used and validated in both antipsychotic and cognitive remediation trials in schizophrenia.
Measured: at inclusion; at 3-months follow-up
Cognitive domain response
Changes from baseline to 1-month and 3-months endpoints in each MCCB domains subscores (processing speed, attention/vigilance, working memory, verbal learning, visual learning, problem solving, emotional awareness) and total score.
Measured: at inclusion; at 1-month follow-up; at 3-months follow-up
Clinical response 1
Changes from baseline to after tDCS, 1-month and 3-months endpoints in the following symptom measure:
- Schizophrenia symptoms will be assessed using the PANSS (Positive and Negative Syndrome Scale) total score.
Measured: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 2
Changes from baseline to after tDCS, 1-month and 3-months endpoints in the following symptom measure:
- Auditory hallucinations, one of the key symptoms of schizophrenia, will be assessed using the AHRS (Auditory Hallucination Rating Scale)
Measured: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 3
Changes from baseline to after tDCS, 1-month and 3-months endpoints in the following symptom measure:
- Negative symptoms will be additionally assessed using the Brief Negative Symptom Scale (BNSS).
Measured: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 4
Changes from baseline to after tDCS, 1-month and 3-months endpoints in the following symptom measure:
- Depressive symptoms will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS) total score.
Measured: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 5
Changes from baseline to after tDCS, 1-month and 3-months endpoints in the following symptom measure:
- Global symptom severity and treatment response will be assessed using the Clinical Global Impressions Scale (CGI) total score.
Measured: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 6
Changes from baseline to after tDCS, 1-month and 3-months endpoints in the following symptom measure:
- Subjective experience of negative symptoms will be assessed using the Self-evaluation of Negative Symptoms (SNS) total score
Measured: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 7
Changes from baseline to after tDCS, 1-month and 3-months endpoints in the following symptom measure:
- Subjective experiences of cognitive impairment will be assessed using the self-rated Subjective Scale To Investigate Cognition in Schizophrenia (SSTICS) total score.
Measured: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Outcome response 1
Changes from baseline to 1-month and 3-months endpoints in the following general outcome measures:
- Functional outcome will be assessed using the FROGS (Functional Remission Observatory Group in Schizophrenia) total score
Measured: at inclusion; at 1-month follow-up; at 3-months follow-up
Outcome response 2
Changes from baseline to 1-month and 3-months endpoints in the following general outcome measures:
- Quality of life will be assessed by the Schizophrenia Quality of Life Questionnaire Short Form (S-QoL 18) total score
Measured: at inclusion; at 1-month follow-up; at 3-months follow-up
Tolerance 1
Score after the last tDCS session in the following tolerance measure:
- tDCS-AEQ (Adverse Effects Questionnaire)
Measured: at 1-week
Tolerance 2
Score after the last tDCS session in the following tolerance measure:
- VAMS (Visual Analogue Mood Scale)
Measured: at 1-week
Response marker 1
The differences at baseline in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- correlations (z-scores) between left prefrontal and temporal cortical areas (i.e., areas stimulated with tDCS) measured with resting-state functional Magnetic Resonance Imaging (MRI).
Measured: at inclusion
Response marker 2
The differences at baseline in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- spectral power (dB) in gamma frequency (40-Hz) during specific auditory paradigms (auditory steady-state, oddball, tone-matching) measured with electroencephalography (EEG).
Measured: at inclusion
Response marker 3
The differences at baseline in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- inter-assay coherence (%) in gamma frequency (40-Hz) during specific auditory paradigms (auditory steady-state, oddball, tone-matching) measured with electroencephalography (EEG).
Measured: at inclusion
Response marker 4
The differences at baseline in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- GABA and Glutamate levels (mM) within left prefrontal and temporal cortical areas measured with resting-state Magnetic Resonance Spectroscopy (MRS)
Measured: at inclusion
Response marker 5
The differences at baseline in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- radiotracer binding potential on GABA-A receptors (Binding Potential) within left prefrontal and temporal cortical areas measured with resting-state [11C]flumazenil Positron Emission Tomography MRI (PET-MRI).
Measured: at inclusion
Response predictor 1
Changes from baseline to 1-month in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- correlations (z-scores) between left prefrontal and temporal cortical areas (i.e., areas stimulated with tDCS) measured with resting-state functional Magnetic Resonance Imaging (MRI).
Measured: at inclusion; at 1-month follow-up
Response predictor 2
Changes from baseline to 1-month in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- spectral power (dB) in gamma frequency (40-Hz) during specific auditory paradigms (auditory steady-state, oddball, tone-matching) measured with electroencephalography (EEG).
Measured: at inclusion; at 1-month follow-up
Response predictor 3
Changes from baseline to 1-month in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- inter-assay coherence (%) in gamma frequency (40-Hz) during specific auditory paradigms (auditory steady-state, oddball, tone-matching) measured with electroencephalography (EEG).
Measured: at inclusion; at 1-month follow-up
Response predictor 4
Changes from baseline to 1-month in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- GABA and Glutamate levels (mM) within left prefrontal and temporal cortical areas measured with resting-state Magnetic Resonance Spectroscopy (MRS)
Measured: at inclusion; at 1-month follow-up
Response predictor 5
Changes from baseline to 1-month in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- GABA and Glutamate levels (mM) within left prefrontal and temporal cortical areas measured with resting-state Magnetic Resonance Spectroscopy (MRS)
Measured: at inclusion; at 1-month follow-up
Response predictor 6
Changes from baseline 1-month in the following early auditory processing (EAP) measure between patients with cognitive improvement and patients without cognitive improvement after active tDCS:
- radiotracer binding potential on GABA-A receptors (Binding Potential) within left prefrontal and temporal cortical areas measured with resting-state [11C]flumazenil Positron Emission Tomography MRI (PET-MRI).
Measured: at inclusion; at 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
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 University Hospital, GrenobleThe 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
- Model description
- The present study is designed as a superiority, double-blind, parallel-group, sham-controlled randomized clinical trial with an allocation ratio of 1:1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Clément DONDÉ, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440955
- Sponsor's protocol ID
- STICOG
- Acronym
- STICOG
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available from the principal investigator to other study investigators or scientists upon reasonable request.
Publications
Donde C, Bastin J, Pouchon A, Costes N, Fakra E, Galvao F, Gay A, Haesebaert F, Lamalle L, Merida I, Rigon M, Schneider F, Tropres I, Brunelin J, Polosan M. Efficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in targeting cognitive impairment associated with recent-onset schizophrenia: study protocol for a multicenter randomized double-blind sham-controlled trial. Trials. 2023 Feb 24;24(1):141. doi: 10.1186/s13063-023-07160-z.
PubMed 36829240
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Auditory Biomarker Analysis of Fronto-Temporal Transcranial Direct Current Stimulation (tDCS) in Targeting Cognitive Impairment Associated With Recent-onset Schizophrenia: A Randomized Double-blind Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05440955
- Acronym / sponsor ID
- STICOG / STICOG
- Conditions
- Schizophrenia, Psychotic Disorder
- Keywords
- schizophrenia, cognitive impairment, tDCS, early auditory processing, clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 Jul 2022 (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.
Background: In parallel to the traditional symptomatology, deficits in cognition (memory, attention, reasoning, social functioning) contribute significantly to disability and suffering in individuals with schizophrenia. Cognitive deficits have been closely linked to alterations in early auditory processes (EAP) that occur in auditory cortical areas. Preliminary evidence indicates that cognitive deficits in schizophrenia can be improved with a reliable and safe non-invasive brain stimulation technique called tDCS (transcranial Direct Current Stimulation). However, a significant proportion of patients derive no cognitive benefits after tDCS treatment. Further, the neurobiological mechanisms of cognitive changes after tDCS have been poorly explored in trials and are thus still unclear.
Method: The study is designed as a randomized, double-blind, 2-arm parallel-group, sham controlled, 4-centers trial. Sixty participants with recent-onset schizophrenia and cognitive impairment will be randomly allocated to receive either active (n=30) or sham (n=30) tDCS (20-min, 2-mA, 10 sessions during 5 consecutive weekdays). The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left auditory cortex. Cognition, tolerance, symptoms, general outcome and EAP (measured with EEG and multimodal MRI) will be assessed prior to tDCS (baseline), after the 10 sessions, and at 1- and 3-month follow-up. The primary outcome will be the number of responders, defined as participants demonstrating a cognitive improvement ≥Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score at 1-month follow-up. Additionally, we will measure how differences in EAP modulate individual cognitive benefits from active tDCS and whether there are changes in EAP measures in responders after active tDCS.
Discussion: Besides proposing a new fronto-temporal tDCS protocol by targeting the auditory cortical areas, we aim to conduct an RCT with follow-up assessments up to 3-months and a large sample size. In addition, this study will allow identifying and assessing the value of a wide range of neurobiological EAP measures for predicting and explaining cognitive deficits improvement after tDCS. The results of this trial will constitute a step toward the use of tDCS as a therapeutic tool for the treatment of cognitive impairment in recent-onset schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study is designed as a superiority, double-blind, parallel-group, sham-controlled randomized clinical trial with an allocation ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Experimental | Device: left fronto-temporal transcranial Direct Current Stimulation (tDCS)tDCS (transcranial Direct Current Stimulation subjects) is a noninvasive brain stimulation technique that involves the passage of a small electric current through the scalp and skull to modulate brain activity [10]. The study intervention consists of ten 20-minutes sessions of active or sham tDCS. Sessions will be delivered twice daily and separated by at least 2 hours for 5 consecutive weekdays. The electric current will be generated by an electric stimulator (class IIa medical device). |
| sham tDCS | Sham comparator | Device: left fronto-temporal transcranial Direct Current Stimulation (tDCS)The sham procedure is developed by the tDCS device manufacturer, which allows using the same tDCS device and the same procedure (i.e., 10 sessions delivered during five consecutive days) for both the active and sham procedures. In the sham condition, the electrodes will be placed in the same positions as in the active group; however, the stimulator will be only active for initial and final ramp up/ramp down periods, in order to mimic the sensation of active stimulation. In addition, brief pulses of 110 μA will be administered every 550 ms in order to control impedance and keep the manipulator blinded to the active or sham condition. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| left fronto-temporal transcranial Direct Current Stimulation (tDCS)The study intervention consists of ten 20-minutes sessions of active or sham tDCS. Sessions will be delivered twice daily and separated by at least 2 hours for 5 consecutive weekdays. The electric current will be generated by an electric stimulator (class IIa medical device). During the entire tDCS session, the subject is at "rest", comfortably seated in a chair in a quiet room. A clinician will be present for the entire session duration. The current will be applied via a pair of rubber electrodes (35 cm²) placed on the surface of the scalp. The anode will be placed over the left dorsolateral prefrontal cortex. The cathode will be placed over the left auditory cortex. The stimulation parameters will be set at 2-mA for 20 minutes, with a progressive increase during the first 30-sec and a progressive decrease during the last 30-sec of each session. The impedance of the applied current is monitored by the stimulator during each session. | Device | active tDCS, sham tDCS |
Primary outcome
Cognitive response
Time frame: at 1-month follow-up
Number of responders at 1-month after tDCS, defined as the proportion of patients demonstrating a cognitive improvement greater than or equal to Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score (MCCB). The MCCB is a gold-standard standardized test battery to assess cognitive functions in patients with schizophrenia. This criterion has been used and validated in both antipsychotic and cognitive remediation trials in schizophrenia.
24 secondary outcomes
Long term cognitive response
Time frame: at inclusion; at 3-months follow-up
Cognitive domain response
Time frame: at inclusion; at 1-month follow-up; at 3-months follow-up
Clinical response 1
Time frame: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 2
Time frame: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 3
Time frame: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 4
Time frame: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 5
Time frame: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 6
Time frame: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Clinical response 7
Time frame: at inclusion; at 1-week; at 1-month follow-up; at 3-months follow-up
Outcome response 1
Time frame: at inclusion; at 1-month follow-up; at 3-months follow-up
Outcome response 2
Time frame: at inclusion; at 1-month follow-up; at 3-months follow-up
Tolerance 1
Time frame: at 1-week
Tolerance 2
Time frame: at 1-week
Response marker 1
Time frame: at inclusion
Response marker 2
Time frame: at inclusion
Response marker 3
Time frame: at inclusion
Response marker 4
Time frame: at inclusion
Response marker 5
Time frame: at inclusion
Response predictor 1
Time frame: at inclusion; at 1-month follow-up
Response predictor 2
Time frame: at inclusion; at 1-month follow-up
Response predictor 3
Time frame: at inclusion; at 1-month follow-up
Response predictor 4
Time frame: at inclusion; at 1-month follow-up
Response predictor 5
Time frame: at inclusion; at 1-month follow-up
Response predictor 6
Time frame: at inclusion; at 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 36829240Donde C, Bastin J, Pouchon A, Costes N, Fakra E, Galvao F, Gay A, Haesebaert F, Lamalle L, Merida I, Rigon M, Schneider F, Tropres I, Brunelin J, Polosan M. Efficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in targeting cognitive impairment associated with recent-onset schizophrenia: study protocol for a multicenter randomized double-blind sham-controlled trial. Trials. 2023 Feb 24;24(1):141. doi: 10.1186/s13063-023-07160-z.
- Individual participant dataSharing planned: Yes. The data will be available from the principal investigator to other study investigators or scientists upon reasonable request.
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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.
Clément DONDÉ principal investigator
CHU Grenoble Alpes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left fronto-temporal transcranial Direct Current Stimulation (tDCS) in people with Schizophrenia and Psychotic Disorder, run by University Hospital, Grenoble at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien COLOMBAT (04 76 76 56 09, jcolombat@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive response (time frame: at 1-month follow-up). 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 NCT05440955, 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 4 Apr 2023.