Schizophreniform CatatoniaRETONICNCT03116425
Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia
A study testing Individualized rTMS on VERUM 1's region or network and Individualized rTMS on VERUM 2's region or network in people with Schizophreniform Catatonia and Treatment Resistant, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to improve symptoms of patients suffering from chronic catatonia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophreniform Catatonia, Treatment Resistant
- What is being tested?
- Individualized rTMS on VERUM 1's region or network and Individualized rTMS on VERUM 2's region or network
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2017to Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 70 Y
- Affiliated to the health insurance
- Having signed an informed consent
- Suffering from catatonia according to the DSM5, unremitted since > 2Y
- Unresponsive or incomplete remission after at least one trial of benzodiazepine and/or Electroconvulsivotherapy
- Treatment stable for > 6 weeks
Who cannot join
- Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
- Pregnancy
- Severe and non-stabilized somatic pathology
- Patients deprived of liberty or hospitalized without their consent
- Patients unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia - A Proof of Concept Study
Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to improve symptoms of patients suffering from chronic catatonia.
Read the detailed description
Two dysfunctional networks or regions will be chosen (verum 1 and 2) based on their abnormal rCBF. In line with the symptoms, dorso-lateral prefrontal and premotor regions are expected to be chiefly concerned. A normal region regarding its rCBF will be used as placebo. Targets will be stimulated using intermittent or continuous theta-burst according to the rCBF anomaly as an attempt to "normalize" their activity. The coil will be positioned using a robotic device under the control of a neuronavigation system in order to deliver a homogeneous stimulation. Using a balanced blinded randomized cross-over design, patients will be stimulated on 5 consecutive days (4 sessions per day) and evaluated pre-, post-stimulation and 1 month after. In this pilot study the primary outcome measures will be the clinical global impression scale whereas MRI will insure that stimulations achieved the correction of the rCBF anomalies. Secondary outcome measures will include personalized target symptom scales, and scales for catatonic, apathic and obsessive-compulsive symptoms.
- Conditions
- Schizophreniform Catatonia, Treatment Resistant
- Being tested
- Individualized rTMS on VERUM 1's region or network, Individualized rTMS on VERUM 2's region or network, Individualized rTMS on PLACEBO region
- Keywords
- Precision Medicine, Functional Neuroimaging, Transcranial Magnetic Stimulation, Repetitive, Transcranial Direct Current Stimulation, Monocentric, Comparative balanced, randomized, double-blind cross-over 3 Arms Study
- Medical subject headings
- Catatonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized rTMS on VERUM 1's region or networkDevice
Also called Putative premotor region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on VERUM 2's region or networkDevice
Also called Putative prefrontal region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on PLACEBO regionDevice
Also called (One per line)
Region will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions.
Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on VERUM 1's region or networkProcedure or surgery
Also called Putative premotor region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on VERUM 2's region or networkProcedure or surgery
Also called Putative prefrontal region or network
To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
Patients will have 4 sessions per day on 5 successive days per arm.
Individualized rTMS on PLACEBO regionProcedure or surgery
Region will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions.
Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm.
| Study group | Role | What they receive |
|---|---|---|
| Verum 1 - Premotor | Experimental | The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 38). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio.
The network including the premotor region will be targeted. The therapeutic protocol will be design to correct the rCBF anomaly. Receives: Device: Individualized rTMS on VERUM 1's region or network; Procedure: Individualized rTMS on VERUM 1's region or network |
| Verum 2 - Prefrontal | Experimental | The target region will be defined by comparing the rCBF scan of the patient to a control population (n = 38). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio.
The network including the prefrontal region will be targeted. The therapeutic protocol will be design to correct the rCBF anomaly. Receives: Device: Individualized rTMS on VERUM 2's region or network; Procedure: Individualized rTMS on VERUM 2's region or network |
| Placebo | Active comparator | Stimulation of a region with normal rCBF and putatively unrelated to catatonic symptoms (parietal cortex). Receives: Device: Individualized rTMS on PLACEBO region; Procedure: Individualized rTMS on PLACEBO region |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical global impression (change in severity and improvement)
Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention
Measured: In term of percentage reduction in symptoms, difference between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Secondary outcomes (11)
Change in personalized daily visual analogical scales assessing the core symptoms.
This scale has been validated
Measured: Points results will be averaged over the 4 days before and after each therapeutic arm.
Change in Bush and Francis Catatonia Rating Scale.
This scale has been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in psychosis: PANSS.
This scale has been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in depression: Calgary Depression Scale.
This scale has been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in apathy: actimetry, apathy inventory and apathy evaluation scale.
This scale has been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in obsessive compulsive symptoms: Brief Obsessive Compulsive Scale
This scale has been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in obsessive compulsive symptoms: Cambridge-Exeter Repetitive Thought Scale.
This scale has been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in quality of life for the patient (SF36)
All these scales have been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in the helping person ("Zarit scale")
This scale has been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in functioning: Global Assessment of Functioning (GAF scale)
This scale has been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in functioning: WHODAS 2.0.
This scale has been validated.
Measured: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start24 Apr 2017
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophreniform CatatoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack FOUCHER, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116425
- Sponsor's protocol ID
- 6441
- Acronym
- RETONIC
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2017
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia - A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT03116425
- Acronym / sponsor ID
- RETONIC / 6441
- Conditions
- Schizophreniform Catatonia, Treatment Resistant
- Keywords
- Precision Medicine, Functional Neuroimaging, Transcranial Magnetic Stimulation, Repetitive, Transcranial Direct Current Stimulation, Monocentric, Comparative balanced, randomized, double-blind cross-over 3 Arms Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 17 Apr 2017 (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.
Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to improve symptoms of patients suffering from chronic catatonia.
Detailed description
Two dysfunctional networks or regions will be chosen (verum 1 and 2) based on their abnormal rCBF. In line with the symptoms, dorso-lateral prefrontal and premotor regions are expected to be chiefly concerned. A normal region regarding its rCBF will be used as placebo. Targets will be stimulated using intermittent or continuous theta-burst according to the rCBF anomaly as an attempt to "normalize" their activity. The coil will be positioned using a robotic device under the control of a neuronavigation system in order to deliver a homogeneous stimulation. Using a balanced blinded randomized cross-over design, patients will be stimulated on 5 consecutive days (4 sessions per day) and evaluated pre-, post-stimulation and 1 month after. In this pilot study the primary outcome measures will be the clinical global impression scale whereas MRI will insure that stimulations achieved the correction of the rCBF anomalies. Secondary outcome measures will include personalized target symptom scales, and scales for catatonic, apathic and obsessive-compulsive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verum 1 - Premotor | Experimental | Device: Individualized rTMS on VERUM 1's region or network, Procedure: Individualized rTMS on VERUM 1's region or networkThe target region will be defined by comparing the rCBF scan of the patient to a control population (n = 38). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. The network including the premotor region will be targeted. The therapeutic protocol will be design to correct the rCBF anomaly. |
| Verum 2 - Prefrontal | Experimental | Device: Individualized rTMS on VERUM 2's region or network, Procedure: Individualized rTMS on VERUM 2's region or networkThe target region will be defined by comparing the rCBF scan of the patient to a control population (n = 38). rCBF will be measured using the QUIPS2 arterial spin labeling sequence on a Siemens 3T Verio. The network including the prefrontal region will be targeted. The therapeutic protocol will be design to correct the rCBF anomaly. |
| Placebo | Active comparator | Device: Individualized rTMS on PLACEBO region, Procedure: Individualized rTMS on PLACEBO regionStimulation of a region with normal rCBF and putatively unrelated to catatonic symptoms (parietal cortex). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged from 18 to 70 Y
- Affiliated to the health insurance
- Having signed an informed consent
- Suffering from catatonia according to the DSM5, unremitted since > 2Y
- Unresponsive or incomplete remission after at least one trial of benzodiazepine and/or Electroconvulsivotherapy
Key exclusion criteria (5 listed)
- Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
- Pregnancy
- Severe and non-stabilized somatic pathology
- Patients deprived of liberty or hospitalized without their consent
- Patients unable to give informed 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 |
|---|---|---|
| Individualized rTMS on VERUM 1's region or networkAlso: Putative premotor region or networkTo increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec. To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold). Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage. Patients will have 4 sessions per day on 5 successive days per arm. | Device | Verum 1 - Premotor |
| Individualized rTMS on VERUM 2's region or networkAlso: Putative prefrontal region or networkTo increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec. To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold). Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage. Patients will have 4 sessions per day on 5 successive days per arm. | Device | Verum 2 - Prefrontal |
| Individualized rTMS on PLACEBO regionAlso: (One per line)Region will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions. Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm. | Device | Placebo |
| Individualized rTMS on VERUM 1's region or networkAlso: Putative premotor region or networkTo increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec. To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold). Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage. Patients will have 4 sessions per day on 5 successive days per arm. | Procedure or surgery | Verum 1 - Premotor |
| Individualized rTMS on VERUM 2's region or networkAlso: Putative prefrontal region or networkTo increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec. To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold). Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage. Patients will have 4 sessions per day on 5 successive days per arm. | Procedure or surgery | Verum 2 - Prefrontal |
| Individualized rTMS on PLACEBO regionRegion will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions. Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm. | Procedure or surgery | Placebo |
Primary outcome
Clinical global impression (change in severity and improvement)
Time frame: In term of percentage reduction in symptoms, difference between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention
11 secondary outcomes
Change in personalized daily visual analogical scales assessing the core symptoms.
Time frame: Points results will be averaged over the 4 days before and after each therapeutic arm.
Change in Bush and Francis Catatonia Rating Scale.
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in psychosis: PANSS.
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in depression: Calgary Depression Scale.
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in apathy: actimetry, apathy inventory and apathy evaluation scale.
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in obsessive compulsive symptoms: Brief Obsessive Compulsive Scale
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in obsessive compulsive symptoms: Cambridge-Exeter Repetitive Thought Scale.
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in quality of life for the patient (SF36)
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in the helping person ("Zarit scale")
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in functioning: Global Assessment of Functioning (GAF scale)
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Change in functioning: WHODAS 2.0.
Time frame: Points involvement in scale between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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.
Jack FOUCHER, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized rTMS on VERUM 1's region or network and Individualized rTMS on VERUM 2's region or network in people with Schizophreniform Catatonia and Treatment Resistant, run by University Hospital, Strasbourg, 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 6 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical global impression (change in severity and improvement) (time frame: In term of percentage reduction in symptoms, difference between before (assessed on D1) and after (assessed on D5 to 7) and at 1 month after each therapeutic protocol (D = day of the beginning of the protocol)). 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 20 Apr 2022.