Parkinson DiseaseAideAlimParkNCT05898139
Describe to Better Understand, the Mealtime of People With Parkinson's Disease Dependent on Food Intake
An observational study of Parkinson Disease and Deglutition Disorders, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The main objective is to describe strategies (verbal, non-verbal (gesture, intonation), and environmental), designed and used by the assisting/aided dyad to feed a dysphagic dependent person by articulating the safe and hedonic dimensions in the context of Parkinson's disease or atypical parkinsonian syndrome during a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Deglutition Disorders
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2024to 13 Oct 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with typical or atypical parkinsonian syndrome and their caregiver
Who may be able to join
- Patient with typical or atypical Parkinsonian syndrome, collected in the medical record
- Indication of swallowing disorders or dysphagia, according to item 2.3 chewing and swallowing, part II of the MSD/UPDRS scale or collection in the medical record
- Person dependent on food (according to MDS/UPDRS - food tasks item, part II, 2.4 ≥ 2, to be help to cut food punctually
- Having a usual caregiver present for the meal.
- Affiliated person or beneficiary of a social security scheme.
- Free, informed, written and signed consent by participant and investigator (no later than the day of inclusion and prior to any review required by the research)
- caregiver of the patient for at least 2 months for the taking of meal
- Person with French language to answer the questions of the interview
Who cannot join
- Individuals whose cognitive state does not allow simple questions to be answered, as judged by the neurologist
- Person fed exclusively by enteral nutrition.
- Patient who refuses to be filmed
- For caregivers:
- Patient who refuses to be filmed
- Protected patient: under guardianship, trusteeship or other legal protection, deprived of freedom by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital, Parkinson center
Toulouse, Haute-Garonne, 31059
About this study
The main objective is to describe strategies (verbal, non-verbal (gesture, intonation), and environmental), designed and used by the assisting/aided dyad to feed a dysphagic dependent person by articulating the safe and hedonic dimensions in the context of Parkinson's disease or atypical parkinsonian syndrome during a meal
Read the detailed description
It is described in the literature that being helped for the meal disrupts the pre-oral phase in the visual and proprioceptive afferences received by the sick person to prepare neurologically the other phases of swallowing. In cases of dysphagia, regardless of the cause, the need for food assistance is correlated with higher mortality and an increased risk of pneumonia. Thus, whether at home or in an establishment, human help is often put in place to facilitate the time of the meal, make it more effective (limitation of the duration of the meal, maximization of the nutritional amounts ingested) and safe (prevention of the occurrence of wrong driving). Our hypothesis is that representations about food and aid at meal times, as well as the attitudes of both the helper and the helped, are factors influencing the realization of an adapted human aid when eating a meal in a dependent person. An observation of a meal during a hospitalization and an interview with the sick person and his caregiver are carried out independently. Between 15 days and a month after the first visit, excerpts from the film will be presented and commented by the dyad according to the technique of self-confrontation. A report of the thematic elements identified during the interviews will be proposed for validation by the dyad. This visit can be made during a scheduled appointment in the hospital, by videoconference or at home if the participants do not have access to a videoconference system.
- Conditions
- Parkinson Disease, Deglutition Disorders
- Keywords
- Dysphagia, Assistance feeding, Parkinson disease, Caregivers, Mealtime
- Medical subject headings
- Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Assisting (caregiver) / aided (patient with Parkinsonian syndrome) dyad | The dyad will be filmed during a meal and an interview with the sick person and his caregiver will be carried out independently. Between 15 days and a month after the first visit, excerpts from the film will be presented and commented by the dyad according to the technique of self-confrontation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strategies description
Description of the strategies designed and used by the assisting/aided dyad to feed dysphagic patients to perform the hand-to-mouth gesture in the context of Parkinson's disease or atypical parkinsonian syndrome during a meal, using filmed data and semi-directional interviews.
Measured: 13 months
Secondary outcomes (5)
Description of the perception of meal time, patient's point of view
Thematic analysis of the perception of meal timing, diet, meal assistance for the sick person.
Measured: 13 months
Description of the perception of meal time, helper's point of view
Thematic analysis of the perception of meal timing, diet, meal assistance for the caregiver
Measured: 13 months
Description of quality of life related to meal time
Identify factors that contribute to and detract from meal-related quality of life satisfaction.
Measured: 13 months
Identification of specific needs for educational programmes
Identify the needs of carers to adapt or place specific educational programmes
Measured: 13 months
Description of strategies put in place during meal time
Overview of the strategies put in place to promote a compromise between nutritional, safety and hedonic objectives
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Feb 2024
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margherita FABBRI, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898139
- Sponsor's protocol ID
- RC31/22/0527
- Other IDs
- 2023-A00393-42
- Acronym
- AideAlimPark
- Status last verified
- Dec 2025
- First submitted
- 31 May 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batchelor-Murphy MK, McConnell ES, Amella EJ, Anderson RA, Bales CW, Silva S, Barnes A, Beck C, Colon-Emeric CS. Experimental Comparison of Efficacy for Three Handfeeding Techniques in Dementia. J Am Geriatr Soc. 2017 Apr;65(4):e89-e94. doi: 10.1111/jgs.14728. Epub 2017 Feb 6.
PubMed 28165618Cosentino G, Avenali M, Schindler A, Pizzorni N, Montomoli C, Abbruzzese G, Antonini A, Barbiera F, Benazzo M, Benarroch EE, Bertino G, Cereda E, Clave P, Cortelli P, Eleopra R, Ferrari C, Hamdy S, Huckabee ML, Lopiano L, Marchese Ragona R, Masiero S, Michou E, Occhini A, Pacchetti C, Pfeiffer RF, Restivo DA, Rondanelli M, Ruoppolo G, Sandrini G, Schapira AHV, Stocchi F, Tolosa E, Valentino F, Zamboni M, Zangaglia R, Zappia M, Tassorelli C, Alfonsi E. A multinational consensus on dysphagia in Parkinson's disease: screening, diagnosis and prognostic value. J Neurol. 2022 Mar;269(3):1335-1352. doi: 10.1007/s00415-021-10739-8. Epub 2021 Aug 21.
PubMed 34417870Fabbri M, Coelho M, Abreu D, Guedes LC, Rosa MM, Godinho C, Cardoso R, Guimaraes I, Antonini A, Zibetti M, Lopiano L, Ferreira JJ. Dysphagia predicts poor outcome in late-stage Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:73-81. doi: 10.1016/j.parkreldis.2019.02.043. Epub 2019 Mar 2.
PubMed 30902528Flora L, Berkesse A, Payot A, Dumez V, Karazivan P. [THE APPLICATION OF AN INTEGRATED MODEL OF PARTNERSHIP- PATIENT IN THE PROFESSIONALS OF THE HEALTH TRAINING: TOWARDS NEW ONE HUMANIST PARADIGM AND ETHICS OF CO-CONSTRUCTION KNOWLEDGES IN HEALTH]. J Int Bioethique Ethique Sci. 2016 Mar-Jun;27(1-2):59-72, 228. French.
PubMed 27305793Howells SR, Cornwell PL, Ward EC, Kuipers P. Living with Dysphagia in the Community: Caregivers "do whatever it takes.". Dysphagia. 2021 Feb;36(1):108-119. doi: 10.1007/s00455-020-10117-y. Epub 2020 Apr 24.
PubMed 32333212Leow LP, Huckabee ML, Anderson T, Beckert L. The impact of dysphagia on quality of life in ageing and Parkinson's disease as measured by the swallowing quality of life (SWAL-QOL) questionnaire. Dysphagia. 2010 Sep;25(3):216-20. doi: 10.1007/s00455-009-9245-9. Epub 2009 Aug 13.
PubMed 19680723Liu W, Williams K, Batchelor-Murphy M, Perkhounkova Y, Hein M. Eating performance in relation to intake of solid and liquid food in nursing home residents with dementia: A secondary behavioral analysis of mealtime videos. Int J Nurs Stud. 2019 Aug;96:18-26. doi: 10.1016/j.ijnurstu.2018.12.010. Epub 2019 Jan 3.
PubMed 30660444Liu W, Batchelor M, Williams K. Ease of use, feasibility and inter-rater reliability of the refined Cue Utilization and Engagement in Dementia (CUED) mealtime video-coding scheme. J Adv Nurs. 2020 Dec;76(12):3609-3622. doi: 10.1111/jan.14548. Epub 2020 Sep 30.
PubMed 32996629Liu W, Tripp-Reimer T, Williams K, Shaw C. Facilitators and barriers to optimizing eating performance among cognitively impaired older adults: A qualitative study of nursing assistants' perspectives. Dementia (London). 2020 Aug;19(6):2090-2113. doi: 10.1177/1471301218815053. Epub 2018 Nov 27.
PubMed 30482090Miller N, Noble E, Jones D, Burn D. Hard to swallow: dysphagia in Parkinson's disease. Age Ageing. 2006 Nov;35(6):614-8. doi: 10.1093/ageing/afl105.
PubMed 17047007Perry SE, Borders JC, Dakin AE, Troche MS. Characterizing Quality of Life in Caregivers of People with Parkinson's Disease and Dysphagia. Dysphagia. 2022 Jun;37(3):523-532. doi: 10.1007/s00455-021-10299-z. Epub 2021 May 15.
PubMed 33991229Pflug C, Bihler M, Emich K, Niessen A, Nienstedt JC, Flugel T, Koseki JC, Plaetke R, Hidding U, Gerloff C, Buhmann C. Critical Dysphagia is Common in Parkinson Disease and Occurs Even in Early Stages: A Prospective Cohort Study. Dysphagia. 2018 Feb;33(1):41-50. doi: 10.1007/s00455-017-9831-1. Epub 2017 Aug 21.
PubMed 28828545Pomey MP, Flora L, Karazivan P, Dumez V, Lebel P, Vanier MC, Debarges B, Clavel N, Jouet E. [The Montreal model: the challenges of a partnership relationship between patients and healthcare professionals]. Sante Publique. 2015 Jan-Feb;27(1 Suppl):S41-50. French.
PubMed 26168616Pu D, Yiu EML, Chan KMK. Factors associated with signs of aspiration in older adults: A prospective study. Geriatr Nurs. 2020 Sep-Oct;41(5):635-640. doi: 10.1016/j.gerinurse.2020.03.019. Epub 2020 May 10.
PubMed 32402573Schindler A, Pizzorni N, Cereda E, Cosentino G, Avenali M, Montomoli C, Abbruzzese G, Antonini A, Barbiera F, Benazzo M, Benarroch E, Bertino G, Clave P, Cortelli P, Eleopra R, Ferrari C, Hamdy S, Huckabee ML, Lopiano L, Marchese-Ragona R, Masiero S, Michou E, Occhini A, Pacchetti C, Pfeiffer RF, Restivo DA, Rondanelli M, Ruoppolo G, Sandrini G, Schapira A, Stocchi F, Tolosa E, Valentino F, Zamboni M, Zangaglia R, Zappia M, Tassorelli C, Alfonsi E. Consensus on the treatment of dysphagia in Parkinson's disease. J Neurol Sci. 2021 Nov 15;430:120008. doi: 10.1016/j.jns.2021.120008. Epub 2021 Sep 27.
PubMed 34624796
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describe to Better Understand, the Mealtime of People With Parkinson's Disease Dependent on Food Intake
- ClinicalTrials.gov ID
- NCT05898139
- Acronym / sponsor ID
- AideAlimPark / RC31/22/0527
- Conditions
- Parkinson Disease, Deglutition Disorders
- Keywords
- Dysphagia, Assistance feeding, Parkinson disease, Caregivers, Mealtime
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to describe strategies (verbal, non-verbal (gesture, intonation), and environmental), designed and used by the assisting/aided dyad to feed a dysphagic dependent person by articulating the safe and hedonic dimensions in the context of Parkinson's disease or atypical parkinsonian syndrome during a meal
Detailed description
It is described in the literature that being helped for the meal disrupts the pre-oral phase in the visual and proprioceptive afferences received by the sick person to prepare neurologically the other phases of swallowing. In cases of dysphagia, regardless of the cause, the need for food assistance is correlated with higher mortality and an increased risk of pneumonia. Thus, whether at home or in an establishment, human help is often put in place to facilitate the time of the meal, make it more effective (limitation of the duration of the meal, maximization of the nutritional amounts ingested) and safe (prevention of the occurrence of wrong driving). Our hypothesis is that representations about food and aid at meal times, as well as the attitudes of both the helper and the helped, are factors influencing the realization of an adapted human aid when eating a meal in a dependent person. An observation of a meal during a hospitalization and an interview with the sick person and his caregiver are carried out independently. Between 15 days and a month after the first visit, excerpts from the film will be presented and commented by the dyad according to the technique of self-confrontation. A report of the thematic elements identified during the interviews will be proposed for validation by the dyad. This visit can be made during a scheduled appointment in the hospital, by videoconference or at home if the participants do not have access to a videoconference system.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assisting (caregiver) / aided (patient with Parkinsonian syndrome) dyad | – | –The dyad will be filmed during a meal and an interview with the sick person and his caregiver will be carried out independently. Between 15 days and a month after the first visit, excerpts from the film will be presented and commented by the dyad according to the technique of self-confrontation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with typical or atypical parkinsonian syndrome and their caregiver
Key inclusion criteria (8 listed)
- Patient with typical or atypical Parkinsonian syndrome, collected in the medical record
- Indication of swallowing disorders or dysphagia, according to item 2.3 chewing and swallowing, part II of the MSD/UPDRS scale or collection in the medical record
- Person dependent on food (according to MDS/UPDRS - food tasks item, part II, 2.4 ≥ 2, to be help to cut food punctually
- Having a usual caregiver present for the meal.
- Affiliated person or beneficiary of a social security scheme.
Key exclusion criteria (6 listed)
- Individuals whose cognitive state does not allow simple questions to be answered, as judged by the neurologist
- Person fed exclusively by enteral nutrition.
- Patient who refuses to be filmed
- Patient who refuses to be filmed
- Protected patient: under guardianship, trusteeship or other legal protection, deprived of freedom by judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Strategies description
Time frame: 13 months
Description of the strategies designed and used by the assisting/aided dyad to feed dysphagic patients to perform the hand-to-mouth gesture in the context of Parkinson's disease or atypical parkinsonian syndrome during a meal, using filmed data and semi-directional interviews.
5 secondary outcomes
Description of the perception of meal time, patient's point of view
Time frame: 13 months
Description of the perception of meal time, helper's point of view
Time frame: 13 months
Description of quality of life related to meal time
Time frame: 13 months
Identification of specific needs for educational programmes
Time frame: 13 months
Description of strategies put in place during meal time
Time frame: 13 months
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 22 Dec 2025.
- Background: PubMed 28165618Batchelor-Murphy MK, McConnell ES, Amella EJ, Anderson RA, Bales CW, Silva S, Barnes A, Beck C, Colon-Emeric CS. Experimental Comparison of Efficacy for Three Handfeeding Techniques in Dementia. J Am Geriatr Soc. 2017 Apr;65(4):e89-e94. doi: 10.1111/jgs.14728. Epub 2017 Feb 6.
- Background: PubMed 34417870Cosentino G, Avenali M, Schindler A, Pizzorni N, Montomoli C, Abbruzzese G, Antonini A, Barbiera F, Benazzo M, Benarroch EE, Bertino G, Cereda E, Clave P, Cortelli P, Eleopra R, Ferrari C, Hamdy S, Huckabee ML, Lopiano L, Marchese Ragona R, Masiero S, Michou E, Occhini A, Pacchetti C, Pfeiffer RF, Restivo DA, Rondanelli M, Ruoppolo G, Sandrini G, Schapira AHV, Stocchi F, Tolosa E, Valentino F, Zamboni M, Zangaglia R, Zappia M, Tassorelli C, Alfonsi E. A multinational consensus on dysphagia in Parkinson's disease: screening, diagnosis and prognostic value. J Neurol. 2022 Mar;269(3):1335-1352. doi: 10.1007/s00415-021-10739-8. Epub 2021 Aug 21.
- Background: PubMed 30902528Fabbri M, Coelho M, Abreu D, Guedes LC, Rosa MM, Godinho C, Cardoso R, Guimaraes I, Antonini A, Zibetti M, Lopiano L, Ferreira JJ. Dysphagia predicts poor outcome in late-stage Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:73-81. doi: 10.1016/j.parkreldis.2019.02.043. Epub 2019 Mar 2.
- Background: PubMed 27305793Flora L, Berkesse A, Payot A, Dumez V, Karazivan P. [THE APPLICATION OF AN INTEGRATED MODEL OF PARTNERSHIP- PATIENT IN THE PROFESSIONALS OF THE HEALTH TRAINING: TOWARDS NEW ONE HUMANIST PARADIGM AND ETHICS OF CO-CONSTRUCTION KNOWLEDGES IN HEALTH]. J Int Bioethique Ethique Sci. 2016 Mar-Jun;27(1-2):59-72, 228. French.
- Background: PubMed 32333212Howells SR, Cornwell PL, Ward EC, Kuipers P. Living with Dysphagia in the Community: Caregivers "do whatever it takes.". Dysphagia. 2021 Feb;36(1):108-119. doi: 10.1007/s00455-020-10117-y. Epub 2020 Apr 24.
- Background: PubMed 19680723Leow LP, Huckabee ML, Anderson T, Beckert L. The impact of dysphagia on quality of life in ageing and Parkinson's disease as measured by the swallowing quality of life (SWAL-QOL) questionnaire. Dysphagia. 2010 Sep;25(3):216-20. doi: 10.1007/s00455-009-9245-9. Epub 2009 Aug 13.
- Background: PubMed 30660444Liu W, Williams K, Batchelor-Murphy M, Perkhounkova Y, Hein M. Eating performance in relation to intake of solid and liquid food in nursing home residents with dementia: A secondary behavioral analysis of mealtime videos. Int J Nurs Stud. 2019 Aug;96:18-26. doi: 10.1016/j.ijnurstu.2018.12.010. Epub 2019 Jan 3.
- Background: PubMed 32996629Liu W, Batchelor M, Williams K. Ease of use, feasibility and inter-rater reliability of the refined Cue Utilization and Engagement in Dementia (CUED) mealtime video-coding scheme. J Adv Nurs. 2020 Dec;76(12):3609-3622. doi: 10.1111/jan.14548. Epub 2020 Sep 30.
- Background: PubMed 30482090Liu W, Tripp-Reimer T, Williams K, Shaw C. Facilitators and barriers to optimizing eating performance among cognitively impaired older adults: A qualitative study of nursing assistants' perspectives. Dementia (London). 2020 Aug;19(6):2090-2113. doi: 10.1177/1471301218815053. Epub 2018 Nov 27.
- Background: PubMed 17047007Miller N, Noble E, Jones D, Burn D. Hard to swallow: dysphagia in Parkinson's disease. Age Ageing. 2006 Nov;35(6):614-8. doi: 10.1093/ageing/afl105.
- Background: PubMed 33991229Perry SE, Borders JC, Dakin AE, Troche MS. Characterizing Quality of Life in Caregivers of People with Parkinson's Disease and Dysphagia. Dysphagia. 2022 Jun;37(3):523-532. doi: 10.1007/s00455-021-10299-z. Epub 2021 May 15.
- Background: PubMed 28828545Pflug C, Bihler M, Emich K, Niessen A, Nienstedt JC, Flugel T, Koseki JC, Plaetke R, Hidding U, Gerloff C, Buhmann C. Critical Dysphagia is Common in Parkinson Disease and Occurs Even in Early Stages: A Prospective Cohort Study. Dysphagia. 2018 Feb;33(1):41-50. doi: 10.1007/s00455-017-9831-1. Epub 2017 Aug 21.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Margherita FABBRI principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Deglutition Disorders, run by University Hospital, Toulouse 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 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 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 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?
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?
Strategies description (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05898139, which also lists 17 linked publications.
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 22 Dec 2025.