Autism DisorderMoDIDolNCT07302048
Impact and Determinants of Success of a Mobile Multidisciplinary Intervention System Specialized in Pain Management for Patients With Moderate to Severe Intellectual Development Disorder, Isolated or Associated With an ASD or Multiple Disability
A study testing MoDIDol intervention in people with Autism Disorder and Multiple Disabilities, run by University Hospital, Brest at 1 site in France.
Trial summary
Pain is described by patients with a Neurodevelopmental Disorder (NDD), including Autism Spectrum Disorder (ASD), Intellectual Development Disorder (IDD) or multiple disabilities, and the family as one of the main associated disorders; its management is also one of the main concerns of families and professionals. Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Autism Disorder, Multiple Disabilities, Pain
- What is being tested?
- MoDIDol intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2025to 20 Apr 2028
- 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 Up to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged from birth up to 24 years inclusive (i.e., under 25 years old)
- Medical diagnosis of intellectual disability (ID), isolated or associated with autism spectrum disorder (ASD), developmental disorder (DD), or profound multiple disabilities, based on international classification systems (ICD-11 or DSM-5)
- Confirmed probable or definite pain diagnosis, as validated by the MoDIDol team
- PGIC score ≥ 3
- Living in or receiving care in the departments of Finistère, Côtes-d'Armor, or Morbihan
- Written informed consent provided by parents, legal guardians, or holders of parental authority, authorizing data collection for research and publication purposes
- Affiliated with or benefiting from a French national health insurance scheme
Who cannot join
- More than three places of residence and/or care settings
- Parents or legal guardians who do not have sufficient language or comprehension skills to provide informed consent or complete study questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Brest - Hôpital Morvan
Brest, 29200
Philippe J LE MOINE, MD, +332 98 22 39 56, philippe.lemoine@chu-brest.fr
About this study
Official title: Impact and Determinants of Success of a Mobile Multidisciplinary Intervention System Specialized in Pain Management for Patients With Moderate to Severe Intellectual Development Disorder, Isolated or Associated With an ASD or Multiple Disability - MoDIDol
Pain is described by patients with a Neurodevelopmental Disorder (NDD), including Autism Spectrum Disorder (ASD), Intellectual Development Disorder (IDD) or multiple disabilities, and the family as one of the main associated disorders; its management is also one of the main concerns of families and professionals. At present, there is no validated and tested pain management system in populations facing complex pain situations. In response to the lack of a pain management services, a multi-disciplinary mobile team was set up in September 2022 at the Brest University Hospital (Mobile Pain Handicap Team Intellectual Disability 0-25 years; MoDIDol). This team offers a specific protocol for the assessment and management of pain that takes into account the social and family environment, the living context and the clinical characteristics of patients (children, adolescents and young adults (0-25 years) with IDD, ASD or multiple disabilities). The team includes at least one paediatrician specialising in the assessment and treatment of pain and a nurse, and travels to patients' usual living environments.
Read the detailed description
The MoDIDol team intervenes at the request of parents or professionals in complex situations involving pain or behavioural problems suggestive of pain, unresolved despite previous treatment. Parents and professionals learn about the MoDIDol team through flyers and information provided by associations and organisations supporting people with disabilities (associations, CRDI, etc.).
Once they are included in the study and after consent has been signed, multidisciplinary follow-up consultations are carried out by the MoDIDol team for pain management (every 6 weeks).
At the same time, three data collection sessions are planned for the participants, 3 months apart. Questionnaires are completed at each point by dedicated study staff. Interviews are conducted at 6-month intervals among a representative sample of professionals and parents.
- Being tested
- MoDIDol intervention
- Keywords
- Pain, Children, Adolescents, young adults, Intellectual Developmental Disability, Autism Spectrum Disorder, multiple disabilities, mobile team
- Medical subject headings
- Autistic Disorder, Pain, Intellectual Disability, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoDIDol interventionProcedure or surgery
Multidisciplinary mobile intervention system specialising in pain management for patients with moderate to severe intellectual development disorders, isolated or associated with ASD or multiple disabilities.
Treatment recommendations, pain assessment, training in scales, follow-up consultations every 6 weeks for 6 months, continued if the situation is not resolved, call at 12 months.
| Study group | Role | What they receive |
|---|---|---|
| children or young adults with IDD, ASD or multiple disabilities | Experimental | Single arm study
Interventions are :
* parents education for NCCPC and PPP by a pain specialized nurse at T1
* parents fullfilling of questionnaires à T1, T2 and T3 with study engineer Receives: Procedure: MoDIDol intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Clinical Improvement at 6 months
The primary outcome is the patient's global clinical improvement as perceived by family caregivers and/or institutional professionals, using the Patient Global Impression of Change (PGIC) scale after 6 months of care provided by the MoDIDol team. Improvement is defined as a PGIC score of 1 or 2 out of 7. scale from 1 to 7, higher scores mean worse outcome.
Measured: From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3)
Secondary outcomes (19)
Global Clinical Improvement at 3 months
Global clinical improvement of the patient, as reported by caregivers and/or professionals, measured using the Patient Global Impression of Change (PGIC) scale after 3 months of MoDIDol care. Improvement is defined as a PGIC score of or 2 out of 7. Scale from 1 to 7, higher scores mean worse outcome.
Measured: From baseline to the end of 3 months of treatment with the MoDIDoL system, assessed up to 3 months (T2)
Non Communicating Children's Pain Checklist (NCCPC) Pain Intensity Scores at T1, T2, and T3
Pain intensity will be assessed using the french version of Non Communicating Children's Pain Checklist (NCCPC) scale at baseline (T1), 3 months (T2), and 6 months (T3). The full rating is based on a 90-point scale : 4-point scale (0 : not observed ; 3 : frequently) for 30 behavioral assessments. But some behaviors can be omitted when non applicable (NA). Pain is mild if score is between 6 and 10, and moderate to severe if score is 11 or more.
Measured: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.
Pediatric Pain Profile (PPP) Pain Intensity Scores at T1, T2, and T3
Pain intensity will be assessed using the french version of Pediatric Pain Profile (PPP) scale at baseline (T1), 3 months (T2), and 6 months (T3). 20 behaviors are to be rated from 0 = not at all to 3 = completely. Pain is moderate to severe if score is 14/60 or above.
Measured: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.
Non Communicating Children's Pain Checklist (NCCPC) Pain Category Change
Patients will be categorized based on the french version of Non Communicating Children's Pain Chlecklist (NCCPC) (<6 : no pain; 6 to10 : mild pain; >10 : moderate to severe pain) scores to evaluate changes in pain category from T1 to T2 and T2 to T3. The full rating is based on a 90-point scale : 4-point scale (0 : not observed ; 3 : frequently) for 30 behavioral assessments. But some behaviors can be omitted when non applicable (NA). Pain is mild if score is between 6 and 10, and moderate to severe if score is 11 or more.
Measured: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Pediatric Pain Profile Pain Category Change
Patients will be categorized based on french version of Pediatric Pain Profile (PPP) (<14; > or =14) scores to evaluate changes in pain category from T1 to T2 and T2 to T3. Twenty behaviors are to be rated from 0 = not at all to 3 = completely. Pain is moderate to severe if score is 14/60 or above.
Measured: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Non Communicating Children's Pain Checklist (NCCPC) Pain Behavior Profiles
Behavioral indicators of pain will be documented using the item-based responses from Non Communicating Children's Pain Checklist (NCCPC) scale at T1. The full rating is based on a 90-point scale : 4-point scale (0 : not observed ; 3 : frequently) for 30 behavioral assessments. But some behaviors can be omitted when non applicable (NA). Pain is mild if score is between 6 and 10, and moderate to severe if score is 11 or more.
Measured: Baseline (T1)
Pediatric Pain Profile Pain Behavior Profiles
Behavioral indicators of pain will be documented using the item-based responses from Pediatric Pain Profile (PPP) scale at T1. Behaviours are to be assessed from 0 = not at all to 3 = completely (score from 0 to 60; pain if score > 14).
Measured: Baseline (T1)
Behavioral Disturbance Evolution
Frequency (0:never to 4: At least once an hour) and severity (1: mild to 3: severe) of three types of behaviors (self-injurious behaviors, stereotypical behaviors, and aggressive/destructive behaviors) will be assessed with the Behavior Problems Inventory (BPI) scale at T1, T2, and T3.
Measured: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.
PedsQL Patient Quality of Life Scores
Quality of life will be assessed using Pediatric Quality of Life Inventory (PedsQL) for patients without profound disabilities on a five-point Likert scale (from 0: Never/Bad; to 4: Almost Always/Excellent) for 15 items at T1, T2, and T3.
Measured: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
PolyQoL Patient Quality of Life Scores
Quality of life will be assessed using Quality of Life Scale for People with polyhandicap (PolyQoL) for patients with profound multiple disabilities on a five-point Likert scale (from 1: very bad; to 5: very goodt) for 21 items at T1, T2, and T3.
Measured: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Sleep Quality Scores
Sleep disorders will be measured with the Sleep Disturbance Scale for Children (SDSC) scale on a five-point Likert scale (from 1: never; to 5: every day) for 25 items at T1, T2, and T3.
Measured: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Parental Quality of Life
Parental quality of life will be assessed using the World Health Organization Quality of Life (WHOQOL-BREF) across four domains rated on a 5-point Likert scale (score from 1 to 5) for 26 items at T1, T2, and T3.
Measured: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Parental Stress
Parental stress will be evaluated using the Parenting Stress Index (PSI-4) at T1, T2, and T3. This questionnaire includes 120 items divided in two categories (stressors associated with the child domain, or with de parent domain) rated on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree". The total score of stress is obtained by adding up the results. The higher the value is, the higher the stress.
Measured: Baseline (T1), 3 months (T2), and 6 months (T3)
Determinants of Success
Individual (e.g., diagnosis, development level, sensory profile) and environmental (e.g., living environment, type of care) factors will be analyzed in relation to PGIC (Patient Global Impression of Change) score at T3.
Measured: From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3)
Pain Mechanism, Localization, and Etiology
Pain causes will be described according to the mechanism (nociceptive, neuropathic, nociplastic), location, and etiology. Patients with intellectual deficiency are not able to describe their pain because of verbal impairment. Qualitative informations are available through parents and professionnal observations. Evaluation is based on physical examination, specialized medical advice (dental, ENT, ...) and additional examinations, such as laboratory or medical imaging, if needed. These description are build at T1 as hypothesis and may be specified depending on developments during treatment.
Measured: Pain mechanism, location and etiology are determined at T1 but can be revised during the 6 months patient follow up
Analgesic and Behavioral Treatments
Description of treatments (indication and dosage) for pain and behavior at T2 and T3.
Measured: From baseline to the end of 3 months (T2) and 6 months (T3) of treatment with the MoDIDol system
Psychometric Properties of Non Communicating Children's Pain Checklist (NCCPC) Scale
Internal consistency and structural validity of the french version of Non Communicating Children's Pain Checklist (NCCPC) (for patients with ASD) scale will be assessed.
Measured: Through study completion, an average of 6 months after baseline.
Psychometric Properties of Pediaric Pain Profile Scale
Internal consistency and structural validity of the french version of Pediatric Pain Profile (PPP) scale will be assessed.
Measured: Through study completion, an average of 6 months after baseline.
Qualitative Interviews with Parents and Professionals
Impact of MoDIDol will be assessed through semi-structured interviews before (T1) and after (T3) of the intervention. Themes include daily impact of pain, beliefs, use of pain assessment tools, and perceived value of the mobile team
Measured: Baseline (T1) and after 6 months (T3) of treatment with the MoDIDol system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start14 Oct 2025
- Primary completion20 Apr 2028 (estimated)
- Study completion20 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- MoDIDol is a monocentric, prospective, non-comparative interventional study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, Université de Bretagne Occidentale, Brest-France, Fondation Perce Neige
- Responsible party
- Sponsor
- Investigators
- Philippe J LE MOINE, MD, Principal investigator, CHU de BrestAmandine DUBOIS, PhD, Study director, Université de Bretagne Occidentale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302048
- Sponsor's protocol ID
- 29BRC24.0282
- Acronym
- MoDIDol
- Status last verified
- Dec 2025
- First submitted
- 3 Jul 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Determinants of Success of a Mobile Multidisciplinary Intervention System Specialized in Pain Management for Patients With Moderate to Severe Intellectual Development Disorder, Isolated or Associated With an ASD or Multiple Disability - MoDIDol
- ClinicalTrials.gov ID
- NCT07302048
- Acronym / sponsor ID
- MoDIDol / 29BRC24.0282
- Keywords
- Pain, Children, Adolescents, young adults, Intellectual Developmental Disability, Autism Spectrum Disorder, multiple disabilities, mobile team
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Fondation de France, Université de Bretagne Occidentale, Brest-France, Fondation Perce Neige
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 20 Apr 2028 (estimated)
- Study completion
- 20 Apr 2028 (estimated)
- First posted
- 24 Dec 2025 (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.
Pain is described by patients with a Neurodevelopmental Disorder (NDD), including Autism Spectrum Disorder (ASD), Intellectual Development Disorder (IDD) or multiple disabilities, and the family as one of the main associated disorders; its management is also one of the main concerns of families and professionals. At present, there is no validated and tested pain management system in populations facing complex pain situations. In response to the lack of a pain management services, a multi-disciplinary mobile team was set up in September 2022 at the Brest University Hospital (Mobile Pain Handicap Team Intellectual Disability 0-25 years; MoDIDol). This team offers a specific protocol for the assessment and management of pain that takes into account the social and family environment, the living context and the clinical characteristics of patients (children, adolescents and young adults (0-25 years) with IDD, ASD or multiple disabilities). The team includes at least one paediatrician specialising in the assessment and treatment of pain and a nurse, and travels to patients' usual living environments.
Detailed description
The MoDIDol team intervenes at the request of parents or professionals in complex situations involving pain or behavioural problems suggestive of pain, unresolved despite previous treatment. Parents and professionals learn about the MoDIDol team through flyers and information provided by associations and organisations supporting people with disabilities (associations, CRDI, etc.).
Once they are included in the study and after consent has been signed, multidisciplinary follow-up consultations are carried out by the MoDIDol team for pain management (every 6 weeks).
At the same time, three data collection sessions are planned for the participants, 3 months apart. Questionnaires are completed at each point by dedicated study staff. Interviews are conducted at 6-month intervals among a representative sample of professionals and parents.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MoDIDol is a monocentric, prospective, non-comparative interventional study
| Arm | Type | Receives |
|---|---|---|
| children or young adults with IDD, ASD or multiple disabilities | Experimental | Procedure: MoDIDol interventionSingle arm study Interventions are : * parents education for NCCPC and PPP by a pain specialized nurse at T1 * parents fullfilling of questionnaires à T1, T2 and T3 with study engineer |
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged from birth up to 24 years inclusive (i.e., under 25 years old)
- Medical diagnosis of intellectual disability (ID), isolated or associated with autism spectrum disorder (ASD), developmental disorder (DD), or profound multiple disabilities, based on international classification systems (ICD-11 or DSM-5)
- Confirmed probable or definite pain diagnosis, as validated by the MoDIDol team
- PGIC score ≥ 3
- Living in or receiving care in the departments of Finistère, Côtes-d'Armor, or Morbihan
Key exclusion criteria (2 listed)
- More than three places of residence and/or care settings
- Parents or legal guardians who do not have sufficient language or comprehension skills to provide informed consent or complete study questionnaires
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 |
|---|---|---|
| MoDIDol interventionMultidisciplinary mobile intervention system specialising in pain management for patients with moderate to severe intellectual development disorders, isolated or associated with ASD or multiple disabilities. Treatment recommendations, pain assessment, training in scales, follow-up consultations every 6 weeks for 6 months, continued if the situation is not resolved, call at 12 months. | Procedure or surgery | children or young adults with IDD, ASD or multiple disabilities |
Primary outcome
Global Clinical Improvement at 6 months
Time frame: From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3)
The primary outcome is the patient's global clinical improvement as perceived by family caregivers and/or institutional professionals, using the Patient Global Impression of Change (PGIC) scale after 6 months of care provided by the MoDIDol team. Improvement is defined as a PGIC score of 1 or 2 out of 7. scale from 1 to 7, higher scores mean worse outcome.
19 secondary outcomes
Global Clinical Improvement at 3 months
Time frame: From baseline to the end of 3 months of treatment with the MoDIDoL system, assessed up to 3 months (T2)
Non Communicating Children's Pain Checklist (NCCPC) Pain Intensity Scores at T1, T2, and T3
Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.
Pediatric Pain Profile (PPP) Pain Intensity Scores at T1, T2, and T3
Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.
Non Communicating Children's Pain Checklist (NCCPC) Pain Category Change
Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Pediatric Pain Profile Pain Category Change
Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Non Communicating Children's Pain Checklist (NCCPC) Pain Behavior Profiles
Time frame: Baseline (T1)
Pediatric Pain Profile Pain Behavior Profiles
Time frame: Baseline (T1)
Behavioral Disturbance Evolution
Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.
PedsQL Patient Quality of Life Scores
Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
PolyQoL Patient Quality of Life Scores
Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Sleep Quality Scores
Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Parental Quality of Life
Time frame: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system
Parental Stress
Time frame: Baseline (T1), 3 months (T2), and 6 months (T3)
Determinants of Success
Time frame: From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3)
Pain Mechanism, Localization, and Etiology
Time frame: Pain mechanism, location and etiology are determined at T1 but can be revised during the 6 months patient follow up
Analgesic and Behavioral Treatments
Time frame: From baseline to the end of 3 months (T2) and 6 months (T3) of treatment with the MoDIDol system
Psychometric Properties of Non Communicating Children's Pain Checklist (NCCPC) Scale
Time frame: Through study completion, an average of 6 months after baseline.
Psychometric Properties of Pediaric Pain Profile Scale
Time frame: Through study completion, an average of 6 months after baseline.
Qualitative Interviews with Parents and Professionals
Time frame: Baseline (T1) and after 6 months (T3) of treatment with the MoDIDol system
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 24 Dec 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Philippe J LE MOINE, MD principal investigator
CHU de Brest
Amandine DUBOIS, PhD study director
Université de Bretagne Occidentale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoDIDol intervention in people with Autism Disorder and Multiple Disabilities, run by University Hospital, Brest 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 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 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?
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 Philippe LE MOINE, MD (+332 98 22 39 56, philippe.lemoine@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Clinical Improvement at 6 months (time frame: From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3)). 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 24 Dec 2025.