Complex Neurodevelopmental DisorderCHUpercuNCT07303049
Cognitive Benefit of Intensive Rehabilitation Using Rhythmic Music Training in Children With Complex Neurodevelopmental Disorder
A study testing Intensive rhythmic musical training in people with Complex Neurodevelopmental Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In the wide range of studies carried out on neurodevelopmental disorders (NDD), rhythm disorders have been identified as a major cross-cutting component. The aim of our research is to evaluate the effect of intensive rhythm-based rehabilitation on rhythmic abilities and its generalization to attentional, executive and… Read more about this study
- Who is it for?
- Ages 8 years to 126 months
- Conditions the study is for
- Complex Neurodevelopmental Disorder
- What is being tested?
- Intensive rhythmic musical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to May 2026
- 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 8 years to 126 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of neurodevelopmental disorder involving at least two impairments (ADHD + DCD, ADHD + Dyslexia, Dyslexia + DCD, ADHD + Dyslexia + DCD), according to DSM-5 criteria (2015), established at the Language and Learning Disorders Reference Center (CRTLA) of Toulouse University Hospital.
- Aged between 8 years and 10 years 6 months.
- Enrolled in elementary school.
- Visual, auditory (with permitted aids), motor, oral and written expression and comprehension abilities sufficient, according to the investigator physician's assessment, to perform cognitive tests and follow the intervention.
- Patient beneficiary/affiliate of the French Social Security system.
- Signed informed consent from parent(s) / legal guardian(s) in accordance with French law and Good Clinical Practice, along with minor's assent.
- Authorization for image and sound recording.
Who cannot join
- Practice of a musical instrument during the current year (in a music school or leisure activity).
- Behavioral disorder making group practice difficult (e.g., oppositional defiant disorder) according to the investigator's opinion.
- Patient diagnosed with autism spectrum disorder or intellectual developmental disorder (IQ < 70).
- Patient with epilepsy (with or without treatment).
- Uncorrected hearing or visual impairment.
- Current treatment with psychostimulants or psychotropic drugs (notably methylphenidate, antidepressants).
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- Patient lacking access to a stable internet connection required for teleconsultation assessments.
- Any family or sociological condition preventing compliance with the procedures outlined in the study protocol, according to the investigator's opinion.
- Patient participating in another human research study involving experimental treatment or behavioral therapy.
- Ongoing rehabilitative care is not an exclusion criterion for the study.
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
Hôpital Purpan
Toulouse, Occitanie, 31300
Céline CHIGNAC, 05 67 77 10 93, chignac.c@chu-toulouse.fr
About this study
In the wide range of studies carried out on neurodevelopmental disorders (NDD), rhythm disorders have been identified as a major cross-cutting component. The aim of our research is to evaluate the effect of intensive rhythm-based rehabilitation on rhythmic abilities and its generalization to attentional, executive and reading skills.
Read the detailed description
Current knowledge of impaired rhythmic skills in NDD is based on a number of studies, mainly carried out with groups of children presenting either Attention Deficit Disorder with or without Hyperactivity (ADHD), Developmental Coordination Disorder (DCD) or Learning to Read Disorder (dyslexia, DYS). The authors highlighted an impairment of the temporal sphere, and more specifically a timing deficit. A few studies have already evaluated the effect of rhythm-based rehabilitation in children with isolated NDD (Flaugnacco et al., 2015; Habib et al., 2013; Jamey et al., 2024; Puyjarinet et al., 2020) and show an improvement in certain untrained cognitive functions (reading skills, phonological awareness, attention, working memory, inhibition).
The intervention, in groups of 6 children, takes place face-to-face, during a school vacation period over 5 consecutive days, 4 hours per day. The sessions are based on specific multimodal training and motor response using the djembe.
After an inclusion visit, all patients undergo a full neuropsychological assessment, which is repeated 2 months later (before-after design). These measurements will take place over one day at the Toulouse University Hospital, in person.
In the meantime, measurements of the assessment criteria are repeated daily before, during and after the intervention, according to a Single Case Experimental Design (SCED). Daily assessments, excluding weekends, will be performed and recorded via the Toulouse University Hospital's TéléO tool. A 5-days final evaluation phase will be carried out 3 months after the intervention to assess long-term effects.
- Conditions
- Complex Neurodevelopmental Disorder
- Being tested
- Intensive rhythmic musical training
- Keywords
- Complex neurodevelopmental disorder, Intensive rhythmic rehabilitation, Cognition, SCED, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive rhythmic musical trainingBehavioural
Participants undergo an intensive rhythmic training program using percussion instruments. The program takes place over one week, with daily sessions focused on rhythmic exercises. It focuses on developing motor coordination, timing, and cognitive skills through group-based rhythmic exercises and activities. Sessions include guided percussion practice designed to improve sensorimotor integration and enhance cognitive-motor performance.
| Study group | Role | What they receive |
|---|---|---|
| Children with complex neurodevelopmental disorders undergoing intensive rhythmic musical training | Experimental | Not described Receives: Behavioral: Intensive rhythmic musical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhythmic structure reproduction task (Stambak-type test)
Measured: From week 2 after enrollment to week 14
Secondary outcomes (26)
Spontaneous tempo tapping task (SCED methodology)
Measured: From week 2 after enrollment to week 14
Behavioral observation grid in ecological settings (SCED methodology)
Measured: From week 2 after enrollment to week 14
Text reading task (speed/accuracy ratio) (SCED methodology)
Measured: From week 2 after enrollment to week 14
Line orientation judgment task (SCED methodology)
Measured: From week 2 after enrollment to week 14
Explicit sensorimotor timing: Synchronization tapping task with a metronome
Measured: Week 1 and week 17
Explicit perceptual timing: Beat alignment task
Measured: Week 1 and 17
Implicit motor timing (emergent timing): DALS (Draw A Line Slowly)
Measured: Week 1 and week 17
Implicit motor timing (emergent timing): WALS (Walk A Line Slowly)
Measured: Week 1 and week 17
Selective visual attention: Barre-Joe Test
Measured: Week 1 and week 17
Auditory attention: Auditory attention and associated response test
Measured: Week 1 and week 17
Planning: 8 Maze Test or Rey-Osterrieth Complex Figure with planning instructions
Measured: Week 1 and week 17
Cognitive flexibility: Children's Card Sorting Test - KCST
Measured: Week 1 and week 17
Inhibition: Child Tapping Test
Measured: Week 1 and week 17
Auditory-verbal: Digit Span Task
Measured: Week 1 and week 17
Visuospatial: Spatial memory task
Measured: Week 1 and week 17
Pseudoword reading: Evaléo (ages 6-15)
Measured: Week 1 and week 17
Text reading: Evaléo (ages 6-15), Forms A and B
Measured: Week 1 and week 17
Test assessing passive lexical knowledge: Evaléo (ages 6-15)
Measured: Week 1 and week 17
Rapid color naming task: Evaléo (ages 6-15)
Measured: Week 1 and week 17
Tapping subtest from NEPSY-II
Measured: Week 1 and week 17
Manual dexterity (MABC-2)
Measured: Week 1 and week 17
Temporal questionnaire for children (QTE)
Measured: Week 1 and week 17
MDI-C (Children's Depression Inventory: Self-esteem subscale, ages 8-17)
Measured: Week 1 and week 17
Parent questionnaire: Strengths and Difficulties Questionnaire (SDQ-Fra)
Measured: Week 1 and week 17
Child self-assessment from a predefined list of daily activities that may pose difficulties (ecological assessment)
Measured: Week 1 and week 17
Likert scale assessing satisfaction across various criteria
Measured: Week 17 after enrollment
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 startJan 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Neurodevelopmental DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303049
- Sponsor's protocol ID
- RC31/24/0541
- Other IDs
- ID-RCB : 2025-A01672-47
- Acronym
- CHUpercu
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Cognitive Benefit of Intensive Rehabilitation Using Rhythmic Music Training in Children With Complex Neurodevelopmental Disorder
- ClinicalTrials.gov ID
- NCT07303049
- Acronym / sponsor ID
- CHUpercu / RC31/24/0541
- Conditions
- Complex Neurodevelopmental Disorder
- Keywords
- Complex neurodevelopmental disorder, Intensive rhythmic rehabilitation, Cognition, SCED, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (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.
In the wide range of studies carried out on neurodevelopmental disorders (NDD), rhythm disorders have been identified as a major cross-cutting component. The aim of our research is to evaluate the effect of intensive rhythm-based rehabilitation on rhythmic abilities and its generalization to attentional, executive and reading skills.
Detailed description
Current knowledge of impaired rhythmic skills in NDD is based on a number of studies, mainly carried out with groups of children presenting either Attention Deficit Disorder with or without Hyperactivity (ADHD), Developmental Coordination Disorder (DCD) or Learning to Read Disorder (dyslexia, DYS). The authors highlighted an impairment of the temporal sphere, and more specifically a timing deficit. A few studies have already evaluated the effect of rhythm-based rehabilitation in children with isolated NDD (Flaugnacco et al., 2015; Habib et al., 2013; Jamey et al., 2024; Puyjarinet et al., 2020) and show an improvement in certain untrained cognitive functions (reading skills, phonological awareness, attention, working memory, inhibition).
The intervention, in groups of 6 children, takes place face-to-face, during a school vacation period over 5 consecutive days, 4 hours per day. The sessions are based on specific multimodal training and motor response using the djembe.
After an inclusion visit, all patients undergo a full neuropsychological assessment, which is repeated 2 months later (before-after design). These measurements will take place over one day at the Toulouse University Hospital, in person.
In the meantime, measurements of the assessment criteria are repeated daily before, during and after the intervention, according to a Single Case Experimental Design (SCED). Daily assessments, excluding weekends, will be performed and recorded via the Toulouse University Hospital's TéléO tool. A 5-days final evaluation phase will be carried out 3 months after the intervention to assess long-term effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with complex neurodevelopmental disorders undergoing intensive rhythmic musical training | Experimental | Behavioral: Intensive rhythmic musical training |
Who may qualify
- Ages
- 8 years to 126 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Diagnosis of neurodevelopmental disorder involving at least two impairments (ADHD + DCD, ADHD + Dyslexia, Dyslexia + DCD, ADHD + Dyslexia + DCD), according to DSM-5 criteria (2015), established at the Language and Learning Disorders Reference Center (CRTLA) of Toulouse University Hospital.
- Aged between 8 years and 10 years 6 months.
- Enrolled in elementary school.
- Visual, auditory (with permitted aids), motor, oral and written expression and comprehension abilities sufficient, according to the investigator physician's assessment, to perform cognitive tests and follow the intervention.
- Patient beneficiary/affiliate of the French Social Security system.
Key exclusion criteria (10 listed)
- Practice of a musical instrument during the current year (in a music school or leisure activity).
- Behavioral disorder making group practice difficult (e.g., oppositional defiant disorder) according to the investigator's opinion.
- Patient diagnosed with autism spectrum disorder or intellectual developmental disorder (IQ < 70).
- Patient with epilepsy (with or without treatment).
- Uncorrected hearing or visual impairment.
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 |
|---|---|---|
| Intensive rhythmic musical trainingParticipants undergo an intensive rhythmic training program using percussion instruments. The program takes place over one week, with daily sessions focused on rhythmic exercises. It focuses on developing motor coordination, timing, and cognitive skills through group-based rhythmic exercises and activities. Sessions include guided percussion practice designed to improve sensorimotor integration and enhance cognitive-motor performance. | Behavioural | Children with complex neurodevelopmental disorders undergoing intensive rhythmic musical training |
Primary outcome
Rhythmic structure reproduction task (Stambak-type test)
Time frame: From week 2 after enrollment to week 14
26 secondary outcomes
Spontaneous tempo tapping task (SCED methodology)
Time frame: From week 2 after enrollment to week 14
Behavioral observation grid in ecological settings (SCED methodology)
Time frame: From week 2 after enrollment to week 14
Text reading task (speed/accuracy ratio) (SCED methodology)
Time frame: From week 2 after enrollment to week 14
Line orientation judgment task (SCED methodology)
Time frame: From week 2 after enrollment to week 14
Explicit sensorimotor timing: Synchronization tapping task with a metronome
Time frame: Week 1 and week 17
Explicit perceptual timing: Beat alignment task
Time frame: Week 1 and 17
Implicit motor timing (emergent timing): DALS (Draw A Line Slowly)
Time frame: Week 1 and week 17
Implicit motor timing (emergent timing): WALS (Walk A Line Slowly)
Time frame: Week 1 and week 17
Selective visual attention: Barre-Joe Test
Time frame: Week 1 and week 17
Auditory attention: Auditory attention and associated response test
Time frame: Week 1 and week 17
Planning: 8 Maze Test or Rey-Osterrieth Complex Figure with planning instructions
Time frame: Week 1 and week 17
Cognitive flexibility: Children's Card Sorting Test - KCST
Time frame: Week 1 and week 17
Inhibition: Child Tapping Test
Time frame: Week 1 and week 17
Auditory-verbal: Digit Span Task
Time frame: Week 1 and week 17
Visuospatial: Spatial memory task
Time frame: Week 1 and week 17
Pseudoword reading: Evaléo (ages 6-15)
Time frame: Week 1 and week 17
Text reading: Evaléo (ages 6-15), Forms A and B
Time frame: Week 1 and week 17
Test assessing passive lexical knowledge: Evaléo (ages 6-15)
Time frame: Week 1 and week 17
Rapid color naming task: Evaléo (ages 6-15)
Time frame: Week 1 and week 17
Tapping subtest from NEPSY-II
Time frame: Week 1 and week 17
Manual dexterity (MABC-2)
Time frame: Week 1 and week 17
Temporal questionnaire for children (QTE)
Time frame: Week 1 and week 17
MDI-C (Children's Depression Inventory: Self-esteem subscale, ages 8-17)
Time frame: Week 1 and week 17
Parent questionnaire: Strengths and Difficulties Questionnaire (SDQ-Fra)
Time frame: Week 1 and week 17
Child self-assessment from a predefined list of daily activities that may pose difficulties (ecological assessment)
Time frame: Week 1 and week 17
Likert scale assessing satisfaction across various criteria
Time frame: Week 17 after enrollment
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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive rhythmic musical training in people with Complex Neurodevelopmental Disorder, 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 7 inclusion and 10 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: opening soon, 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 Céline CHIGNAC (05 67 77 10 93, chignac.c@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhythmic structure reproduction task (Stambak-type test) (time frame: From week 2 after enrollment to week 14). 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.