Alternating HemiplegiaTREAT-AHCNCT06007521
Validation of a Clinical Assessment Scale Specific to Alternating Hemiplegia
An observational study of Alternating Hemiplegia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Alternating Hemiplegia of Childhood (AHC) is a very rare neurological disorder of genetic origin, combining paroxysmal episodes and neurodevelopmental impairment. The disease is generally sporadic, and its incidence has been estimated at 1 in 100,000 births, with around 500 cases published worldwide. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Alternating Hemiplegia
- What is being tested?
- interview with neurologist
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2023to 19 Nov 2023
- 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 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients likely to participate in the study will be identified within the ESEFNP Department - Clinical Epileptology, Sleep Disorders, Functional Child Neurology, Hôpital Femme Mère Enfant, (HCL) as part of their regular medical follow-up. 20 AHC patients will be included in this study.
Who may be able to join
- Patient with confirmed diagnosis of AHC, unrestricted age range 0-99 years
- At least one parent and/or legal guardian who understands and speaks the national language
- Adult patients :
- Gathering of the non-opposition of the patient and/or his legal representative
- Minor patients :
- Collection of non-opposition from parents/guardians
Who cannot join
- Patient's refusal to participate in the study
- Patient under court protection, unable to give consent
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Epileptologie Clinique, des Troubles du Sommeil et de Neurologie Fonctionnelle de l'Enfant
Bron, Rhone, 69500
About this study
Alternating Hemiplegia of Childhood (AHC) is a very rare neurological disorder of genetic origin, combining paroxysmal episodes and neurodevelopmental impairment. The disease is generally sporadic, and its incidence has been estimated at 1 in 100,000 births, with around 500 cases published worldwide. The true prevalence of AHC may be underestimated due to a lack of understanding of the disease and a high degree of phenotypic heterogeneity.
It should be noted that, to date, it is difficult to assess the clinical characteristics of AHC patients in a homogeneous way. The lack of disease-specific clinical outcome measures therefore constitutes a critical node for advancing AHC research. In addition, recognition of the pattern of movement disorders and the ability to classify their severity are very important and useful for the clinician. Homogeneous disease assessment will help plan rehabilitative and pharmacological interventions, facilitate monitoring of treatment outcomes, and predict prognosis.
Read more
This is why an AHC assessment scale have been developed in collaboration with clinical teams from the IAHCRC consortium.
The scale has already been tested and validated on Italian and Spanish patients. The aim of this study is therefore to validate the use of this same scale on our French population of AHC patients. The hypothesis of the study is that the practical use of this scale specific to alternating hemiplegia is reproducible. To this end, all the items on the scale will be scored independently for each patient by 4 neuropediatricians with expertise in the disease, in order to observe the reproducibility of the results obtained with this scale. The scale will be used for twenty AHC patients of all ages.
- Conditions
- Alternating Hemiplegia
- Being tested
- interview with neurologist
- Keywords
- Alternating Hemiplegia of Childhood, rating scale
- Medical subject headings
- Alternating hemiplegia of childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interview with neurologistOther
interview with neurologist
| Study group | Role | What they receive |
|---|---|---|
| Patients with alternating hemiplegia | Patients with alternating hemiplegia, from 0 to 99 years old Receives: Other: interview with neurologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint : - missing data from the scale <5 - mean scores compared between the 4 neurologists are close to the scale's mid-point, i.e. floor and ceiling effects are < 20%, and skewness statistics are between 21 and 11
All statistical tests will be performed using SPSS version 24.0 statistical software, and P < 0.05 will be considered significant.
Validation of the use of the scale based on the results obtained independently by the 4 expert neurologists using a composite primary endpoint consisting of three criteria:
- missing data from the scale <5
- mean scores compared between the 4 neurologists are close to the scale's mid-point, i.e. floor and ceiling effects are < 20%, and skewness statistics are between 21 and 11.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start18 Nov 2023
- Primary completion19 Nov 2023
- Study completion19 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alternating HemiplegiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007521
- Sponsor's protocol ID
- 69HCL23_0804
- Acronym
- TREAT-AHC
- Status last verified
- Feb 2025
- First submitted
- 8 Aug 2023
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Clinical Assessment Scale Specific to Alternating Hemiplegia
- ClinicalTrials.gov ID
- NCT06007521
- Acronym / sponsor ID
- TREAT-AHC / 69HCL23_0804
- Conditions
- Alternating Hemiplegia
- Keywords
- Alternating Hemiplegia of Childhood, rating scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Nov 2023 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 19 Nov 2023 (actual)
- First posted
- 23 Aug 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.
Alternating Hemiplegia of Childhood (AHC) is a very rare neurological disorder of genetic origin, combining paroxysmal episodes and neurodevelopmental impairment. The disease is generally sporadic, and its incidence has been estimated at 1 in 100,000 births, with around 500 cases published worldwide. The true prevalence of AHC may be underestimated due to a lack of understanding of the disease and a high degree of phenotypic heterogeneity.
It should be noted that, to date, it is difficult to assess the clinical characteristics of AHC patients in a homogeneous way. The lack of disease-specific clinical outcome measures therefore constitutes a critical node for advancing AHC research. In addition, recognition of the pattern of movement disorders and the ability to classify their severity are very important and useful for the clinician. Homogeneous disease assessment will help plan rehabilitative and pharmacological interventions, facilitate monitoring of treatment outcomes, and predict prognosis.
This is why an AHC assessment scale have been developed in collaboration with clinical teams from the IAHCRC consortium.
The scale has already been tested and validated on Italian and Spanish patients. The aim of this study is therefore to validate the use of this same scale on our French population of AHC patients. The hypothesis of the study is that the practical use of this scale specific to alternating hemiplegia is reproducible. To this end, all the items on the scale will be scored independently for each patient by 4 neuropediatricians with expertise in the disease, in order to observe the reproducibility of the results obtained with this scale. The scale will be used for twenty AHC patients of all ages.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with alternating hemiplegia | – | Other: interview with neurologistPatients with alternating hemiplegia, from 0 to 99 years old |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients likely to participate in the study will be identified within the ESEFNP Department - Clinical Epileptology, Sleep Disorders, Functional Child Neurology, Hôpital Femme Mère Enfant, (HCL) as part of their regular medical follow-up. 20 AHC patients will be included in this study.
Key inclusion criteria (6 listed)
- Patient with confirmed diagnosis of AHC, unrestricted age range 0-99 years
- At least one parent and/or legal guardian who understands and speaks the national language
- Gathering of the non-opposition of the patient and/or his legal representative
- Collection of non-opposition from parents/guardians
Key exclusion criteria (2 listed)
- Patient's refusal to participate in the study
- Patient under court protection, unable to give 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 |
|---|---|---|
| interview with neurologistinterview with neurologist | Other | Patients with alternating hemiplegia |
Primary outcome
Composite primary endpoint : - missing data from the scale <5 - mean scores compared between the 4 neurologists are close to the scale's mid-point, i.e. floor and ceiling effects are < 20%, and skewness statistics are between 21 and 11
Time frame: At inclusion
All statistical tests will be performed using SPSS version 24.0 statistical software, and P < 0.05 will be considered significant. Validation of the use of the scale based on the results obtained independently by the 4 expert neurologists using a composite primary endpoint consisting of three criteria: * missing data from the scale <5 * mean scores compared between the 4 neurologists are close to the scale's mid-point, i.e. floor and ceiling effects are < 20%, and skewness statistics are between 21 and 11.
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Alternating Hemiplegia, run by Hospices Civils de Lyon 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 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: finished, as of the sponsor's last update on 27 Feb 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?
Composite primary endpoint : - missing data from the scale <5 - mean scores compared between the 4 neurologists are close to the scale's mid-point, i.e. floor and ceiling effects are < 20%, and skewness statistics are between 21 and 11 (time frame: At inclusion). 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 27 Feb 2025.