Hereditary Spastic ParaplegiaMODIFSPA2NCT05373082
Identification of Modifying Factors in Hereditary Spastic Paraplegia
An observational study of Hereditary Spastic Paraplegia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A first questionnaire - MODIFSPA conducted in 2014 - identified several environmental factors influencing spasticity in HSP: cold, fatigue, and especially physical activity. In order to improve the care of patients with HSP, The investigator team are looking to deepen the knowledge on physical exercises relieving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Spastic Paraplegia
- What is being tested?
- questionnaire completion
- How many people
- 311 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2022to 3 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Hereditary Spastic Paraplegia (HSP)
Who may be able to join
- French-speaking adult patients aware of their PSH diagnosis coming to the genetic consultation at the Pitié-Salpêtrière Hospital or informed via an association / website of the BRAINTEAM study network
- Affiliated with social security
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
A first questionnaire - MODIFSPA conducted in 2014 - identified several environmental factors influencing spasticity in HSP: cold, fatigue, and especially physical activity. In order to improve the care of patients with HSP, The investigator team are looking to deepen the knowledge on physical exercises relieving spasticity as well as to better know the frequency of symptoms requiring additional medical care: fatigue and vesico-sphincter disorders. A new questionnaire was therefore created to collect additional information to optimize the care of patients with HSP.
Read the detailed description
The only common symptom of hereditary spastic paraplegia (HSP) is the presence of spasticity in the lower limbs, associated with a great clinical and genetic heterogeneity.
A first MODIFSPA study carried out by the team identified environmental factors influencing spasticity: stress, fatigue, physical activity. In this first study, only spasticity was studied but several symptoms appeared to require medical management according to the patients: fatigue and vesico-sphincter disorders.
Following this first study, MODIFSPA2 aims to deepen our knowledge of HSP, via the expertise of patients, to propose a care in adequacy with their needs/demands.
Validated scales are included in the questionnaire to evaluate the frequency and intensity of the symptoms most reported by patients (fatigue, pain and mood disorders). Questions are asked to better know the frequency of symptoms requiring additional medical care: fatigue and vesico-sphincter disorders.
- Conditions
- Hereditary Spastic Paraplegia
- Being tested
- questionnaire completion
- Medical subject headings
- Spastic Paraplegia, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire completionOther
Questionnaire to be completed by patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with hereditary spastic Paraplegia | Patients with hereditary spastic Paraplegia Receives: Other: questionnaire completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
factors influencing spasticity
Temperature,stress, anxiety , intercurrent infection, physical activities and tiredness are the factors influencing spasticity (common symptom of all these patients): Only questions are asked with yes and no answers
Measured: 1 day
Secondary outcomes (3)
Physical activities
Does physical activity improve your health?
Measured: 1 day
Symptoms
what symptoms do you have? fatigue, pain and vesico-sphincter disorders ( answers are yes or not)
Measured: 1 day
Anxiety
Determine anxiety or depressive disorders (Hospital Anxiety and Depression scale; HAD) in this population anxiety max score>11 ( minimal anxiety score<7)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start4 Oct 2022
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Spastic ParaplegiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373082
- Sponsor's protocol ID
- APHP211621
- Acronym
- MODIFSPA2
- Status last verified
- Oct 2023
- First submitted
- 4 Mar 2022
- Last updated
- 31 Oct 2023
- 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 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Modifying Factors in Hereditary Spastic Paraplegia
- ClinicalTrials.gov ID
- NCT05373082
- Acronym / sponsor ID
- MODIFSPA2 / APHP211621
- Conditions
- Hereditary Spastic Paraplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 13 May 2022 (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.
A first questionnaire - MODIFSPA conducted in 2014 - identified several environmental factors influencing spasticity in HSP: cold, fatigue, and especially physical activity. In order to improve the care of patients with HSP, The investigator team are looking to deepen the knowledge on physical exercises relieving spasticity as well as to better know the frequency of symptoms requiring additional medical care: fatigue and vesico-sphincter disorders. A new questionnaire was therefore created to collect additional information to optimize the care of patients with HSP.
Detailed description
The only common symptom of hereditary spastic paraplegia (HSP) is the presence of spasticity in the lower limbs, associated with a great clinical and genetic heterogeneity.
A first MODIFSPA study carried out by the team identified environmental factors influencing spasticity: stress, fatigue, physical activity. In this first study, only spasticity was studied but several symptoms appeared to require medical management according to the patients: fatigue and vesico-sphincter disorders.
Following this first study, MODIFSPA2 aims to deepen our knowledge of HSP, via the expertise of patients, to propose a care in adequacy with their needs/demands.
Validated scales are included in the questionnaire to evaluate the frequency and intensity of the symptoms most reported by patients (fatigue, pain and mood disorders). Questions are asked to better know the frequency of symptoms requiring additional medical care: fatigue and vesico-sphincter disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hereditary spastic Paraplegia | – | Other: questionnaire completionPatients with hereditary spastic Paraplegia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Hereditary Spastic Paraplegia (HSP)
Key inclusion criteria (2 listed)
- French-speaking adult patients aware of their PSH diagnosis coming to the genetic consultation at the Pitié-Salpêtrière Hospital or informed via an association / website of the BRAINTEAM study network
- Affiliated with social security
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| questionnaire completionQuestionnaire to be completed by patients | Other | Patients with hereditary spastic Paraplegia |
Primary outcome
factors influencing spasticity
Time frame: 1 day
Temperature,stress, anxiety , intercurrent infection, physical activities and tiredness are the factors influencing spasticity (common symptom of all these patients): Only questions are asked with yes and no answers
3 secondary outcomes
Physical activities
Time frame: 1 day
Symptoms
Time frame: 1 day
Anxiety
Time frame: 1 day
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 31 Oct 2023.
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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 Hereditary Spastic Paraplegia, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 1 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 31 Oct 2023. 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?
factors influencing spasticity (time frame: 1 day). 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 31 Oct 2023.