Identification of Modifying Factors in Hereditary Spastic... | NCT05373082

Studies
Identification of Modifying Factors in Hereditary Spastic Paraplegia

NCT05373082

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Oct 31, 2023Actual

Enrollment

311Actual

Phase

Not provided

Conditions

Hereditary Spastic Paraplegia

Interventions

questionnaire completion

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2022Actual

Primary Completion Date

Oct 3, 2023Actual

Completion Date

Oct 3, 2023Actual

First Submitted Date

Mar 4, 2022

First Submission Date that Met QC Criteria

May 9, 2022

First Posted Date

May 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2023

Last Update Posted Date

Oct 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

311Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with hereditary spastic Paraplegia		Patients with hereditary spastic Paraplegia	Other: questionnaire completion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire completion	Other	Questionnaire to be completed by patients	Patients with hereditary spastic Paraplegia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1 day

Secondary Outcomes

Measure	Description	Time Frame
Physical activities	Does physical activity improve your health?	1 day
Symptoms	what symptoms do you have? fatigue, pain and vesico-sphincter disorders ( answers are yes or not)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Hereditary Spastic Paraplegia (HSP)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut du Cerveau, ICM		Paris		75013	France

Condition Browse Module

MeSH Terms

ID	Term
D015419	Spastic Paraplegia, Hereditary

Ancestor Terms

ID	Term
D015417	Hereditary Sensory and Motor Neuropathy
D009421	Nervous System Malformations
D009422	Nervous System Diseases
D020271	Heredodegenerative Disorders, Nervous System

Browse Leaves

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Browse Branches

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