Identification of Modifying Factors in Hereditary Spastic Paraplegia

Hereditary Spastic Paraplegia Clinical Trial

— MODIFSPA2  

Official title:

Identification of Modifying Factors in Hereditary Spastic Paraplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05373082
• Other study ID #: APHP211621
• Status: Completed
• Start date: October 4, 2022
• Est. completion date: October 3, 2023

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: October 3, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• NA

Related Conditions & MeSH terms

• Hereditary Spastic Paraplegia
• Muscle Spasticity
• Paraplegia
• Spastic Paraplegia, Hereditary

Intervention

Other:
• questionnaire completion
Questionnaire to be completed by patients

Locations

Country	Name	City	State
France	Institut du Cerveau, ICM	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physical activities	Does physical activity improve your health?	1 day
Secondary	Symptoms	what symptoms do you have? fatigue, pain and vesico-sphincter disorders ( answers are yes or not)	1 day
Secondary	Anxiety	Determine anxiety or depressive disorders (Hospital Anxiety and Depression scale; HAD) in this population anxiety max score>11 ( minimal anxiety score<7)	1 day