Studying Non-motor Symptoms in HSP

Completed

• Conditions: SPG4
• Interventions: Diagnostic Test: EuroQol five dimensions questionaire (EQ-5D); Diagnostic Test: Modified Fatigue Impact Scale (MFI); Diagnostic Test: Brief Pain Inventory (BPI); Diagnostic Test: Becks Depression Inventory (BDI); Diagnostic Test: Restless-leg Questionaire (RLS diagnostic criteria)

• Registration Number: NCT03204773
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

Comparing the non-motor symptoms of patients with hereditary spastic paraplegia (HSP) to healthy controls (spouses, relatives or other healthy controls) by using the a number of specific questionaires

Detailed Description

https://lamapoll.de/NMS_in_HSP

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Study Start: 2018-04-28
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Group 1: Patients with HSP (hereditary spastic paraplegia)
• Group 2: Healthy controls
• Age 18 to 70 years
• Written, informed consent

Exclusion Criteria

• Lack of ability for a written, informed consent
• Presence of spastic gait disorder or other neurological condition (Group 2)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Becks Depression Inventory (BDI)	healthy controls (spouses, relatives, or other healthy controls)
HSP patients	Restless-leg Questionaire (RLS diagnostic criteria)	Patients with hereditary spastic paraplegia regardless of their genetic mutation
HSP patients	Modified Fatigue Impact Scale (MFI)	Patients with hereditary spastic paraplegia regardless of their genetic mutation
Healthy controls	EuroQol five dimensions questionaire (EQ-5D)	healthy controls (spouses, relatives, or other healthy controls)
HSP patients	EuroQol five dimensions questionaire (EQ-5D)	Patients with hereditary spastic paraplegia regardless of their genetic mutation
Healthy controls	Restless-leg Questionaire (RLS diagnostic criteria)	healthy controls (spouses, relatives, or other healthy controls)
HSP patients	Brief Pain Inventory (BPI)	Patients with hereditary spastic paraplegia regardless of their genetic mutation
HSP patients	Becks Depression Inventory (BDI)	Patients with hereditary spastic paraplegia regardless of their genetic mutation
Healthy controls	Modified Fatigue Impact Scale (MFI)	healthy controls (spouses, relatives, or other healthy controls)
Healthy controls	Brief Pain Inventory (BPI)	healthy controls (spouses, relatives, or other healthy controls)

Primary Outcome Measures

Name	Time	Method
Identification of relevant non-motor symptoms in SPG4	day 1	By using the five mentioned scales we try to identify relevant non-motor symptoms

Trial Locations

Locations (1)

University Hospital Tübingen, Center for Neurology; 🇩🇪 Tübingen, Germany