Studying Non-motor Symptoms in HSP

SPG4 Clinical Trial

Official title:

Studying Non-motor Symptoms in Patients With Hereditary Spastic Paraplegia (HSP) Compared to Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204773
• Other study ID #: NMS in HSP
• Status: Completed
• Start date: April 28, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

https://lamapoll.de/NMS_in_HSP

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: July 30, 2019
• Est. primary completion date: July 1, 2019
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• SPG4

Intervention

Diagnostic Test:
• EuroQol five dimensions questionaire (EQ-5D)
Testing quality of life.
• Modified Fatigue Impact Scale (MFI)
Screening for fatigue
• Brief Pain Inventory (BPI)
Testing for pain
• Becks Depression Inventory (BDI)
Screening for depression
• Restless-leg Questionaire (RLS diagnostic criteria)
Testing for restless-legs

Locations

Country	Name	City	State
Germany	University Hospital Tübingen, Center for Neurology	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Rattay TW, Boldt A, Völker M, Wiethoff S, Hengel H, Schüle R, Schöls L. Non-motor symptoms are relevant and possibly treatable in hereditary spastic paraplegia type 4 (SPG4). J Neurol. 2020 Feb;267(2):369-379. doi: 10.1007/s00415-019-09573-w. Epub 2019 Oc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of relevant non-motor symptoms in SPG4	By using the five mentioned scales we try to identify relevant non-motor symptoms	day 1

External Links

•   Link Citation (DOI)