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OpenTrials
Completed

NCT Number: NCT03204773

Studying Non-motor Symptoms in HSP

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

Completed

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Key information

Conditions

SPG4

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tübingen, Center for Neurology

Tübingen, 72076, Germany

About this study

https://lamapoll.de/NMS_in_HSP

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EuroQol five dimensions questionaire (EQ-5D)

Diagnostic Test

Testing quality of life.

Modified Fatigue Impact Scale (MFI)

Diagnostic Test

Screening for fatigue

Brief Pain Inventory (BPI)

Diagnostic Test

Testing for pain

Becks Depression Inventory (BDI)

Diagnostic Test

Screening for depression

Restless-leg Questionaire (RLS diagnostic criteria)

Diagnostic Test

Testing for restless-legs

Primary outcomes

  1. Identification of relevant non-motor symptoms in SPG4

    Time frame: day 1

    By using the five mentioned scales we try to identify relevant non-motor symptoms

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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