Studying Non-motor Symptoms in HSP

August 25, 2020 updated by: Dr. Tim W. Rattay, University Hospital Tuebingen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

https://lamapoll.de/NMS_in_HSP

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • University Hospital Tübingen, Center for Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We recruit known patients to our department or via patient interest groups.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HSP patients
Patients with hereditary spastic paraplegia regardless of their genetic mutation
Diagnostic test: EuroQol five dimensions questionaire (EQ-5D)
Testing quality of life.
Diagnostic test: Modified Fatigue Impact Scale (MFI)
Screening for fatigue
Diagnostic test: Brief Pain Inventory (BPI)
Testing for pain
Diagnostic test: Becks Depression Inventory (BDI)
Screening for depression
Diagnostic test: Restless-leg Questionaire (RLS diagnostic criteria)
Testing for restless-legs
Healthy controls
healthy controls (spouses, relatives, or other healthy controls)
Diagnostic test: EuroQol five dimensions questionaire (EQ-5D)
Testing quality of life.
Diagnostic test: Modified Fatigue Impact Scale (MFI)
Screening for fatigue
Diagnostic test: Brief Pain Inventory (BPI)
Testing for pain
Diagnostic test: Becks Depression Inventory (BDI)
Screening for depression
Diagnostic test: Restless-leg Questionaire (RLS diagnostic criteria)
Testing for restless-legs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Tim W. Rattay, MD, Researcher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • NMS in HSP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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