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Studying Non-motor Symptoms in SPG4

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ClinicalTrials.gov Identifier: NCT03204773
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Tim W. Rattay, University Hospital Tuebingen

Brief Summary:
Comparing the non-motor symptoms of patients with SPG4 mutations to healthy controls (spouses, relatives or other healthy controls) by using the a number of specific questionaires

Condition or disease Intervention/treatment
SPG4 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)

Detailed Description:
https://lamapoll.de/NMS_in_HSP

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Studying Non-motor Symptoms in Patients With Hereditary Spastic Paraplegia (HSP) Type 4 (SPG4) Compared to Healthy Controls
Actual Study Start Date : April 28, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019


Group/Cohort Intervention/treatment
SPG4 patients
Patients with confirmed mutations in the SPG4 (SPAST) gene
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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
We recruit known patients to our department or via patient interest groups.
Criteria

Inclusion Criteria:

  • Group 1: Patient with SPG4 with known SPAST-Mutation
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204773


Contacts
Contact: Tim W. Rattay, MD +49-(0)7071-29 85247 tim.rattay@uni-tuebingen.de

Locations
Germany
University Hospital Tübingen, Center for Neurology Recruiting
Tübingen, Germany, 72076
Contact: Tim W. Rattay, MD    +49 7071 29 85247    tim.rattay@uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Tim W. Rattay, MD Researcher

Responsible Party: Dr. Tim W. Rattay, Assistant doctor and postdoctoral researcher, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03204773     History of Changes
Other Study ID Numbers: NMS in SPG4
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No