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Studying Non-motor Symptoms in SPG4

Sponsor:
University Hospital Tuebingen
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)

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
Anticipated Study Start Date : December 2017
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

Ages Eligible for Study: 18 Years to 70 Years (Adult, Senior)
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)
Contacts and Locations
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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