NCT03204773

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

April 28, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

June 26, 2017

Last Update Submit

August 25, 2020

Conditions

SPG4

Outcome Measures

Primary Outcomes (1)

  • Identification of relevant non-motor symptoms in SPG4

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

    day 1

Study Arms (2)

HSP patients

Patients with hereditary spastic paraplegia regardless of their genetic mutation

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)

Healthy controls

healthy controls (spouses, relatives, or other healthy controls)

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)

Interventions

EuroQol five dimensions questionaire (EQ-5D)DIAGNOSTIC_TEST

Testing quality of life.

HSP patientsHealthy controls
Modified Fatigue Impact Scale (MFI)DIAGNOSTIC_TEST

Screening for fatigue

HSP patientsHealthy controls
Brief Pain Inventory (BPI)DIAGNOSTIC_TEST

Testing for pain

HSP patientsHealthy controls
Becks Depression Inventory (BDI)DIAGNOSTIC_TEST

Screening for depression

HSP patientsHealthy controls
Restless-leg Questionaire (RLS diagnostic criteria)DIAGNOSTIC_TEST

Testing for restless-legs

HSP patientsHealthy controls

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Group 1: Patients with HSP (hereditary spastic paraplegia)
  • Group 2: Healthy controls
  • Age 18 to 70 years
  • Written, informed consent

You may not qualify if:

  • Lack of ability for a written, informed consent
  • Presence of spastic gait disorder or other neurological condition (Group 2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen, Center for Neurology

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Rattay TW, Boldt A, Volker M, Wiethoff S, Hengel H, Schule R, Schols 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 Oct 23.

    PMID: 31646384RESULT

Related Links

Study Officials

  • Tim W. Rattay, MD

    Researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant doctor and postdoctoral researcher

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 2, 2017

Study Start

April 28, 2018

Primary Completion

July 1, 2019

Study Completion

July 30, 2019

Last Updated

August 27, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)