Studying Non-motor Symptoms in HSP

NCT ID: NCT03204773

Last Updated: 2020-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-28

Study Completion Date

2019-07-30

Brief Summary

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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

Detailed Description

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https://lamapoll.de/NMS\_in\_HSP

Conditions

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SPG4

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HSP patients

Patients with hereditary spastic paraplegia regardless of their genetic mutation

EuroQol five dimensions questionaire (EQ-5D)

Intervention Type DIAGNOSTIC_TEST

Testing quality of life.

Modified Fatigue Impact Scale (MFI)

Intervention Type DIAGNOSTIC_TEST

Screening for fatigue

Brief Pain Inventory (BPI)

Intervention Type DIAGNOSTIC_TEST

Testing for pain

Becks Depression Inventory (BDI)

Intervention Type DIAGNOSTIC_TEST

Screening for depression

Restless-leg Questionaire (RLS diagnostic criteria)

Intervention Type DIAGNOSTIC_TEST

Testing for restless-legs

Healthy controls

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

EuroQol five dimensions questionaire (EQ-5D)

Intervention Type DIAGNOSTIC_TEST

Testing quality of life.

Modified Fatigue Impact Scale (MFI)

Intervention Type DIAGNOSTIC_TEST

Screening for fatigue

Brief Pain Inventory (BPI)

Intervention Type DIAGNOSTIC_TEST

Testing for pain

Becks Depression Inventory (BDI)

Intervention Type DIAGNOSTIC_TEST

Screening for depression

Restless-leg Questionaire (RLS diagnostic criteria)

Intervention Type DIAGNOSTIC_TEST

Testing for restless-legs

Interventions

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EuroQol five dimensions questionaire (EQ-5D)

Testing quality of life.

Intervention Type DIAGNOSTIC_TEST

Modified Fatigue Impact Scale (MFI)

Screening for fatigue

Intervention Type DIAGNOSTIC_TEST

Brief Pain Inventory (BPI)

Testing for pain

Intervention Type DIAGNOSTIC_TEST

Becks Depression Inventory (BDI)

Screening for depression

Intervention Type DIAGNOSTIC_TEST

Restless-leg Questionaire (RLS diagnostic criteria)

Testing for restless-legs

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Tim W. Rattay

Assistant doctor and postdoctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tim W. Rattay, MD

Role: PRINCIPAL_INVESTIGATOR

Researcher

Locations

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University Hospital Tübingen, Center for Neurology

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 31646384 (View on PubMed)

Related Links

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Other Identifiers

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NMS in HSP

Identifier Type: -

Identifier Source: org_study_id

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