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CompletedNCT03104088Updated Aug 28, 2020

Studying Cognition in SPG4

An observational study in Cognitive Impairment and Hereditary Spastic Paraplegia, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-28.

Sponsored by University Hospital Tuebingen · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Comparing the cognitive levels of patients with SPG4 mutations to healthy controls.

Read the detailed description

Comparing the cognitive levels of patients with SPG4 mutations to healthy controls by using the CANTAB® and MoCA.

02

Conditions studied

  • Cognitive Impairment
  • Hereditary Spastic Paraplegia
03

In context

Paraplegia

150 studies on the registry are indexed under Paraplegia; 43 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 42 observational studies indexed under Paraplegia.

Browse Paraplegia studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Probands will be recruited at the HSP Outpatient Clinic of the Department of Neurology in Tübingen. Eligible participants are age 18 to 70 years of age. Group 1 include p: patients with genetically confirmed SPG4 (group 1) and manifest disease with spastic gait disorder. Group 2 includes age- and sex-matched and healthy controls (spouses, other relatives or further healthy controls) with an educational level comparable to group 1 (group 2).

Inclusion criteria

  • Patient with SPG4 with known SPAST-Mutation (patient group) or healthy control
  • Age 18 to 70 years
  • Written, informed consent

Exclusion criteria

Exclusion Criteria:

  • Lack of ability for a written, informed consent
  • Presence of gait disorder or other neurological condition (for healthy controls)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • SPG4 patients

    Diagnostic Test: CANTAB · Diagnostic Test: MOCA

  • Healthy controls

    Diagnostic Test: CANTAB · Diagnostic Test: MOCA

Interventions

  • Diagnostic testCANTAB

    CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)

  • Diagnostic testMOCA

    Montreal cognitive assessment (MOCA) in German

06

What researchers measure

Primary outcomes

  1. Identifying cognitive affected domains by using CANTAB

    Number of SPG4 patients with affections in the examined cognitive domains by using CANTAB

    Time frame: day 1

07

Study locations

1 site
  • University Hospital Tübingen, Center for Neurology
    Tubingen, 72076, Germany
08

References and documents

Publications

  • 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. PubMed 31646384 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03104088
Lead sponsor
University Hospital Tuebingen
Responsible party
Prof. Dr. Ludger Schöls (Prinicipal Investigator, University Hospital Tuebingen) — Principal investigator
First posted
Apr 7, 2017
Start date
May 10, 2017
Primary completion
Dec 24, 2017
Completion
Dec 24, 2017
Last update
Aug 28, 2020

Study contacts

Ludger Schöls, Prof. Dr.
principal investigator · University Hospital Tübingen, Center for Neurology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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