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NCT03104088 Clinical Trial

Studying Cognition in SPG4

Cognitive Impairment Clinical Trial

Official title:
Studying Cognition in SPG4 Compared to Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03104088
Other study ID # Cognition_SPG4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2017
Est. completion date December 24, 2017

Study information
Verified date August 2020
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 24, 2017
Est. primary completion date December 24, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patient with SPG4 with known SPAST-Mutation (patient group) or healthy control

- Age 18 to 70 years

- Written, informed consent

Exclusion Criteria:

- Lack of ability for a written, informed consent

- Presence of gait disorder or other neurological condition (for healthy controls)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• CANTAB
CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)
• MOCA
Montreal cognitive assessment (MOCA) in German

Locations
Country Name City State
Germany University Hospital Tübingen, Center for Neurology Tubingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Rattay TW, Boldt A, Völker M, Wiethoff S, Hengel H, Schüle R, Schöls 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 Oc — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Identifying cognitive affected domains by using CANTAB Number of SPG4 patients with affections in the examined cognitive domains by using CANTAB day 1
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