Studying Cognition in SPG4

Studying Cognition in SPG4 Compared to Healthy Controls

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

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Hereditary Spastic Paraplegia
• Intervention / Treatment: Diagnostic test: CANTAB; Diagnostic test: MOCA

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • Tubingen, Germany, 72076
    • University Hospital Tübingen, Center for Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls	Diagnostic test: CANTAB; CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG); Diagnostic test: MOCA; Montreal cognitive assessment (MOCA) in German
SPG4 patients	Diagnostic test: CANTAB; CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG); Diagnostic test: MOCA; Montreal cognitive assessment (MOCA) in German

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying cognitive affected domains by using CANTAB	Number of SPG4 patients with affections in the examined cognitive domains by using CANTAB	day 1

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Ludger Schöls, Prof. Dr., University Hospital Tübingen, Center for Neurology

Publications and helpful links

General 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.

Helpful Links

• Article Link (DOI)

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): December 24, 2017
• Study Completion (Actual): December 24, 2017

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Paralysis; Polyneuropathies; Hereditary Sensory and Motor Neuropathy; Paraplegia; Spastic Paraplegia, Hereditary
• Other Study ID Numbers: Cognition_SPG4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No