Studying Cognition in SPG4

NCT03104088 | Completed

• 1 other identifier: Cognition_SPG4
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Impairment; Hereditary Spastic Paraplegia

Outcome Measures

Primary Outcomes (1)

• Identifying cognitive affected domains by using CANTAB

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

  day 1

Study Arms (2)

SPG4 patients

Diagnostic Test: CANTAB; Diagnostic Test: MOCA

Healthy controls

Diagnostic Test: CANTAB; Diagnostic Test: MOCA

Interventions

CANTAB DIAGNOSTIC_TEST

CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)

Healthy controls; SPG4 patients

MOCA DIAGNOSTIC_TEST

Montreal cognitive assessment (MOCA) in German

Healthy controls; SPG4 patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

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: 31646384 RESULT

Related Links

• Article Link (DOI)

MeSH Terms

Conditions

Cognitive Dysfunction; Spastic Paraplegia, Hereditary

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Ludger Schöls, Prof. Dr.

  University Hospital Tübingen, Center for Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 7, 2017
• Study Start: May 10, 2017
• Primary Completion: December 24, 2017
• Study Completion: December 24, 2017
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)