Studying Cognition in SPG4 Compared to Healthy Controls

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Prof. Dr. Ludger Schöls, University Hospital Tuebingen
Sponsor:
University Hospital Tuebingen
Information provided by (Responsible Party):
Prof. Dr. Ludger Schöls, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT03104088
First received: March 23, 2017
Last updated: May 10, 2017
Last verified: May 2017
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
Comparing the cognitive levels of patients with SPG4 mutations to healthy controls.

Condition Intervention
Cognitive Impairment
Hereditary Spastic Paraplegia
Diagnostic Test: CANTAB
Diagnostic Test: MOCA

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Studying Cognition in SPG4 Compared to Healthy Controls

Resource links provided by NLM:

Genetics Home Reference related topics: Silver syndrome Troyer syndrome infantile-onset ascending hereditary spastic paralysis spastic paraplegia type 11 spastic paraplegia type 15 spastic paraplegia type 2 spastic paraplegia type 31 spastic paraplegia type 3A spastic paraplegia type 4 spastic paraplegia type 7 spastic paraplegia type 8
Genetic and Rare Diseases Information Center resources: Paraplegia Hereditary Spastic Paraplegia Infantile-onset Ascending Hereditary Spastic Paralysis Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsy Roussy Levy Syndrome
U.S. FDA Resources

Further study details as provided by Prof. Dr. Ludger Schöls, University Hospital Tuebingen:

Primary Outcome Measures:
Identifying cognitive affected domains by using CANTAB [ Time Frame: day 1 ]
Number of SPG4 patients with affections in the examined cognitive domains by using CANTAB

Estimated Enrollment: 50
Actual Study Start Date: May 10, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SPG4 patients Diagnostic Test: CANTAB
CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)
Diagnostic Test: MOCA
Montreal cognitive assessment (MOCA) in German
Healthy controls Diagnostic Test: CANTAB
CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)
Diagnostic Test: MOCA
Montreal cognitive assessment (MOCA) in German

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

Ages Eligible for Study: 18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study: 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).
Criteria
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03104088

Contacts
Contact: Ludger Schöls, Prof. Dr. +49-(0)7071-2982057 ludger.schoels@uni-tuebingen.de

Locations
Germany
University Hospital Tübingen, Center for Neurology Recruiting
Tubingen, Germany, 72076
Contact: Ludger Schöls, MD
Sub-Investigator: Tim W. Rattay, MD
Sub-Investigator: Sarah Wiethoff, MD
Sub-Investigator: Holger Hengel, MD
Sub-Investigator: Rebecca Schüle, MD
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Ludger Schöls, Prof. Dr. University Hospital Tübingen, Center for Neurology
More Information

Responsible Party: Prof. Dr. Ludger Schöls, Prinicipal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03104088 History of Changes
Other Study ID Numbers: Cognition_SPG4
Study First Received: March 23, 2017
Last Updated: May 10, 2017
Individual Participant Data
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Paraplegia
Spastic Paraplegia, Hereditary
Hereditary Sensory and Motor Neuropathy
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn