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Trial record 6 of 16 for:    "spastic paraplegia type 11" OR "Spastic Paraplegia, Hereditary" OR "Spastic Paraplegia"

Studying Cognition in SPG4

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ClinicalTrials.gov Identifier: NCT03104088
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Ludger Schöls, University Hospital Tuebingen

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

Condition or disease Intervention/treatment
Cognitive Impairment Hereditary Spastic Paraplegia 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
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Studying Cognition in SPG4 Compared to Healthy Controls
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : December 24, 2017
Actual Study Completion Date : December 24, 2017


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104088


Locations
Germany
University Hospital Tübingen, Center for Neurology
Tubingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Ludger Schöls, Prof. Dr. University Hospital Tübingen, Center for Neurology

Responsible Party: Prof. Dr. Ludger Schöls, Prinicipal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03104088     History of Changes
Other Study ID Numbers: Cognition_SPG4
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Spastic Paraplegia, Hereditary
Cognitive Dysfunction
Paraplegia
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hereditary Sensory and Motor Neuropathy
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn