Studying Cognition in SPG4 | NCT03104088

Studies
Studying Cognition in SPG4

NCT03104088

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Aug 28, 2020Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Cognitive Impairment
Hereditary Spastic Paraplegia

Interventions

CANTAB
MOCA

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2017Actual

Primary Completion Date

Dec 24, 2017Actual

Completion Date

Dec 24, 2017Actual

First Submitted Date

Mar 23, 2017

First Submission Date that Met QC Criteria

Mar 31, 2017

First Posted Date

Apr 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2020

Last Update Posted Date

Aug 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. Ludger Schöls, Prinicipal Investigator, University Hospital TuebingenPrincipal Investigator

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPG4 patients			Diagnostic Test: CANTAB Diagnostic Test: MOCA
Healthy controls			Diagnostic Test: CANTAB Diagnostic Test: MOCA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CANTAB	Diagnostic Test	CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)	Healthy controls SPG4 patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ludger Schöls, Prof. Dr.	University Hospital Tübingen, Center for Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tübingen, Center for Neurology		Tübingen		72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31646384	Result	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.

ID	Term
D060825	Cognitive Dysfunction
D015419	Spastic Paraplegia, Hereditary

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D015417	Hereditary Sensory and Motor Neuropathy