Simultaneous Recording of Cognitive and Motor Functions A... | NCT05454748

Studies
Simultaneous Recording of Cognitive and Motor Functions After Stroke

NCT05454748

Sponsor

Centre Hospitalier St Anne

Status

Completed

Last Update Posted

Mar 1, 2024Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

France

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

Jun 2022

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

Feb 3, 2022Actual

Primary Completion Date

Jun 20, 2023Actual

Completion Date

Jun 20, 2023Actual

First Submitted Date

Jun 27, 2022

First Submission Date that Met QC Criteria

Jul 11, 2022

First Posted Date

Jul 12, 2022Actual

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

Feb 29, 2024

Last Update Posted Date

Mar 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Aim: To assess whether a cognitively demanding dual-task has greater impact on manual dexterity in chronic stroke patients than in healthy subjects.

Methods: A visuomotor force-tracking task, combining grip force and oculomotor recordings, will be applied in chronic stroke patients with mild-moderate hemiparesis without clinical cognitive impairments and in age-comparable healthy subjects. The dual-task includes avoiding visual distractors and mental addition of numbers. Dual-task effect is calculated as difference in force control accuracy (dual minus single-task) and as difference in saccade rate (addition of numbers minus visual distractors).

Detailed Description

Not provided

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

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Saccade inhibition rate	Cross sectional comparison of % of saccades performed towards visual distractors	Baseline measurement (one occasion)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years old
First symptomatic stroke more than 3 months ago
Box and blocks test score < 52
Mini Mental State Examination Test > 25

Exclusion Criteria:

Psychiatric disease
Risk of Pregnancy
History of previous stroke
Disability that may interfere with the performance of tasks

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stroke patients group and Age comparable healthy controls group

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41074170	Derived	Dziezuk E, Le Boterff Q, Van Ravestyn C, Mairesse S, Hamdoun S, Calvet D, Daghsen L, Carment L, Rosso C, Maier MA, Turc G, Mas JL, G Lindberg P. Divided attention and manual visuomotor control in stroke: a combined dual-task and eye movement study. J Neuroeng Rehabil. 2025 Oct 10;22(1):212. doi: 10.1186/s12984-025-01735-4.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases