A Study Exploring Brain Activity in Relation to Sensory Arm Impairments in the Early Stages of Stroke

NCT ID: NCT03407547

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2025-12-31

Brief Summary

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This clinical study is organized for people with stroke often experience difficulties with their sensation in their upper limb. New technologies may be able to help these important problems. However, there is currently not enough knowledge about how the brain recovers in people with sensory impairments in their arm and hand. Using a non-invasive technique of recording brain activity, known as electroencephalography (EEG), brain activity in combination with somatosensation of the hand will be measured. Therefore, the purpose of this study will be to analyse brain activity in relation to somatosensory impairments after stroke during the first two weeks after stroke.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Electroencephalography

EEG is a device to measure brain activity via surface electrodes

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Participants will be recruited during the first 2-3 days post-stroke. They should have:

1. a first-ever unilateral, supra-tentorial stroke, as defined by Wold Health Organisation;
2. admission to the acute hospital,
3. deficit in distal pinprick somatosensory measured by Rivermead assessment of somatosensory performance (score of ≤4) and/or motor impairment measured by Fugl Meyer Assessment (score of ≤12 out of 14),
4. the age of \> 18 years and
5. the ability to provide informed consent.

Healthy adults will also be recruited and they should have:

1. no history of sensory impairments in their hands
2. the age of \> 18 years and
3. the ability to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint Luc Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S61174

Identifier Type: -

Identifier Source: org_study_id

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