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

Neural Correlates of Upper Limb Somatosensory Impairments and Recovery in the Acute Phase After Stroke: an EEG Investigation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: Electroencephalography

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Saint Luc Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory Evoked Potential Latency	EEG measurement	First 2 weeks post-stroke
Sensory Evoked Potential Amplitude	EEG measurement	First 2 weeks post-stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Assessment	Upper limb motor impairment measurement	First 2 weeks post-stroke
Wolf Motor Function Test	Upper limb activities measurement	First 2 weeks post-stroke
Perceptual Threshold of Touch	Light touch of the palmar surface of index finger	First 2 weeks post-stroke
Erasmus modified Nottingham Sensory Assessment	Measures somatosensation of the upper limb and hand	First 2 weeks post-stroke
Nottingham Sensory Assessment	Measures stereognosis	First 2 weeks post-stroke
Montreal Cognitive Assessment	Measures cognition	First 2 weeks post-stroke

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: recovery; upper limb; electroencephalography; impairment; somatosensory; acute phase
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: S61174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No