Back to resultsA Study Exploring Brain Activity in Relation to Sensory Arm Impairments in the Early Stages of Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Electroencephalography
Sponsored by
About this trial
This is an interventional basic science trial for Stroke focused on measuring upper limb, recovery, somatosensory, impairment, electroencephalography, acute phase
Eligibility Criteria
Participants will be recruited during the first 2-3 days post-stroke. They should have:
- a first-ever unilateral, supra-tentorial stroke, as defined by Wold Health Organisation;
- admission to the acute hospital,
- 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),
- the age of > 18 years and
- the ability to provide informed consent.
Healthy adults will also be recruited and they should have:
- no history of sensory impairments in their hands
- the age of > 18 years and
- the ability to provide informed consent.
Sites / Locations
- Saint Luc Hospital
Outcomes
Primary Outcome Measures
Sensory Evoked Potential Latency
EEG measurement
Sensory Evoked Potential Amplitude
EEG measurement
Secondary Outcome Measures
Fugl Meyer Assessment
Upper limb motor impairment measurement
Wolf Motor Function Test
Upper limb activities measurement
Perceptual Threshold of Touch
Light touch of the palmar surface of index finger
Erasmus modified Nottingham Sensory Assessment
Measures somatosensation of the upper limb and hand
Nottingham Sensory Assessment
Measures stereognosis
Montreal Cognitive Assessment
Measures cognition
Full Information
NCT ID
NCT03407547
First Posted
January 8, 2018
Last Updated
October 30, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03407547
Brief Title
A Study Exploring Brain Activity in Relation to Sensory Arm Impairments in the Early Stages of Stroke
Official Title
Neural Correlates of Upper Limb Somatosensory Impairments and Recovery in the Acute Phase After Stroke: an EEG Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
upper limb, recovery, somatosensory, impairment, electroencephalography, acute phase
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Electroencephalography
Intervention Description
EEG is a device to measure brain activity via surface electrodes
Primary Outcome Measure Information:
Title
Sensory Evoked Potential Latency
Description
EEG measurement
Time Frame
First 2 weeks post-stroke
Title
Sensory Evoked Potential Amplitude
Description
EEG measurement
Time Frame
First 2 weeks post-stroke
Secondary Outcome Measure Information:
Title
Fugl Meyer Assessment
Description
Upper limb motor impairment measurement
Time Frame
First 2 weeks post-stroke
Title
Wolf Motor Function Test
Description
Upper limb activities measurement
Time Frame
First 2 weeks post-stroke
Title
Perceptual Threshold of Touch
Description
Light touch of the palmar surface of index finger
Time Frame
First 2 weeks post-stroke
Title
Erasmus modified Nottingham Sensory Assessment
Description
Measures somatosensation of the upper limb and hand
Time Frame
First 2 weeks post-stroke
Title
Nottingham Sensory Assessment
Description
Measures stereognosis
Time Frame
First 2 weeks post-stroke
Title
Montreal Cognitive Assessment
Description
Measures cognition
Time Frame
First 2 weeks post-stroke
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participants will be recruited during the first 2-3 days post-stroke. They should have:
a first-ever unilateral, supra-tentorial stroke, as defined by Wold Health Organisation;
admission to the acute hospital,
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),
the age of > 18 years and
the ability to provide informed consent.
Healthy adults will also be recruited and they should have:
no history of sensory impairments in their hands
the age of > 18 years and
the ability to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Tedesco Triccas, PhD
Phone
+32 491256369
Email
lisa.tedescotriccas@kukeuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Geert Verheyden, PhD
Phone
+32 16329116
Email
geert.verheyden@kuleuven.be
Facility Information:
Facility Name
Saint Luc Hospital
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Peeters, MD
Phone
+32 2 764 1082
Email
andre.peeters@uclouvain.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Exploring Brain Activity in Relation to Sensory Arm Impairments in the Early Stages of Stroke
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