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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03407547
• Other study ID #: S61174
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Lisa Tedesco Triccas, PhD
• Phone: +32 491256369
• Email: lisa.tedescotriccas[@]kukeuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Diagnostic Test:
• Electroencephalography
EEG is a device to measure brain activity via surface electrodes

Locations

Country	Name	City	State
Belgium	Saint Luc Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory Evoked Potential Latency	EEG measurement	First 2 weeks post-stroke
Primary	Sensory Evoked Potential Amplitude	EEG measurement	First 2 weeks post-stroke
Secondary	Fugl Meyer Assessment	Upper limb motor impairment measurement	First 2 weeks post-stroke
Secondary	Wolf Motor Function Test	Upper limb activities measurement	First 2 weeks post-stroke
Secondary	Perceptual Threshold of Touch	Light touch of the palmar surface of index finger	First 2 weeks post-stroke
Secondary	Erasmus modified Nottingham Sensory Assessment	Measures somatosensation of the upper limb and hand	First 2 weeks post-stroke
Secondary	Nottingham Sensory Assessment	Measures stereognosis	First 2 weeks post-stroke
Secondary	Montreal Cognitive Assessment	Measures cognition	First 2 weeks post-stroke