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NCT Number: NCT03407547

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Luc Hospital

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroencephalography

Diagnostic Test

EEG is a device to measure brain activity via surface electrodes

Primary outcomes

  1. Sensory Evoked Potential Latency

    Time frame: First 2 weeks post-stroke

    EEG measurement

  2. Sensory Evoked Potential Amplitude

    Time frame: First 2 weeks post-stroke

    EEG measurement

Secondary outcomes

  1. Fugl Meyer Assessment

    Time frame: First 2 weeks post-stroke

    Upper limb motor impairment measurement

  2. Wolf Motor Function Test

    Time frame: First 2 weeks post-stroke

    Upper limb activities measurement

  3. Perceptual Threshold of Touch

    Time frame: First 2 weeks post-stroke

    Light touch of the palmar surface of index finger

  4. Erasmus modified Nottingham Sensory Assessment

    Time frame: First 2 weeks post-stroke

    Measures somatosensation of the upper limb and hand

  5. Nottingham Sensory Assessment

    Time frame: First 2 weeks post-stroke

    Measures stereognosis

  6. Montreal Cognitive Assessment

    Time frame: First 2 weeks post-stroke

    Measures cognition

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2018
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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