StrokeNCT03407547
A Study Exploring Brain Activity in Relation to Sensory Arm Impairments in the Early Stages of Stroke
A study testing Electroencephalography in people with Stroke, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Electroencephalography
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2018to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Electroencephalography
- Keywords
- upper limb, recovery, somatosensory, impairment, electroencephalography, acute phase
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDiagnostic test
EEG is a device to measure brain activity via surface electrodes
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Evoked Potential Latency
EEG measurement
Measured: First 2 weeks post-stroke
Sensory Evoked Potential Amplitude
EEG measurement
Measured: First 2 weeks post-stroke
Secondary outcomes (6)
Fugl Meyer Assessment
Upper limb motor impairment measurement
Measured: First 2 weeks post-stroke
Wolf Motor Function Test
Upper limb activities measurement
Measured: First 2 weeks post-stroke
Perceptual Threshold of Touch
Light touch of the palmar surface of index finger
Measured: First 2 weeks post-stroke
Erasmus modified Nottingham Sensory Assessment
Measures somatosensation of the upper limb and hand
Measured: First 2 weeks post-stroke
Nottingham Sensory Assessment
Measures stereognosis
Measured: First 2 weeks post-stroke
Montreal Cognitive Assessment
Measures cognition
Measured: First 2 weeks post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Nov 2018
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407547
- Sponsor's protocol ID
- S61174
- Status last verified
- Jul 2024
- First submitted
- 8 Jan 2018
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Upper Limb Somatosensory Impairments and Recovery in the Acute Phase After Stroke: an EEG Investigation
- ClinicalTrials.gov ID
- NCT03407547
- Acronym / sponsor ID
- S61174
- Conditions
- Stroke
- Keywords
- upper limb, recovery, somatosensory, impairment, electroencephalography, acute phase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroencephalographyEEG is a device to measure brain activity via surface electrodes | Diagnostic test | – |
Primary outcome
Sensory Evoked Potential Latency
Time frame: First 2 weeks post-stroke
EEG measurement
Sensory Evoked Potential Amplitude
Time frame: First 2 weeks post-stroke
EEG measurement
6 secondary outcomes
Fugl Meyer Assessment
Time frame: First 2 weeks post-stroke
Wolf Motor Function Test
Time frame: First 2 weeks post-stroke
Perceptual Threshold of Touch
Time frame: First 2 weeks post-stroke
Erasmus modified Nottingham Sensory Assessment
Time frame: First 2 weeks post-stroke
Nottingham Sensory Assessment
Time frame: First 2 weeks post-stroke
Montreal Cognitive Assessment
Time frame: First 2 weeks post-stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography in people with Stroke, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Evoked Potential Latency (time frame: First 2 weeks post-stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.