ClinicalTrials.gg
Status unknownNCT03407547Updated Jul 3, 2024

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

An interventional study of Electroencephalography in Stroke, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

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Keywords

  • upper limb
  • recovery
  • somatosensory
  • impairment
  • electroencephalography
  • acute phase
03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Interventions

  • Diagnostic testElectroencephalography

    EEG is a device to measure brain activity via surface electrodes

06

What researchers measure

Primary outcomes

  1. Sensory Evoked Potential Latency

    EEG measurement

    Time frame: First 2 weeks post-stroke

  2. Sensory Evoked Potential Amplitude

    EEG measurement

    Time frame: First 2 weeks post-stroke

Secondary outcomes

  1. Fugl Meyer Assessment

    Upper limb motor impairment measurement

    Time frame: First 2 weeks post-stroke

  2. Wolf Motor Function Test

    Upper limb activities measurement

    Time frame: First 2 weeks post-stroke

  3. Perceptual Threshold of Touch

    Light touch of the palmar surface of index finger

    Time frame: First 2 weeks post-stroke

  4. Erasmus modified Nottingham Sensory Assessment

    Measures somatosensation of the upper limb and hand

    Time frame: First 2 weeks post-stroke

  5. Nottingham Sensory Assessment

    Measures stereognosis

    Time frame: First 2 weeks post-stroke

  6. Montreal Cognitive Assessment

    Measures cognition

    Time frame: First 2 weeks post-stroke

07

Study locations

1 site
  • Saint Luc Hospital
    Brussels, 1200, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2018 (actual). Primary completion is estimated for Sep 2025, 82 months after the start.

Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 82 months is above that.

Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2018
First posted
Jan 23, 2018
StartActual
Nov 1, 2018
Primary completionEst.
Sep 2025
CompletionEst.
Dec 2025
Last update
Jul 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03407547
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Nov 1, 2018
Primary completion
Sep 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jul 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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