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

NCT03407547 | Active Not Recruiting

• 1 other identifier: S61174
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

upper limb; recovery; somatosensory; impairment; electroencephalography; acute phase

Outcome Measures

Primary Outcomes (2)

• Sensory Evoked Potential Latency

  EEG measurement

  First 2 weeks post-stroke

• Sensory Evoked Potential Amplitude

  EEG measurement

  First 2 weeks post-stroke

Secondary Outcomes (6)

• Fugl Meyer Assessment

  First 2 weeks post-stroke

• Wolf Motor Function Test

  First 2 weeks post-stroke

• Perceptual Threshold of Touch

  First 2 weeks post-stroke

• Erasmus modified Nottingham Sensory Assessment

  First 2 weeks post-stroke

• Nottingham Sensory Assessment

  First 2 weeks post-stroke

Interventions

Electroencephalography DIAGNOSTIC_TEST

EEG is a device to measure brain activity via surface electrodes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Saint Luc Hospital

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Stroke

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 23, 2018
• Study Start: November 1, 2018
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)