Status:
COMPLETED
BCI-assisted MI Intervention in Subacute Stroke
Lead Sponsor:
I.R.C.C.S. Fondazione Santa Lucia
Collaborating Sponsors:
University of Roma La Sapienza
Istituto Superiore di Sanità
Conditions:
Stroke
Motor Disorders
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Stroke is a leading cause of long-term disability. Cost-effective post-stroke rehabilitation programs are critically needed. Brain-Computer Interface (BCI) systems which enable the modulation of EEG s...
Detailed Description
Stroke is a major public health and social care concern worldwide, being the leading cause of long-term disability in adults. The upper limb motor impairment commonly persists after stroke affecting p...
Eligibility Criteria
Inclusion
- first ever unilateral stroke - confirmed by MRI;
- hemiplegia/hemiparesis from 1 to 6 months since stroke;
- age between 18 and 80 years;
Exclusion
- severe neglect and aphasia;
- dementia;
- severe spasticity - Modified Ashworth Scale \>4 at shoulder/elbow/wrist;
- Upper Extremity Fugl-Meyer Assessment (UE-FMA) \>47/60 score (60 is without considering 6 score point for tendon reflexes);
- Token test \>29 score;
- concomitant neurological disorders
Key Trial Info
Start Date :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04353297
Start Date
January 28 2021
End Date
December 1 2023
Last Update
February 28 2024
Active Locations (1)
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1
Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS
Rome, Italy, 00179