Status:
UNKNOWN
BCI Driving FES and Hand Orthosis for Upper Limb Rehabilitation in Chronic Stroke
Lead Sponsor:
University of Essex
Collaborating Sponsors:
Azienda Sanitaria dell'Alto Adige
Landeskrankenhaus Hochzirl
Conditions:
Stroke, Cerebrovascular
Hemiplegia and Hemiparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multi-center, randomized, sham-controlled, double-blind, longitudinal, experimental clinical study to investigate functional recovery effects on the upper limb in chronic stroke patients and the accom...
Detailed Description
This study will investigate whether the combination of FES and an active orthosis assisting the execution of "reach-to-grasp and release" functional arm movements, triggered by a non-invasive, EEG-bas...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- More than 18 years of age
- Victim of ischemic or haemorrhagic cerebrovascular accident (CVA)
- At least 6 months since occurrence of CVA. No upper limit on time since stroke is imposed
- First CVA
- Severe central paresis or complete paralysis of the upper limb, as quantified by a Medical Research Council (MRC) scale score ≤2 evaluated at the wrist and finger extension and flexion, and forearm flexion and extension Other concomitant motor disabilities do not constitute exclusion criteria.
- Unilateral cortical lesions (left or right hemisphere), subcortical lesions or supra-pontic lesions of the corticospinal tract having caused paralysis of the upper limb as documented by radiologic evidence
- Adequate or corrected vision
- Exclusion criteria:
- Any reason obstructing EEG acquisition (scalp infections or wounds, dermatitis, etc)
- Severe concomitant diseases (fever, infections, cardiac conditions, etc)
- Heavy medication affecting the central nervous system (CNS, especially vigilance)
- CVA with multiple infarcts
- Second or later CVA
- Severe unilateral hemispatial neglect as assessed by the behavioural part of the Behavioural Inattention Test (BIT) and the Fluff Test for body neglect
- Severe cognitive disability affecting speech production, communication (e.g. aphasia), the ability to understand and give clear and free informed consent and to fully understand and comply with protocol instructions. A score of above 22/30 of the Montreal Cognitive Assessment (MoCA) scale is advised Inability to concentrate for 2 consecutive hours
- Concomitant neurological conditions (e.g. Parkinson's disease) Severe spasticity. The Modified Ashworth Scale (MAS) score at the elbow, wrist and fingers should be below or equal to 2.
- Severe dystonia, dyskinesia or pain
- Cardiac pacemaker, active implants and other contraindications for FES
- Metallic implants affecting EEG acquisition
- Patients for whom it is not possible to evoke a MEP greater than or equal to 0.2 mV amplitude at rest from the FDI and more proximal muscles (like ECR, FDS, etc) of the affected limb, or with contraindications for the TMS or Diffusion Tensor Imaging (DTI) protocols, will not undergo the respective procedures but will not be excluded from the trial.
Exclusion
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06179745
Start Date
March 14 2022
End Date
March 31 2025
Last Update
December 22 2023
Active Locations (1)
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1
Ospedale di Vipiteno | Azienda Sanitaria dell'Alto Adige
Sterzing, Trentino-Alto Adige, Italy, 39049