Status:
COMPLETED
Clinical Study for Upper Limb Motor Restoration in Chronic Stroke Patients Using Personalized Neuro-technologies
Lead Sponsor:
Wyss Center for Bio and Neuroengineering
Collaborating Sponsors:
Ecole Polytechnique Fédérale de Lausanne
Conditions:
Stroke, Cerebral
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to evaluate safety, tolerability and efficacy of a new treatment for upper limb motor rehabilitation after severe stroke using non-invasive neurotechnologies. The investigational syste...
Detailed Description
This study aims at providing two interventions: In the first intervention, a brain computer interface able to non-invasively detect motor intention from the non-invasive measure of brain activity by ...
Eligibility Criteria
Inclusion
- Chronic cerebral stroke patients (at least 6 months after the event).
- First ever clinical manifest stroke.
- No or minimal residual voluntary finger extension.
- Upper limb FM score \< 20.
- Age \> 18 years.
- Right or left severe hemiparesis.
- Ischemic or hemorrhagic stroke with intact hand knob area.
Exclusion
- Patient with an active implantable device or wearing an active device.
- Occurrence of new clinically manifest stroke.
- Cerebellar stroke.
- Drug or alcohol dependency.
- Pregnancy.
- Refusal to perform any proposed pregnancy test for women in childbearing age (18 to menopausal age).
- Psychotic symptoms and significant psychopharmacologic treatments with neuroleptics and/or Lithium and antiepileptics
- Use of medication that significantly interacts with non-invasive brain stimulation being benzodiazepines, tricyclic antidepressant and antipsychotics.
- Severe spasticity that prevent the patient to use the robotic orthosis (indicative Modified Ashworth Scale \> 3).
- Severe cognitive problems and severe neglect.
- Physical features impeding the recording of brain signals or the muscular signals stimulation (voluminous hair and large amount of subcutaneous fat in the arms).
- Severe heart disease.
- Allergy to latex and dermatitis.
- Epileptic seizures or using medications that reduce the threshold for epileptic seizures.
- Travel distance to the study site more than 70 Km.
- Involvement in other clinical treatment trials related to stroke.
- Participant does not want to be informed about the potential fortuitous discoveries that may contribute to the prevention, diagnosis and treatment of existing or probable diseases in the future.
Key Trial Info
Start Date :
October 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04448483
Start Date
October 6 2020
End Date
November 17 2023
Last Update
December 5 2023
Active Locations (1)
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1
Clinique Romande de Readaptation (CRR)
Sion, Switzerland