NCT04448483Completed
Clinical Study for Upper Limb Motor Restoration in Chronic Stroke Patients Using Personalized Neuro-technologies
Accident Vasculaire cérébral et Apport Des Neurotechnologies individualisées Chez la Personne Avec Une hémiparésie Chronique : Une Etude Clinique Prospective Visant à Restaurer la mobilité du Membre supérieur
Source: ClinicalTrials.gov · Last updated 5 Dec 2023
Brief summary (registry, in English)
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 system is used alone or coupled with brain stimulation provided by transcranic direct current stimulation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 15 Jun 2020
- Start date
- 6 Oct 2020
- Primary completion date
- 17 Nov 2023
- Lead sponsor
- Wyss Center for Bio and Neuroengineering
- Diseases
- Stroke
- NCT number
- NCT04448483
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 6 Oct 2020 to the primary completion date, 17 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug or alcohol dependency.
- Use of medication that significantly interacts with non-invasive brain stimulation being benzodiazepines, tricyclic antidepressant and antipsychotics.
Other illness
- Occurrence of new clinically manifest stroke.
- Cerebellar stroke.
- Severe heart disease.
- Allergy to latex and dermatitis.
- Epileptic seizures or using medications that reduce the threshold for epileptic seizures.
- 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.
Age
- Refusal to perform any proposed pregnancy test for women in childbearing age (18 to menopausal age).
Other
- Patient with an active implantable device or wearing an active device.
- Pregnancy.
- Psychotic symptoms and significant psychopharmacologic treatments with neuroleptics and/or Lithium and antiepileptics
- 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).
- Travel distance to the study site more than 70 Km.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Romande de Readaptation (CRR) Coordinator of this site? Confirm its status | Sion | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.