NCT04448483

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wyss Center for Bio and Neuroengineering · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 system is used alone or coupled with brain stimulation provided by transcranic direct current stimulation.

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 using electroencephalography (BrainVision, V-amp) activates a robotic glove (Gloreha Sinfonia, Idrogenet Srl) that will assist-as-needed hand movements and paretic upper limb functional electric stimulation (RehaStim, Hasomed). The latter will activate upper limb muscles to perform motor rehabilitation exercises for the upper limb. The motor rehabilitation exercises include upper limb and hand mobilization and functional tasks, such as hand open/closing, wrist flexion/extension, and reach and grasp a cup, keep and release. In the second intervention, non-invasive brain stimulation (DC-Stimulator, NeuroConn) in the form of transcranial direct current stimulation will be provided in addition to the previous intervention. Each participant will perform a minimum of 11 rehabilitative sessions for the first intervention and a minimum of 11 rehabilitative sessions for the second intervention, for a total minimum of 22 rehabilitative sessions. If the participant recovers with the intervention, the relative rehabilitative session continues to be proposed until patients will reaches a "plateau". The intervention will switch from 1 to 2 if the participant does not improve anymore with the 1st intervention. If the patient does not improve anymore with the 2nd intervention the interventional part of the trial will be finished. The intervention(s) will terminate also if the participant continues to progress after 6 months of inclusion. As the study is especially designed for personalization of intervention for every patient, it is not possible to determine a priori the number of sessions for each participant, because they depend on the response of each participant to the intervention. The duration of each rehabilitative visit is about two and half hours.

Conditions

• Stroke, Cerebral

Interventions

Type	Name	Description
DEVICE	Paretic upper limb functional electric stimulation through RehaStim	The stimulation will activate upper limb muscles to perform motor rehabilitation exercises for the upper limb with the help of the Gloreha Sinfonia robotic glove that will assist-as-needed hands movements. Motor intention will be detected by a BCI (Brain Computer Interface) from the non-invasive measure of brain activity by using electroencephalography. The motor rehabilitation exercises include upper limb and hand mobilization and functional tasks, such as hand open/closing, wrist flexion/extension, and reach and grasp a cup, keep and release.
DEVICE	Non-invasive transcranial current stimulation through DC-Stimulator	Non-invasive brain stimulation in the form of transcranial direct current stimulation will be provided in addition to the previous intervention.

Timeline

• Start date: 2020-10-06
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2020-06-26
• Last updated: 2023-12-05

Locations

1 site across 1 country: Switzerland