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Clinical Study for Upper Limb Motor Restoration in Chronic Stroke Patients Using Personalized Neuro-technologies

NCT04448483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-05

No results posted yet for this study

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.

Conditions

  • Stroke, Cerebral

Interventions

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.

Sponsors & Collaborators

  • Ecole Polytechnique Fédérale de Lausanne

    collaborator OTHER

  • Wyss Center for Bio and Neuroengineering

    lead OTHER

Principal Investigators

  • Friedhelm Hummel, MD · Ecole Politechnique Federale de Lausanne

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2023-11-17
Completion
2023-11-17

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04448483 on ClinicalTrials.gov