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Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients

NCT02878720 · Campus Bio-Medico University · Updated 27 Jan 2020

What is being tested
Transcutaneous vagal nerve stimulation
For
Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 30 people. The full rules are on the registry page.
Where
Italy
When
Starts or started Jan 2016, ends Dec 2022. Registered 25 Aug 2016.
Results
None posted yet.

In the researchers' words

Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present study is to explore whether the combination of these two approaches might enhance their positive effects on motor recovery. Safety and efficacy of this combination will be assessed within a proof-of-principle, double-blinded, randomized, sham-controlled trial. Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to improve the response to the following robot-assisted therapy. Patients with both ischemic and hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as primary outcome, while changes in several quantitative indicators of motor performance extracted by the robot as secondary outcomes.
ClinicalTrials.gov, NCT02878720

Sites

  • Institute of Neurology, Campus Biomedico UniversityRome, Italy