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Hemiparetic Arm Robotic Mobilization With Non Invasive Electrical Stimulation

NCT03026712 · I.R.C.C.S. Fondazione Santa Lucia · Updated 8 July 2022

What is being tested
Real dual tDCS + Robotic Arm Therapy; SHAM tDCS + Robotic Arm Therapy
For
Stroke; Paresis; Upper Extremity Paralysis
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 80 people. The full rules are on the registry page.
Where
Italy (2 sites)
When
Starts or started Feb 2016, ends 1 Dec 2021. Registered 20 Jan 2017.
Results
None posted yet.

In the researchers' words

The two cerebral hemispheres find themselves in a state of balanced mutual inhibition. A stroke with involvement of motor function leads to a reduced excitability in affected hemisphere M1 and to an increased excitability of contralateral M1. Stroke therefore might impair interhemispheric balance, leading to a decreased inhibition of contralesional hemisphere by ipsilesional hemisphere and, in turn, to an increased inhibition of ipsilesional hemisphere by contralesional hemisphere. Permanence of healthy hemisphere hyperactivation in chronic phase after stroke is usually index of little functional recovery and is correlated with a greater ipsilateral structural damage. Robot-mediated physical therapy is an innovative rehabilitation technique that is effective in stroke patients. In this study, the investigators will add a non-invasive brain stimulation protocol with Transcranial stimulation with direct current (tDCS) to the robotic treatment in chronic stroke patients. tDCS is a non-invasive brain stimulation technique that is able to modulate cortical excitability. The hypothesis is that dual t-DCS (ipsilesional excitation and concomitant contralesional inhibition) could restore interhemispheric balance improving the benefits of robotic therapy with Armeo Power®.
ClinicalTrials.gov, NCT03026712

Sites

  • I.R.C.C.S. Fondazione Santa LuciaRome, Italy
  • Policlinico Universitario Campus Bio-MedicoRome, Italy