Hemiparetic Arm Robotic Mobilization With Non Invasive Electrical Stimulation

Summary

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®.

Conditions

• Stroke
• Paresis
• Upper Extremity Paralysis

Interventions

DEVICE

Real dual tDCS + Robotic Arm Therapy

Dual tDCS (anodic on injured hemisphere, cathodic on healthy hemisphere). Motor cortex will be simultaneously stimulated at an intensity equal to 1-2 mA and for a maximum duration of 20 minutes just before 30 minutes of arm robotic task oriented treatment performed with an exoskeleton device (Armeo Power). The intervention will be performed 5 times per week for 2 consecutive weeks.

DEVICE

SHAM tDCS + Robotic Arm Therapy

SHAM bilateral tDCS for a maximum duration of 20 minutes just before 30 minutes of arm robotic task oriented treatment performed with an exoskeleton device (Armeo Power). The intervention will be performed 5 times per week for 2 consecutive weeks.

Sponsors & Collaborators

• Campus Bio-Medico University

  collaborator OTHER

• I.R.C.C.S. Fondazione Santa Lucia

  lead OTHER

Principal Investigators

• Stefano Paolucci · I.R.C.C.S. Fondazione Santa Lucia, Roma

• Vincenzo Di Lazzaro · Policlinico Universitario Campus Bio-Medico, Roma

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2021-12-01

Completion

2021-12-01

Countries

• Italy

Study Locations