Cortico-cortical Stimulation and Robot-assisted Therapy for Upper Limb Recovery After Stroke (CCS&RAT)

NARecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

August 21, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

October 31, 2025

Conditions
StrokeStroke, Ischemic
Interventions
DEVICE

Cortico-cortical stimulation plus robot-assisted therapy

15 sessions of cortico-cortical stimulation between the PPC and the M1 of the lesioned hemisphere and robot-assisted therapy. Paired-pulse stimulation (PAS) technique, with 5ms inter-stimulus time between the two areas (PPC to M1), will be done through two high-power Magstim 200 machines (Magstim® Rapid²). To stimulate the M1 area, the coil will be placed tangentially to the scalp at a 45° angle to the midline, to stimulate the PPC area the center of the coil will be positioned over P4 (10-20 EEG system) tangentially to the skull with the handle pointing downward and slightly medial (10°). Robot-assisted therapy will be performed with an Armeo® Power II (Hocoma), an integrative system composed by a robotic exoskeleton device connected to a laptop for the audio-visual biofeedback for the upper limb therapy.

DEVICE

Sham cortico-cortical stimulation plus robot-assisted therapy

15 sessions of sham cortico-cortical stimulation between the PPC and the M1 of the lesioned hemisphere and robot-assisted therapy. Sham paired-pulse stimulation (PAS) will be done through two high-power Magstim 200 machines (Magstim® Rapid²). To simulate the real stimulation, the coils will placed in the same sites with different inclination respect to the scalp (90°). Robot-assisted therapy will be performed with an Armeo® Power II (Hocoma), an integrative system composed by a robotic exoskeleton device connected to a laptop for the audio-visual biofeedback for the upper limb therapy.

Trial Locations (1)

00179

RECRUITING

Santa Lucia Foundation, Rome

All Listed Sponsors
collaborator

Università degli studi di Roma Foro Italico

OTHER

lead

I.R.C.C.S. Fondazione Santa Lucia

OTHER