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RECRUITINGINTERVENTIONAL

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

Cortico-cortical Stimulation and Robot-assisted Therapy a New Approach of Upper Limb Functional Recovery After Stroke

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to tested the effect of combination of a paired associative stimulation of two functional interconnected areas of the cerebral cortex (posterior-parietal cortex and primary motor cortex) with robot-assisted therapy in the recovery of upper limb after stroke.

Who May Be Eligible (Plain English)

Who May Qualify: 1. first ever chronic ischemic stroke; 2. hemiparesis due to left or right subcortical or cortical lesion in the territory of the middle cerebral artery; 3. severe or moderate residual upper limb impairment (FMA \< 52 in the motor domain A/D) Who Should NOT Join This Trial: 1. history of seizures; 2. severe general impairment or concomitant diseases; 3. treatment with benzodiazepines, baclofen, and antidepressants; 4. Intracranial metal implants; 5. cardiac pacemaker; 6. pregnancy status; 7. orthopedic contraindications for upper limb; 8. upper limb pain; 9. cognitive impairment (MMSE \< 23); 10. presence of unilateral spatial neglect Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. first ever chronic ischemic stroke; 2. hemiparesis due to left or right subcortical or cortical lesion in the territory of the middle cerebral artery; 3. severe or moderate residual upper limb impairment (FMA \< 52 in the motor domain A/D) Exclusion Criteria: 1. history of seizures; 2. severe general impairment or concomitant diseases; 3. treatment with benzodiazepines, baclofen, and antidepressants; 4. Intracranial metal implants; 5. cardiac pacemaker; 6. pregnancy status; 7. orthopedic contraindications for upper limb; 8. upper limb pain; 9. cognitive impairment (MMSE \< 23); 10. presence of unilateral spatial neglect

Treatments Being Tested

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.

Locations (1)

Santa Lucia Foundation
Rome, Italy