Hemiparetic Arm Robotic Mobilization With Non Invasive Electrical Stimulation

NCT03026712 | Completed DMC

• 1 other identifier: FSLCBM01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Robotic therapy; tDCS; non invasive electrical stimulation; ArmeoPower; interhemispheric balance

Outcome Measures

Primary Outcomes (1)

• Significant Fugl-Meyer Assessment Upper Extremity (FMA-UE) improvement in real dual tDCS group vs sham tDCS group

  first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training and at 1 and 3 months follow-up

Secondary Outcomes (5)

• Significant Modified Ashworth scale improvement in real dual tDCS group vs sham tDCS group

  first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training and at 1 and 3 months follow-up

• Significant Action Research Arm Test (ARAT) improvement in real dual tDCS group vs sham tDCS group

  first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training and at 1 and 3 months follow-up

• Significant Barthel index improvement in real dual tDCS group vs sham tDCS group

  first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training and at 1 and 3 months follow-up

• Significant kinematic performance improvement, measured by ArmeoPower®, in real dual tDCS group vs sham tDCS group

  first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training

• Significant rebalancing of motor evoked potential (MEP) laterality index in real dual tDCS group vs sham tDCS group

  first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training

Study Arms (2)

Real tDCS

EXPERIMENTAL

Device: Real dual tDCS + Robotic Arm Therapy

Sham tDCS

SHAM COMPARATOR

Device: SHAM tDCS + Robotic Arm Therapy

Interventions

Real dual tDCS + Robotic Arm Therapy DEVICE

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.

Real tDCS

SHAM tDCS + Robotic Arm Therapy DEVICE

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.

Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with isolated ischemic stroke, confirmed by brain imaging (MRI, CT)
• subjects who retain sufficient cognitive functions and language to follow the instructions given by doctors and therapists
• subjects with basal Modified Ashworth Scale score under 3
• subjects with basal Fugl-Meyer score ≥ 3 so that they are not completely paralyzed
• subjects who have signed informed consent to participate in this study
• subjects that show stable conditions in the two pre-treatment evaluations, in order to avoid "Hawthorne effect"

You may not qualify if:

• subjects with chronic paretic limb deformities
• subjects with complete and flaccid paralysis of all motor performances of shoulder and elbow;
• subjects with severe hemineglect (Pizzamiglio battery for unilateral spatial neglect including letter cancellation test, barrage tests, reading and Wundt-Jastro area illusion test; patients diagnosed with neglect if 3 of 4 items of this battery are present)
• subjects showing an increase in the Fugl-Meyer more than 2.1 points in the second pre-treatment clinical evaluation, compared to the score of the first evaluation
• subjects with contraindications to the execution of transcranial magnetic stimulation - TMS - (pacemakers, metal implants)
• subjects with epilepsy
• Previous neurosurgical interventions
• Severe upper limb osteoporosis
• Upper limb strength or joint movement limitation due to previous fractures
• Upper limb strength or joint movement limitation due to previous surgical interventions
• Mini Mental State Evaluation (MMSE) \<24

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• Campus Bio-Medico University: collaborator

Study Sites (2)

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

Rome, Italy

Location

Policlinico Universitario Campus Bio-Medico

Rome, Italy

Location

Related Publications (37)

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MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Paolucci

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

  STUDY DIRECTOR

• Vincenzo Di Lazzaro

  Policlinico Universitario Campus Bio-Medico, Roma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 20, 2017
• Study Start: February 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)