Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 14 of 109 for:    harmony

Hemiparetic Arm Robotic Mobilization With Non Invasive Electrical Stimulation (hARMonies)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Campus Bio-Medico University
Information provided by (Responsible Party):
Giovanni Morone, I.R.C.C.S. Fondazione Santa Lucia
ClinicalTrials.gov Identifier:
NCT03026712
First received: January 12, 2017
Last updated: January 17, 2017
Last verified: January 2017
  Purpose

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®.


Condition Intervention
Stroke
Paresis
Upper Extremity Paralysis
Device: Real dual tDCS + Robotic Arm Therapy
Device: SHAM tDCS + Robotic Arm Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Association of Dual Transcranial Electrical Stimulation (tDCS) to Upper Limb Robotic Therapy in Individuals With Chronic Stroke

Resource links provided by NLM:


Further study details as provided by Giovanni Morone, I.R.C.C.S. Fondazione Santa Lucia:

Primary Outcome Measures:
  • Significant Fugl-Meyer Assessment Upper Extremity (FMA-UE) improvement in real dual tDCS group vs sham tDCS group [ Time Frame: 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 Outcome Measures:
  • Significant Modified Ashworth scale improvement in real dual tDCS group vs sham tDCS group [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: first assessment will occur within 2 days from enrollment, and will be repeated within 2 days from the end of 2 week-training ]

Estimated Enrollment: 80
Study Start Date: February 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Real tDCS 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.

Sham Comparator: Sham tDCS 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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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"

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03026712

Locations
Italy
I.R.C.C.S. Fondazione Santa Lucia
Rome, Italy
Policlinico Universitario Campus Bio-Medico
Rome, Italy
Sponsors and Collaborators
I.R.C.C.S. Fondazione Santa Lucia
Campus Bio-Medico University
Investigators
Study Director: Stefano Paolucci I.R.C.C.S. Fondazione Santa Lucia, Roma
Study Director: Vincenzo Di Lazzaro Policlinico Universitario Campus Bio-Medico, Roma
  More Information

Publications:
Kinsbourne, M. (1974). Mechanisms of hemispheric interaction in man. In Hemispheric Disconnection and Cerebral Function, M. Kinsbourne, and W. Smith, eds. (Springfield: Charles C Thomas).

Responsible Party: Giovanni Morone, MD, PhD, I.R.C.C.S. Fondazione Santa Lucia
ClinicalTrials.gov Identifier: NCT03026712     History of Changes
Other Study ID Numbers: FSLCBM01
Study First Received: January 12, 2017
Last Updated: January 17, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Giovanni Morone, I.R.C.C.S. Fondazione Santa Lucia:
Robotic therapy
tDCS
non invasive electrical stimulation
ArmeoPower
interhemispheric balance

Additional relevant MeSH terms:
Stroke
Paralysis
Paresis
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 25, 2017