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Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients

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ClinicalTrials.gov Identifier: NCT02878720
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University
Physical and Rehabilitation Medicine, Campus Bio-Medico University
Information provided by (Responsible Party):
Di Lazzaro Vincenzo, Campus Bio-Medico University

Brief Summary:
Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present study is to explore whether the combination of these two approaches might enhance their positive effects on motor recovery. Safety and efficacy of this combination will be assessed within a proof-of-principle, double-blinded, randomized, sham-controlled trial. Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to improve the response to the following robot-assisted therapy. Patients with both ischemic and hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as primary outcome, while changes in several quantitative indicators of motor performance extracted by the robot as secondary outcomes.

Condition or disease Intervention/treatment Phase
Stroke Device: Transcutaneous vagal nerve stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
Study Start Date : January 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Robotic therapy and real tVNS
This group receives REAL vagus nerve stimulation during robotic rehabilitation.
Device: Transcutaneous vagal nerve stimulation

The stimulation of the auricular branch of the vagus nerve will be performed through an electric stimulator and two Ag-AgCl electrodes placed in the left external acoustic meatus at the inner side of the tragus. For sham stimulation, electrodes will be attached to the left ear lobe. tVNS will be delivered as trains lasting 30 s and composed by 600 pulses (intra-train pulse frequency = 20 Hz; pulse duration = 0.3 ms) repeated every 5 min for 60 min. The intensity of stimulation will individually adjusted to a level ranging above the detection threshold and below the pain threshold. In this range, when possible, the investigators will chose an intensity of 8 mA.

Each day, for 10 consecutive working days, each patient will receive a session of robotic therapy during the real or sham tVNS stimulation


Active Comparator: Robotic therapy and sham tVNS
This group receives SHAM VNS during robotic rehabilitation. Sham VNS is not effective. Both groups receive the same amount of robotic rehabilitation.
Device: Transcutaneous vagal nerve stimulation

The stimulation of the auricular branch of the vagus nerve will be performed through an electric stimulator and two Ag-AgCl electrodes placed in the left external acoustic meatus at the inner side of the tragus. For sham stimulation, electrodes will be attached to the left ear lobe. tVNS will be delivered as trains lasting 30 s and composed by 600 pulses (intra-train pulse frequency = 20 Hz; pulse duration = 0.3 ms) repeated every 5 min for 60 min. The intensity of stimulation will individually adjusted to a level ranging above the detection threshold and below the pain threshold. In this range, when possible, the investigators will chose an intensity of 8 mA.

Each day, for 10 consecutive working days, each patient will receive a session of robotic therapy during the real or sham tVNS stimulation





Primary Outcome Measures :
  1. Change in Fugl-Meyer Score [ Time Frame: immediately, one months and three months after the intervention ]

Secondary Outcome Measures :
  1. Change in kinematic data (Motion Accuracy) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  2. Change in kinematic data (Motion Direction) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  3. Change in kinematic data (Smoothness) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  4. Change in kinematic data (Speed) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  5. Change in kinematic data (Movement Duration) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  6. Change in kinematic data (Efficiency) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  7. Incidence of adverse events that are related to treatment [ Time Frame: intervention period of 10 consecutive working days ]


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

Inclusion Criteria:

  • first-ever ischemic or hemorrhagic stroke at least 1 year earlier
  • hand function impairment
  • ability to give informed consent and comprehend instructions

Exclusion Criteria:

  • previous surgical intervention on vagus nerve
  • low hearth rate (< 60 bpm)
  • cognitive impairment or any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
  • apraxia
  • excessive pain in any joint of the paretic extremity
  • advanced liver, kidney, cardiac or pulmonary disease
  • history of significant alcohol or drug abuse
  • depression or use of neuropsychotropic drugs such as antidepressants or benzodiazepines
  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878720


Locations
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Italy
Institute of Neurology, Campus Biomedico University Recruiting
Rome, Italy, 00128
Contact: Vincenzo Di Lazzaro, MD    +39 06 22541 1320    v.dilazzaro@unicampus.it   
Principal Investigator: Fioravante Capone, MD         
Sponsors and Collaborators
Campus Bio-Medico University
Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University
Physical and Rehabilitation Medicine, Campus Bio-Medico University
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Responsible Party: Di Lazzaro Vincenzo, Full Professor of Neurology, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT02878720    
Other Study ID Numbers: VagusStroke
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Di Lazzaro Vincenzo, Campus Bio-Medico University:
ischemic stroke
hemorrhagic chronic
non-invasive vagus nerve stimulation
robot-assisted rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases