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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

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 25, 2016
Last Update Posted Date January 27, 2020
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2016)
Change in Fugl-Meyer Score [ Time Frame: immediately, one months and three months after the intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2016)
  • Change in kinematic data (Motion Accuracy) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  • Change in kinematic data (Motion Direction) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  • Change in kinematic data (Smoothness) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  • Change in kinematic data (Speed) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  • Change in kinematic data (Movement Duration) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  • Change in kinematic data (Efficiency) measured by the robot [ Time Frame: immediately, one months and three months after the intervention ]
  • Incidence of adverse events that are related to treatment [ Time Frame: intervention period of 10 consecutive working days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
Official Title  ICMJE Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE 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

Study Arms  ICMJE
  • Experimental: Robotic therapy and real tVNS
    This group receives REAL vagus nerve stimulation during robotic rehabilitation.
    Intervention: Device: Transcutaneous vagal nerve 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.
    Intervention: Device: Transcutaneous vagal nerve stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2016)
50
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02878720
Other Study ID Numbers  ICMJE VagusStroke
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Di Lazzaro Vincenzo, Campus Bio-Medico University
Study Sponsor  ICMJE Campus Bio-Medico University
Collaborators  ICMJE
  • Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University
  • Physical and Rehabilitation Medicine, Campus Bio-Medico University
Investigators  ICMJE Not Provided
PRS Account Campus Bio-Medico University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP