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

NCT02878720 | Unknown

• 1 other identifier: VagusStroke
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

ischemic stroke; hemorrhagic chronic; non-invasive vagus nerve stimulation; robot-assisted rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Score

  immediately, one months and three months after the intervention

Secondary Outcomes (7)

• Change in kinematic data (Motion Accuracy) measured by the robot

  immediately, one months and three months after the intervention

• Change in kinematic data (Motion Direction) measured by the robot

  immediately, one months and three months after the intervention

• Change in kinematic data (Smoothness) measured by the robot

  immediately, one months and three months after the intervention

• Change in kinematic data (Speed) measured by the robot

  immediately, one months and three months after the intervention

• Change in kinematic data (Movement Duration) measured by the robot

  immediately, one months and three months after the intervention

Study Arms (2)

Robotic therapy and real tVNS

EXPERIMENTAL

This group receives REAL vagus nerve stimulation during robotic rehabilitation.

Device: Transcutaneous vagal nerve stimulation

Robotic therapy and sham tVNS

ACTIVE COMPARATOR

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

Interventions

Transcutaneous vagal nerve stimulation DEVICE

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

Robotic therapy and real tVNS; Robotic therapy and sham tVNS

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead
• Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University: collaborator
• Physical and Rehabilitation Medicine, Campus Bio-Medico University: collaborator

Study Sites (1)

Institute of Neurology, Campus Biomedico University

Rome, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Neurology

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 25, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)