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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02878720
• Other study ID #: VagusStroke
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2022

Study information

• Verified date: January 2020
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Italy	Institute of Neurology, Campus Biomedico University	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Campus Bio-Medico University	Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University, Physical and Rehabilitation Medicine, Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fugl-Meyer Score		immediately, one months and three months after the intervention
Secondary	Change in kinematic data (Motion Accuracy) measured by the robot		immediately, one months and three months after the intervention
Secondary	Change in kinematic data (Motion Direction) measured by the robot		immediately, one months and three months after the intervention
Secondary	Change in kinematic data (Smoothness) measured by the robot		immediately, one months and three months after the intervention
Secondary	Change in kinematic data (Speed) measured by the robot		immediately, one months and three months after the intervention
Secondary	Change in kinematic data (Movement Duration) measured by the robot		immediately, one months and three months after the intervention
Secondary	Change in kinematic data (Efficiency) measured by the robot		immediately, one months and three months after the intervention
Secondary	Incidence of adverse events that are related to treatment		intervention period of 10 consecutive working days