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

NCT ID: NCT02878720

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robotic therapy and real tVNS

This group receives REAL vagus nerve stimulation during robotic rehabilitation.

Group Type: EXPERIMENTAL

Transcutaneous vagal nerve stimulation

Intervention Type: 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 sham tVNS

This group receives SHAM VNS during robotic rehabilitation. Sham VNS is not effective. Both groups receive the same amount of robotic rehabilitation.

Group Type: ACTIVE_COMPARATOR

Transcutaneous vagal nerve stimulation

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University

UNKNOWN

Sponsor Role: collaborator

Physical and Rehabilitation Medicine, Campus Bio-Medico University

UNKNOWN

Sponsor Role: collaborator

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Di Lazzaro Vincenzo

Full Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Neurology, Campus Biomedico University

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Vincenzo Di Lazzaro, MD

Role: primary

v.dilazzaro@unicampus.it

+39 06 22541 1320

Other Identifiers

VagusStroke

Identifier Type: -

Identifier Source: org_study_id