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

Campus Bio-Medico University of Rome

Status: Unknown

Conditions: Stroke

Treatments: Device: Transcutaneous vagal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02878720

VagusStroke

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Robotic therapy and real tVNS

Experimental group

Description:

This group receives REAL vagus nerve stimulation during robotic rehabilitation.

Treatment:

Device: Transcutaneous vagal nerve stimulation

Robotic therapy and sham tVNS

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous vagal nerve stimulation