Clinical trial NCT02878720: Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
Official title: Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: ischemic stroke
hemorrhagic chronic
non-invasive vagus nerve stimulation
robot-assisted rehabilitation
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
Collaborators: name: Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University
name: Physical and Rehabilitation Medicine, Campus Bio-Medico University
First posted: 2016-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Fugl-Meyer Score
timeFrame: immediately, one months and three months after the intervention
Secondary outcomes:
measure: Change in kinematic data (Motion Accuracy) measured by the robot
timeFrame: immediately, one months and three months after the intervention
measure: Change in kinematic data (Motion Direction) measured by the robot
timeFrame: immediately, one months and three months after the intervention
measure: Change in kinematic data (Smoothness) measured by the robot
timeFrame: immediately, one months and three months after the intervention
measure: Change in kinematic data (Speed) measured by the robot
timeFrame: immediately, one months and three months after the intervention
measure: Change in kinematic data (Movement Duration) measured by the robot
timeFrame: immediately, one months and three months after the intervention
measure: Change in kinematic data (Efficiency) measured by the robot
timeFrame: immediately, one months and three months after the intervention
measure: Incidence of adverse events that are related to treatment
timeFrame: intervention period of 10 consecutive working days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Institute of Neurology, Campus Biomedico University
Study officials:
References: