StrokeNCT02878720
Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
A study testing Transcutaneous vagal nerve stimulation in people with Stroke, run by Campus Bio-Medico University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Transcutaneous vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first-ever ischemic or hemorrhagic stroke at least 1 year earlier
- hand function impairment
- ability to give informed consent and comprehend instructions
Who cannot join
- 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
Show all 9Show fewer
- history of significant alcohol or drug abuse
- depression or use of neuropsychotropic drugs such as antidepressants or benzodiazepines
- pregnant women
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute of Neurology, Campus Biomedico University
Rome, 00128
Vincenzo Di Lazzaro, MD, +39 06 22541 1320, v.dilazzaro@unicampus.it
Fioravante Capone, MD
About this study
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
- Being tested
- Transcutaneous vagal nerve stimulation
- Keywords
- ischemic stroke, hemorrhagic chronic, non-invasive vagus nerve stimulation, robot-assisted rehabilitation
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagal nerve stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Robotic therapy and real tVNS | Experimental | This group receives REAL vagus nerve stimulation during robotic rehabilitation. Receives: 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. Receives: Device: Transcutaneous vagal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Score
Measured: immediately, one months and three months after the intervention
Secondary outcomes (7)
Change in kinematic data (Motion Accuracy) measured by the robot
Measured: immediately, one months and three months after the intervention
Change in kinematic data (Motion Direction) measured by the robot
Measured: immediately, one months and three months after the intervention
Change in kinematic data (Smoothness) measured by the robot
Measured: immediately, one months and three months after the intervention
Change in kinematic data (Speed) measured by the robot
Measured: immediately, one months and three months after the intervention
Change in kinematic data (Movement Duration) measured by the robot
Measured: immediately, one months and three months after the intervention
Change in kinematic data (Efficiency) measured by the robot
Measured: immediately, one months and three months after the intervention
Incidence of adverse events that are related to treatment
Measured: intervention period of 10 consecutive working days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University, Physical and Rehabilitation Medicine, Campus Bio-Medico University
- Responsible party
- Principal investigator, Di Lazzaro Vincenzo, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878720
- Sponsor's protocol ID
- VagusStroke
- Status last verified
- Jan 2020
- First submitted
- 16 Aug 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT02878720
- Acronym / sponsor ID
- VagusStroke
- Conditions
- Stroke
- Keywords
- ischemic stroke, hemorrhagic chronic, non-invasive vagus nerve stimulation, robot-assisted rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Collaborators
- Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University, Physical and Rehabilitation Medicine, Campus Bio-Medico University
- Study start
- Jan 2016
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic therapy and real tVNS | Experimental | Device: Transcutaneous vagal nerve stimulationThis group receives REAL vagus nerve stimulation during robotic rehabilitation. |
| Robotic therapy and sham tVNS | Active comparator | Device: Transcutaneous vagal nerve stimulationThis group receives SHAM VNS during robotic rehabilitation. Sham VNS is not effective. Both groups receive the same amount of robotic rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- first-ever ischemic or hemorrhagic stroke at least 1 year earlier
- hand function impairment
- ability to give informed consent and comprehend instructions
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagal nerve stimulationThe 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 | Device | Robotic therapy and real tVNS, Robotic therapy and sham tVNS |
Primary outcome
Change in Fugl-Meyer Score
Time frame: immediately, one months and three months after the intervention
7 secondary outcomes
Change in kinematic data (Motion Accuracy) measured by the robot
Time frame: immediately, one months and three months after the intervention
Change in kinematic data (Motion Direction) measured by the robot
Time frame: immediately, one months and three months after the intervention
Change in kinematic data (Smoothness) measured by the robot
Time frame: immediately, one months and three months after the intervention
Change in kinematic data (Speed) measured by the robot
Time frame: immediately, one months and three months after the intervention
Change in kinematic data (Movement Duration) measured by the robot
Time frame: immediately, one months and three months after the intervention
Change in kinematic data (Efficiency) measured by the robot
Time frame: immediately, one months and three months after the intervention
Incidence of adverse events that are related to treatment
Time frame: intervention period of 10 consecutive working days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Institute of Neurology, Campus Biomedico University
Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagal nerve stimulation in people with Stroke, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Score (time frame: immediately, one months and three months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.