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Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke (VaNSaRTS)

Primary Purpose

Stroke, Hemiparesis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

In Motion Rehabilitation Robot

About this trial

This is an interventional treatment trial for Stroke focused on measuring taVNS, Trans Auricular Vagus Nerve Stimulation, Robotic Training, Upper Limb Motor Recovery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

In receipt of full vaccination status and no recent upper respiratory symptoms and no loss of taste or olfaction.
Individuals between 18 and 85 years of age
First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).

Exclusion Criteria:

Recent fever or upper respiratory symptoms.
Botox treatment within 3 months of enrollment
Fixed contraction deformity in the affected limb
Complete and total flaccid paralysis of all shoulder and elbow motor performance
Prior injury to the vagus nerve
Severe dysphagia
Introduction of any new rehabilitation interventions during study
Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device
Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination
Pregnant or plan on becoming pregnant or breastfeeding during the study period
Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review)
Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination

Sites / Locations

Feinstein Institutes at Northwell HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

No Intervention

Arm Label

Affected Limb

Unaffected limb

Arm Description

Patients will wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement. Within subject. Sham controlled. Double blind, the patient will not know whether they are receiving taVNS, all patients feel a ramp up current but only the active group will receive timed stimulation bursts during the robotic protocol that engages the affected limb. '

Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure.

Outcomes

Primary Outcome Measures

Fugl-Meyer Motor Scale for the upper extremity

A standard well characterized measure of the movement ability of the subjects arm- shoulder, elbow, wrist, hand and fingers.

Secondary Outcome Measures

Action Research Arm Test (ARAT)

A standard evaluation of 19 different real world actions of the arm, including movements around the shoulder, elbow, wrist, hand and fingers.

Full Information

NCT ID

NCT05339893

First Posted

March 29, 2022

Last Updated

April 19, 2023

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT05339893

Brief Title

Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke

Acronym

VaNSaRTS

Official Title

Evaluating the Use of Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training to Improve Upper Limb Motor Recovery After Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 23, 2022 (Actual)

Primary Completion Date

April 18, 2024 (Anticipated)

Study Completion Date

April 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To determine whether treatment with transauricular vagus nerve stimulation (taVNS) during the training of an affected upper limb of a patient with chronic stroke on a robotic motor task alters the motor impairment.

Detailed Description

The investigators will evaluate whether transauricular vagus nerve stimulation (taVNS) delivered during extensor movements executed on a robotic device will alter the clinical measurement of upper limb motor performance in 45 patients with chronic stroke. Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure. Patients will then wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Hemiparesis

Keywords

taVNS, Trans Auricular Vagus Nerve Stimulation, Robotic Training, Upper Limb Motor Recovery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

To determine whether treatment with taVNS during the robotic training of a patient with stroke and a paralyzed arm will alter the motor impairment.

Masking

ParticipantInvestigator

Masking Description

The patient will not know whether they are receiving taVNS, all patients will feel a tingling in the ear as the current is ramped up and then down to determine a stimulation threshold, but only the active group will receive timed stimulation bursts during the robotic protocol that engages the affected limb. The measuring clinician will not know a patient's group assignment.

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Affected Limb

Arm Type

Sham Comparator

Arm Description

Arm Title

Unaffected limb

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

In Motion Rehabilitation Robot

Intervention Description

Primary Outcome Measure Information:

Title

Fugl-Meyer Motor Scale for the upper extremity

Description

A standard well characterized measure of the movement ability of the subjects arm- shoulder, elbow, wrist, hand and fingers.

Time Frame

30-45minutes

Secondary Outcome Measure Information:

Title

Action Research Arm Test (ARAT)

Description

A standard evaluation of 19 different real world actions of the arm, including movements around the shoulder, elbow, wrist, hand and fingers.

Time Frame

30-45minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: In receipt of full vaccination status and no recent upper respiratory symptoms and no loss of taste or olfaction. Individuals between 18 and 85 years of age First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI) Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist). Exclusion Criteria: Recent fever or upper respiratory symptoms. Botox treatment within 3 months of enrollment Fixed contraction deformity in the affected limb Complete and total flaccid paralysis of all shoulder and elbow motor performance Prior injury to the vagus nerve Severe dysphagia Introduction of any new rehabilitation interventions during study Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination Pregnant or plan on becoming pregnant or breastfeeding during the study period Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review) Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Celina B Fernandez, MS

Phone

516 562 3646

cfernandez14@northwell.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Bruce T Volpe, MD

Phone

5165623384

bvolpe1@northwell.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce T Volpe, MD

Organizational Affiliation

Feinstein Center for Molecular Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Timir Datta Chaudhuri, PhD

Organizational Affiliation

Feinstein Center for Bioelectronic Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Feinstein Institutes at Northwell Health

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruce T Volpe, MD

Phone

516-562-3384

bvolpe1@northwell.edu

First Name & Middle Initial & Last Name & Degree

Celina Fernandez, MS

Phone

(516)562-3646

cfernandez14@northwell.edu

12. IPD Sharing Statement

Learn more about this trial

Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke

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