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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Affected Limb | Sham Comparator | 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. ' |
|
| Unaffected limb | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In Motion Rehabilitation Robot | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30-45minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30-45minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celina B Fernandez, MS | Contact | 516 562 3646 | cfernandez14@northwell.edu | |
| Bruce T Volpe, MD | Contact | 5165623384 | bvolpe1@northwell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bruce T Volpe, MD | Feinstein Center for Molecular Medicine | Principal Investigator |
| Timir Datta Chaudhuri, PhD | Feinstein Center for Bioelectronic Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institutes at Northwell Health | Recruiting | Manhasset | New York | 11030 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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To determine whether treatment with taVNS during the robotic training of a patient with stroke and a paralyzed arm will alter the motor impairment.
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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.
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |