Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke
NCT05339893 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2023-04-21
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.
Conditions
- Stroke
- Hemiparesis
Interventions
- DEVICE
-
In Motion Rehabilitation Robot
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.
Sponsors & Collaborators
-
Northwell Health
lead OTHER
Principal Investigators
-
Bruce T Volpe, MD · Feinstein Center for Molecular Medicine
-
Timir Datta Chaudhuri, PhD · Feinstein Center for Bioelectronic Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-03-23
- Primary Completion
- 2024-04-18
- Completion
- 2025-04-18
- FDA Device
- Yes
Countries
- United States
Study Locations
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