RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-23

Study Completion:2025-04-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05339893

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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

Inclusion Criteria

Exclusion 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).

* 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

Contacts and Locations

Study Contact

Celina B Fernandez, MS

CONTACT

516 562 3646

cfernandez14@northwell.edu

Bruce T Volpe, MD

CONTACT

5165623384

bvolpe1@northwell.edu

Principal Investigator

Bruce T Volpe, MD

PRINCIPAL_INVESTIGATOR

Feinstein Center for Molecular Medicine

Timir Datta Chaudhuri, PhD

STUDY_DIRECTOR

Feinstein Center for Bioelectronic Medicine

Study Locations (Sites)

Feinstein Institutes at Northwell Health

Manhasset, New York, 11030

United States

Collaborators and Investigators

Sponsor: Northwell Health

Bruce T Volpe, MD, PRINCIPAL_INVESTIGATOR, Feinstein Center for Molecular Medicine
Timir Datta Chaudhuri, PhD, STUDY_DIRECTOR, Feinstein Center for Bioelectronic Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-23

Study Completion Date2025-04-18

Study Record Updates

Study Start Date2022-03-23

Study Completion Date2025-04-18

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Stroke
Hemiparesis