taVNS for Upper Limb Rehabilitation

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT04129242

Collaborator

National Institutes of Health (NIH) (NIH), National Institute of General Medical Sciences (NIGMS) (NIH)

Enrollment

Location

Arms

49.3

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients. Patients will undergo a series of baseline assessments (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments (including a second brain scan)

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training	Early Phase 1

Detailed Description

This study aims to refine and develop closed loop taVNS, establish activity with key biomarkers, and show initial feasibility in a small clinical trial. For paired taVNS to succeed as a clinical treatment, it is critical to develop and refine a closed-loop taVNS platform that delivers stimulation concurrently during specific movements of the motor rehabilitation training.

Aim 1 develops this novel motion-gated closed-loop system that delivers taVNS in synchrony with specific upper limb motor activation (n=5) Aim 2 will combine the development of the closed-loop system with the investigator's mechanistic understanding to explore an open-label pilot trial (n=20) using closed-loop taVNS paired with task-specific training to determine the feasibility, safety, and potential effect size of this novel combination therapy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Optimization of Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) as a Neurorehabilitation Tool

Actual Study Start Date :

Feb 19, 2020

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: "paired" taVNS + Task Specific Training	Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.
Active Comparator: "unpaired" taVNS + Task Specific Training	Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.

Arm

Intervention/Treatment

Active Comparator: "paired" taVNS + Task Specific Training

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training

A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.

Active Comparator: "unpaired" taVNS + Task Specific Training

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training

A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.

Outcome Measures

Primary Outcome Measures

Change in Fugl-Meyer Assessment of the Upper Extremity [Participants will be assessed weekly for the duration of the 4-week intervention, followed by 2 and 8 weeks post intervention.]
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Possible aggregate scores range from 0/66 to 66/66 points. Higher scores indicate greater levels of arm movement ability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-80 years old
Ischemic or hemorrhagic stroke that occurred at least 6 months prior
Completed conventional rehabilitation therapy at least one month prior
Unilateral limb weakness with Fugl Meyer-Upper Extremity Scale score less than or equal to 58 (out of 66)

Exclusion Criteria:

Primary intracerebral hematoma, or subarachnoid hemorrhage
Bilateral upper extremity weakness
Other concomitant neurological disorders affecting upper extremity motor function
Documented history of dementia before or after stroke
Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment
Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) >=180/100mmHg at baseline
Contraindicated for MRI scanning.