taVNS for Upper Limb Rehabilitation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129242
• Other study ID #: 00086291
• Secondary ID: 5P20GM109040
• Status: Completed
• Phase: Early Phase 1
• Start date: February 19, 2020
• Est. completion date: October 5, 2022

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fugl-Meyer Assessment of the Upper Extremity	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.	Mean change in FMA-UE score after 4 weeks of rehab, compared to baseline