taVNS for Upper Limb Rehabilitation

NCT ID: NCT04129242

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-19
• Study Completion Date: 2022-10-05

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)

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"paired" taVNS + Task Specific Training

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

"unpaired" taVNS + Task Specific Training

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Bashar Badran

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P20GM109040

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00086291

Identifier Type: -

Identifier Source: org_study_id