Back to resultstaVNS for Upper Limb Rehabilitation
Primary Purpose
Stroke
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Vagus Nerve Stimulation, Brain Stimulation, Occupational Therapy
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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
"paired" taVNS + Task Specific Training
"unpaired" taVNS + Task Specific Training
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04129242
First Posted
September 23, 2019
Last Updated
May 18, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT04129242
Brief Title
taVNS for Upper Limb Rehabilitation
Official Title
Optimization of Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) as a Neurorehabilitation Tool
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Vagus Nerve Stimulation, Brain Stimulation, Occupational Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"paired" taVNS + Task Specific Training
Arm Type
Active Comparator
Arm Title
"unpaired" taVNS + Task Specific Training
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training
Intervention Description
A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment of the Upper Extremity
Description
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.
Time Frame
Participants will be assessed weekly for the duration of the 4-week intervention, followed by 2 and 8 weeks post intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
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taVNS for Upper Limb Rehabilitation
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