Stroke, Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Brief summary
Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.
Detailed description
This study seeks to advance prior research conducted here at MUSC exploring the use of transcutaneous auricular vagus nerve stimulation (taVNS) paired with motor rehabilitation to improve motor function post-stroke. Early evidence from a recently completed NIH-funded, clinical trial suggests that our new approach of delivering electrical stimulation to the ear at the same time as motor rehabilitation double the clinical benefits of motor rehabilitation. These benefits are due in part to a facilitation of neuroplasticity caused by activating the auricular branch of the vagus nerve. This project takes this approach one step further, moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas. In order to accomplish this, investigators will a) conduct lab-based testing and validation of the stimulation triggering sensors for at-home use, and b) determine the safety, feasibility, and acceptability of at-home taVNS in five stroke survivors with unilateral upper limb motor deficits. Investigators hypothesize that our lab-based validation will facilitate an optimized home intervention. Furthermore, investigators hypothesize taVNS will be safe and feasible to self-administer in the at-home setting. Lastly, investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials
Interventions
DEVICERemote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training
Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
Sponsors
Medical University of South Carolina
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior; * Ability to give consent; * Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks; * active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks; * Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.
Exclusion criteria
* Other concomitant neurological disorders affecting upper extremity motor function; * Presence of Dysphagia or aspiration difficulties; * Prior injury to vagus nerve; * Pregnancy; * 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; * Botox injections within 4 weeks of the first day of rehabilitation therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Dropped Out | 2 weeks | Dropout rates will be assessed over the course of the study. |
| Adverse Events | 2 weeks | Any side effects or adverse events will be assessed. |
| Mean Participant Compliance With Prescribed At-Home Sessions | 2 weeks | Compliance defined as the percentage of prescribed at-home transcutaneous auricular vagus nerve stimulation (taVNS) paired with task-specific training sessions completed by each participant during the 2-week intervention (6 sessions per participant). |
| Feasibility of Independent Completion of At-Home Study Procedures | 2 weeks | Feasibility was assessed during each remotely supervised at-home session using a 3-point assistance scale evaluating the participant's ability to independently complete study procedures at home. Ratings were assigned as follows: 1 = no assistance required, 2 = minimal assistance required, and 3 = maximum assistance required. Lower scores indicate greater participant independence and greater feasibility of at-home administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Supervised At-Home Sessions Meeting Prespecified Feasibility Criteria | 2 weeks | Feasibility was defined as the proportion of supervised at-home sessions that met both prespecified criteria: (1) completion of greater than 80% of prescribed motor rehabilitation activities and (2) receipt of at least 45 minutes of transcutaneous auricular vagus nerve stimulation during the session. |
| Motor Function- Fugl-Meyer Assessment | 2 weeks | Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Fugl-Meyer Assessment (FMA). |
| Motor Function- Wolf Motor Function | 2-weeks | Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Wolf Motor Function Test. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBashar Badran, PhD
Medical University of South Carolina
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Motor Function- Fugl-Meyer Assessment | 41.4 FMA-UE score STANDARD_DEVIATION 10.09 |
| Motor Function- Wolf Motor Function | 42.6 Wolf Motor Function Test Score STANDARD_DEVIATION 14.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
None listed