Stroke
Conditions
Keywords
Stroke, Rehabilitation, Vagus Nerve Stimulation, Brain Stimulation, Occupational Therapy
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.
Interventions
DEVICETranscutaneous 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.
Sponsors
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer Assessment of the Upper Extremity | Mean change in FMA-UE score after 4 weeks of rehab, compared to baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paired taVNS + Task Specific Training 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. | 9 |
| Unpaired taVNS + Task Specific Training 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. | 7 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Paired taVNS + Task Specific Training | Unpaired taVNS + Task Specific Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 5 Participants | 13 Participants |
| Age, Continuous | 57.33 years STANDARD_DEVIATION 8.28 | 58.71 years STANDARD_DEVIATION 6.45 | 57.93 years STANDARD_DEVIATION 7.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Mean change in FMA-UE score after 4 weeks of rehab, compared to baseline
Population: Adults with unilateral motor deficits post-stroke
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paired taVNS + Task Specific Training | Change in Fugl-Meyer Assessment of the Upper Extremity | 5 score on a scale | Standard Error 1.02 |
| Unpaired taVNS + Task Specific Training | Change in Fugl-Meyer Assessment of the Upper Extremity | 3.14 score on a scale | Standard Error 0.63 |