Stroke, Upper Limb Deficits
Conditions
Brief summary
The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.
Interventions
Sponsors
MicroTransponder Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior 2. Age \>30 years and \<80 years 3. Right or left sided weakness of upper extremity 4. UEFM score within designated range. 5. At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits
Exclusion criteria
1. History of hemorrhagic stroke 2. Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands. 3. Significant sensory loss. 4. Presence of ongoing dysphagia or aspiration difficulties. 5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy. 6. Subject receiving any therapy (medication or otherwise) at study entry that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms). Additionally, no psychoactive medications - including nicotine - may be used during the acute study. 7. Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy) 8. Severe depression 9. Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.) 10. Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug 11. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) 12. Pregnant or plan on becoming pregnant or breastfeeding during the study period 13. Currently require, or likely to require, diathermy during the study duration 14. Any health problem requiring surveillance with MRI imaging 15. Active rehabilitation within 4-weeks prior to therapy 16. Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy 17. Severe spasticity of the upper limb
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Fugl-Meyer (UEFM) | 6-weeks | Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wolf Motor Function Test Functional Assessment (WMFT) | 6-weeks | Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome. |
Countries
United States
Participant flow
Recruitment details
Recruitment was from January 2016 through August 2017 at 3 US and 1 UK sites.
Participants by arm
| Arm | Count |
|---|---|
| Vagus Nerve Stimulation (VNS) + Rehabilitation (1) This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
Vagus Nerve Stimulation (VNS) | 8 |
| Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
Vagus Nerve Stimulation (VNS) | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | Total |
|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 7.4 | 60.0 years STANDARD_DEVIATION 13.5 | 59.8 years STANDARD_DEVIATION 10.5 |
| Baseline Upper Extremity Fugl-Meyer (UEFM) | 29.5 units on a scale STANDARD_DEVIATION 6.4 | 36.4 units on a scale STANDARD_DEVIATION 9.4 | 33.2 units on a scale STANDARD_DEVIATION 8 |
| Region of Enrollment United Kingdom | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment United States | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
| Time Since Stroke | 1.5 years STANDARD_DEVIATION 0.7 | 1.5 years STANDARD_DEVIATION 0.3 | 1.5 years STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 8 | 4 / 9 |
| serious Total, serious adverse events | 0 / 8 | 3 / 9 |
Outcome results
Primary
Change in Upper Extremity Fugl-Meyer (UEFM)
Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.
Time frame: 6-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Change in Upper Extremity Fugl-Meyer (UEFM) | 7.6 units on a scale | Standard Deviation 4.8 |
| Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | Change in Upper Extremity Fugl-Meyer (UEFM) | 5.3 units on a scale | Standard Deviation 3.2 |
Secondary
Change in Wolf Motor Function Test Functional Assessment (WMFT)
Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.
Time frame: 6-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Change in Wolf Motor Function Test Functional Assessment (WMFT) | 0.25 units on a scale | Standard Deviation 0.24 |
| Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | Change in Wolf Motor Function Test Functional Assessment (WMFT) | .13 units on a scale | Standard Deviation 0.17 |