VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vagus Nerve Stimulation (VNS) + Rehabilitation (1) This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. |
Device: Vagus Nerve Stimulation (VNS)
Other Names:
|
| Active Comparator: 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. |
Device: Vagus Nerve Stimulation (VNS)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior
-
Age >30 years and <80 years
-
Right or left sided weakness of upper extremity
-
UEFM score within designated range.
-
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:
-
History of hemorrhagic stroke
-
Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands.
-
Significant sensory loss.
-
Presence of ongoing dysphagia or aspiration difficulties.
-
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.
-
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.
-
Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy)
-
Severe depression
-
Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)
-
Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
-
Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse)
-
Pregnant or plan on becoming pregnant or breastfeeding during the study period
-
Currently require, or likely to require, diathermy during the study duration
-
Any health problem requiring surveillance with MRI imaging
-
Active rehabilitation within 4-weeks prior to therapy
-
Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy
-
Severe spasticity of the upper limb
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 2 | UT Southwestern | Dallas | Texas | United States | |
| 3 | UT Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- MicroTransponder Inc.
Investigators
- Principal Investigator: Patty Smith, Ph.D., UT Southwestern
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MT-St-02
Study Results
Participant Flow
| Recruitment Details | Recruitment was from January 2016 through August 2017 at 3 US and 1 UK sites. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator |
|---|---|---|
| Arm/Group Description | This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. Vagus Nerve Stimulation (VNS) | 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) |
| Period Title: Overall Study | ||
| STARTED | 8 | 9 |
| COMPLETED | 8 | 9 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | Total |
|---|---|---|---|
| Arm/Group Description | This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. Vagus Nerve Stimulation (VNS) | 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) | Total of all reporting groups |
| Overall Participants | 8 | 9 | 17 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
59.5
(7.4)
|
60.0
(13.5)
|
59.8
(10.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
50%
|
4
44.4%
|
8
47.1%
|
| Male |
4
50%
|
5
55.6%
|
9
52.9%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
4
50%
|
5
55.6%
|
9
52.9%
|
| United Kingdom |
4
50%
|
4
44.4%
|
8
47.1%
|
| Time Since Stroke (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
1.5
(.7)
|
1.5
(.3)
|
1.5
(.5)
|
| Baseline Upper Extremity Fugl-Meyer (UEFM) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
29.5
(6.4)
|
36.4
(9.4)
|
33.2
(8.0)
|
Outcome Measures
| Title | Change in Upper Extremity Fugl-Meyer (UEFM) |
|---|---|
| Description | Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed. |
| Time Frame | 6-weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator |
|---|---|---|
| Arm/Group Description | This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. Vagus Nerve Stimulation (VNS) | 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) |
| Measure Participants | 8 | 9 |
| Mean (Standard Deviation) [units on a scale] |
7.6
(4.8)
|
5.3
(3.2)
|
| Title | Change in Wolf Motor Function Test Functional Assessment (WMFT) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator |
|---|---|---|
| Arm/Group Description | This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. Vagus Nerve Stimulation (VNS) | 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) |
| Measure Participants | 8 | 9 |
| Mean (Standard Deviation) [units on a scale] |
0.25
(0.24)
|
.13
(.17)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | ||
| Arm/Group Description | This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. Vagus Nerve Stimulation (VNS) | 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) | ||
All Cause Mortality |
||||
| Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 3/9 (33.3%) | ||
| Infections and infestations | ||||
| Wound Infection | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Shortness of Breath and Dysphagia | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
| Hoarseness | 0/8 (0%) | 0 | 1/9 (11.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/8 (50%) | 4/9 (44.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Pain/Bruising from implant surgery | 4/8 (50%) | 4 | 4/9 (44.4%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | VP Clinical Affairs |
|---|---|
| Organization | MicroTransponder Inc. |
| Phone | 5123714160 |
| brent@microtransponder.com |
- MT-St-02