VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

Stroke Clinical Trial

Official title:

Study MT-St-02 - Stroke - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (MicroTransponder's Vivistim System)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243020
• Other study ID #: MT-St-02
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2022
• Source: MicroTransponder Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 1, 2022
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Upper Limb Deficits

Intervention

Device:
• Vagus Nerve Stimulation (VNS)

Locations

Country	Name	City	State
United States	UT Southwestern	Dallas	Texas
United States	UT Houston	Houston	Texas
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
MicroTransponder Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dickie DA, Kimberley TJ, Pierce D, Engineer N, Tarver WB, Dawson J. An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke. Sci Rep. 2019 Nov 4;9(1):15902. doi: 10.1038/s41598- — View Citation

Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2 — View Citation

Kimberley TJ, Prudente CN, Engineer ND, Pierce D, Tarver B, Cramer SC, Dickie DA, Dawson J. Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke. Eur Stro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6-weeks
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.	6-weeks