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VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

Primary Purpose

Stroke, Upper Limb Deficits

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vagus Nerve Stimulation (VNS)

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Minnesota
UT Southwestern
UT Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vagus Nerve Stimulation (VNS) + Rehabilitation (1)

Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator

Arm Description

This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02243020

First Posted

September 15, 2014

Last Updated

August 22, 2022

Sponsor

MicroTransponder Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02243020

Brief Title

VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MicroTransponder Inc.

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Upper Limb Deficits

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vagus Nerve Stimulation (VNS) + Rehabilitation (1)

Arm Type

Experimental

Arm Description

This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.

Arm Title

Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Vagus Nerve Stimulation (VNS)

Other Intervention Name(s)

VNS

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patty Smith, Ph.D.

Organizational Affiliation

UT Southwestern

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

UT Southwestern

City

Dallas

State/Province

Texas

Country

United States

Facility Name

UT Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30355189

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. 2018 Nov;49(11):2789-2792. doi: 10.1161/STROKEAHA.118.022279.

Results Reference

result

PubMed Identifier

31903435

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 Stroke J. 2019 Dec;4(4):363-377. doi: 10.1177/2396987319855306. Epub 2019 Jun 17.

Results Reference

result

PubMed Identifier

31685853

Citation

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/s41598-019-52092-x.

Results Reference

result

PubMed Identifier

32476617

Citation

Dawson J, Engineer ND, Prudente CN, Pierce D, Francisco G, Yozbatiran N, Tarver WB, Casavant R, Kline DK, Cramer SC, Van de Winckel A, Kimberley TJ. Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up. Neurorehabil Neural Repair. 2020 Jul;34(7):609-615. doi: 10.1177/1545968320924361. Epub 2020 Jun 1.

Results Reference

derived

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VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

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