NCT02243020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

May 15, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 15, 2022

Status Verified

August 1, 2022

Enrollment Period

2.2 years

First QC Date

September 15, 2014

Results QC Date

April 24, 2018

Last Update Submit

August 22, 2022

Conditions

StrokeUpper Limb Deficits

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Wolf Motor Function Test Functional Assessment (WMFT)

    6-weeks

Study Arms (2)

Vagus Nerve Stimulation (VNS) + Rehabilitation (1)

EXPERIMENTAL

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

Device: Vagus Nerve Stimulation (VNS)

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

ACTIVE 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)

Interventions

Vagus Nerve Stimulation (VNS)DEVICE
Also known as: VNS
Vagus Nerve Stim (VNS) + Rehabilitation (2) - ComparatorVagus Nerve Stimulation (VNS) + Rehabilitation (1)

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

UT Southwestern

Dallas, Texas, United States

Location

UT Houston

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • 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.

    PMID: 30355189RESULT

  • 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.

    PMID: 31903435RESULT

  • 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.

    PMID: 31685853RESULT

  • 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.

    PMID: 32476617DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Results Point of Contact

Title
VP Clinical Affairs
Organization
MicroTransponder Inc.
brent@microtransponder.com
5123714160

Study Officials

  • Patty Smith, Ph.D.

    UT Southwestern

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 17, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

June 1, 2022

Last Updated

September 15, 2022

Results First Posted

May 15, 2019

Record last verified: 2022-08

Locations

US(3)