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VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

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ClinicalTrials.gov Identifier: NCT02243020
Recruitment Status : Active, not recruiting
First Posted : September 17, 2014
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
MicroTransponder Inc.

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
Stroke Upper Limb Deficits Device: Vagus Nerve Stimulation (VNS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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 Name: VNS

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 Name: VNS




Primary Outcome Measures :
  1. Change in Upper Extremity Fugl-Meyer (UEFM) [ Time Frame: 6-weeks ]
    Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.


Secondary Outcome Measures :
  1. Change in Wolf Motor Function Test Functional Assessment (WMFT) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243020


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Texas
UT Southwestern
Dallas, Texas, United States
UT Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
MicroTransponder Inc.
Investigators
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Principal Investigator: Patty Smith, Ph.D. UT Southwestern

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT02243020     History of Changes
Other Study ID Numbers: MT-St-02
First Posted: September 17, 2014    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases