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VNS-supplemented Motor Retraining After Stroke

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training
Vagus Nerve Stimulation
Sham Stimulation
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

INDIVIDUALS WHO HAVE HAD A STROKE:

  1. Diagnosis of first ever stroke
  2. At least 6 months after stroke onset
  3. Motor-evoked potentials in hand/arm muscles

  4. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.

    ALL INDIVIDUALS:

  5. Between the ages of 18 and 75 years old

Exclusion Criteria:

INDIVIDUALS WHO HAVE HAD A STROKE:

  1. Hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators

    ALL INDIVIDUALS:

  2. Neurological disorder(s) influencing movement (besides stroke)
  3. History of seizure or epilepsy
  4. Metallic brain implants
  5. Bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers
  6. Pregnant or expecting to become pregnant
  7. Difficulty maintaining alertness and/or remaining still
  8. Silicone or plastic allergy
  9. History of vestibular disorders (eg, Vertigo, Meniere's Disease, etc.)

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Vagus nerve stimulation (VNS)

Sham stimulation

Arm Description

Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. VNS will be delivered when a minimum level of accuracy has been achieved.

Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. Sham stimulation will be delivered when a minimum level of accuracy has been achieved.

Outcomes

Primary Outcome Measures

Change in time-on-target score.
The score reflects the total time the object overlaps any part of targets, expressed as a percentage (0-100) of the total possible time. Thus, a score of 0 is the worst possible score, whereas, 100 is the best possible score. The primary endpoint is the change from baseline (ie, before training) in the time-on-target score.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2019
Last Updated
October 31, 2022
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT04088578
Brief Title
VNS-supplemented Motor Retraining After Stroke
Official Title
Mechanisms of Non-invasive Vagus Nerve Stimulation Underlying Enhanced Motor Control in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2019 (Actual)
Primary Completion Date
November 9, 2021 (Actual)
Study Completion Date
November 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.
Detailed Description
To establish a link between the physiological mechanisms driving enhanced motor control in response to VNS, subjects will undergo progressive training on a visuomotor task that requires fine gradation of voluntary motor output to control a moving object through target boundaries. In separate groups, VNS or sham stimulation will be paired with movement when a minimal time-on-target (ToT) is achieved.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vagus nerve stimulation (VNS)
Arm Type
Experimental
Arm Description
Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. VNS will be delivered when a minimum level of accuracy has been achieved.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. Sham stimulation will be delivered when a minimum level of accuracy has been achieved.
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
Controlling movement of an object on computer screen by adjusting muscle activity.
Intervention Type
Other
Intervention Name(s)
Vagus Nerve Stimulation
Other Intervention Name(s)
VNS
Intervention Description
Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.
Intervention Type
Other
Intervention Name(s)
Sham Stimulation
Other Intervention Name(s)
Sham
Intervention Description
Sub-threshold stimulation that does not activate neural structures.
Primary Outcome Measure Information:
Title
Change in time-on-target score.
Description
The score reflects the total time the object overlaps any part of targets, expressed as a percentage (0-100) of the total possible time. Thus, a score of 0 is the worst possible score, whereas, 100 is the best possible score. The primary endpoint is the change from baseline (ie, before training) in the time-on-target score.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: INDIVIDUALS WHO HAVE HAD A STROKE: Diagnosis of first ever stroke At least 6 months after stroke onset Motor-evoked potentials in hand/arm muscles Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators. ALL INDIVIDUALS: Between the ages of 18 and 75 years old Exclusion Criteria: INDIVIDUALS WHO HAVE HAD A STROKE: Hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators ALL INDIVIDUALS: Neurological disorder(s) influencing movement (besides stroke) History of seizure or epilepsy Metallic brain implants Bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers Pregnant or expecting to become pregnant Difficulty maintaining alertness and/or remaining still Silicone or plastic allergy History of vestibular disorders (eg, Vertigo, Meniere's Disease, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George F Wittenberg, MD, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The research team may share data with scientists at other centers for the purpose of data analysis and collaboration. Research information and data may be shared with investigators conducting other research. This information will not be identifiable.
IPD Sharing Time Frame
Information may be shared while data is being recorded, analyzed, and/or prior to publication. Data may be available for seven years after manuscripts are published.
IPD Sharing Access Criteria
Data use agreements will be established with scientists at other centers, or conducting other research, prior to any data sharing.
Citations:
PubMed Identifier
8172497
Citation
Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9.
Results Reference
background
PubMed Identifier
22341029
Citation
Pollock A, St George B, Fenton M, Firkins L. Top ten research priorities relating to life after stroke. Lancet Neurol. 2012 Mar;11(3):209. doi: 10.1016/S1474-4422(12)70029-7. No abstract available.
Results Reference
background
PubMed Identifier
19608100
Citation
Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.
Results Reference
background
PubMed Identifier
21262990
Citation
Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.
Results Reference
background
PubMed Identifier
22079923
Citation
Porter BA, Khodaparast N, Fayyaz T, Cheung RJ, Ahmed SS, Vrana WA, Rennaker RL 2nd, Kilgard MP. Repeatedly pairing vagus nerve stimulation with a movement reorganizes primary motor cortex. Cereb Cortex. 2012 Oct;22(10):2365-74. doi: 10.1093/cercor/bhr316. Epub 2011 Nov 10.
Results Reference
background
PubMed Identifier
23954448
Citation
Khodaparast N, Hays SA, Sloan AM, Hulsey DR, Ruiz A, Pantoja M, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves forelimb strength following ischemic stroke. Neurobiol Dis. 2013 Dec;60:80-8. doi: 10.1016/j.nbd.2013.08.002. Epub 2013 Aug 15.
Results Reference
background
PubMed Identifier
24553102
Citation
Khodaparast N, Hays SA, Sloan AM, Fayyaz T, Hulsey DR, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation delivered during motor rehabilitation improves recovery in a rat model of stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):698-706. doi: 10.1177/1545968314521006. Epub 2014 Feb 18.
Results Reference
background
PubMed Identifier
29371435
Citation
Meyers EC, Solorzano BR, James J, Ganzer PD, Lai ES, Rennaker RL 2nd, Kilgard MP, Hays SA. Vagus Nerve Stimulation Enhances Stable Plasticity and Generalization of Stroke Recovery. Stroke. 2018 Mar;49(3):710-717. doi: 10.1161/STROKEAHA.117.019202. Epub 2018 Jan 25.
Results Reference
background
PubMed Identifier
26645257
Citation
Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
Results Reference
background
PubMed Identifier
29562561
Citation
Kilgard MP, Rennaker RL, Alexander J, Dawson J. Vagus nerve stimulation paired with tactile training improved sensory function in a chronic stroke patient. NeuroRehabilitation. 2018;42(2):159-165. doi: 10.3233/NRE-172273.
Results Reference
background
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
background

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VNS-supplemented Motor Retraining After Stroke

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