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Stroke, AcuteNCT04088578

VNS-supplemented Motor Retraining After Stroke

A study testing Training and Vagus Nerve Stimulation in people with Stroke, Acute, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Acute
What is being tested?
Training and Vagus Nerve Stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
22 Sep 2019to 9 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Mechanisms of Non-invasive Vagus Nerve Stimulation Underlying Enhanced Motor Control in Humans

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.

Read the 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.

Conditions
Stroke, Acute
Being tested
Training, Vagus Nerve Stimulation, Sham Stimulation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrainingOther

    Controlling movement of an object on computer screen by adjusting muscle activity.

  • Vagus Nerve StimulationOther

    Also called VNS

    Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.

  • Sham StimulationOther

    Also called Sham

    Sub-threshold stimulation that does not activate neural structures.

Study groups in NCT04088578
Study groupRoleWhat they receive
Vagus nerve stimulation (VNS)ExperimentalStroke 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.
Receives: Other: Training; Other: Vagus Nerve Stimulation
Sham stimulationSham comparatorStroke 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.
Receives: Other: Training; Other: Sham Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start22 Sep 2019
  3. Primary completion9 Nov 2021
  4. Study completion9 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04088578
Sponsor's protocol ID
STUDY19040394 (Aim 2)
Status last verified
Oct 2022
First submitted
9 Sep 2019
Last updated
1 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 8172497

  • 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.

    PubMed 22341029

  • 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.

    PubMed 19608100

  • 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.

    PubMed 21262990

  • 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.

    PubMed 22079923

  • 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.

    PubMed 23954448

  • 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.

    PubMed 24553102

  • 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.

    PubMed 29371435

  • 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.

    PubMed 26645257

  • 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.

    PubMed 29562561

  • 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.

    PubMed 30355189

Questions about this trial

What is this clinical trial studying?

A study testing Training and Vagus Nerve Stimulation in people with Stroke, Acute, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in time-on-target score. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04088578, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.

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