- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04088578
VNS-supplemented Motor Retraining After Stroke
Mechanisms of Non-invasive Vagus Nerve Stimulation Underlying Enhanced Motor Control in Humans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vagus nerve stimulation (VNS)
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.
|
Controlling movement of an object on computer screen by adjusting muscle activity.
Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.
Other Names:
|
Sham Comparator: Sham stimulation
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.
|
Sub-threshold stimulation that does not activate neural structures.
Other Names:
Controlling movement of an object on computer screen by adjusting muscle activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in time-on-target score.
Time Frame: 3 weeks
|
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.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: George F Wittenberg, MD, PhD, University of Pittsburgh
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19040394 (Aim 2)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke, Acute
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Cidat, S.A. de C.V.El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUnknownStroke | Stroke, Acute | Cerebral Stroke | Cerebrovascular Stroke | Cerebrovascular Accident, AcuteMexico
-
Centre hospitalier de l'Université de Montréal...Not yet recruitingStroke, Acute ThromboticCanada
-
University of MiamiTemporarily not availableStroke, Ischemic | Stroke, Acute | Mesenchymal Stem Cells | Acute Ischemic Stroke | Stroke/Brain AttackUnited States
-
University Hospital, MontpellierNot yet recruiting
-
Capital Medical UniversityRecruitingAcute Stroke | Ischemic Stroke, AcuteChina
-
Chonbuk National University HospitalKorean Society of Neurosonology; Ministry of SMEs and Startups, Republic of... and other collaboratorsCompleted
-
Dongzhimen Hospital, BeijingThe Second Hospital of Hebei Medical University; Peking University Third Hospital and other collaboratorsRecruitingStroke, Ischemic | Stroke, Acute | Acute Ischemic StrokeChina
-
National Taiwan University HospitalCompleted
-
University of EdinburghNHS LothianRecruiting
Clinical Trials on Sham Stimulation
-
National Cheng-Kung University HospitalRecruiting
-
Georgia Institute of TechnologyEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsNot yet recruiting
-
Tianjin Anding HospitalChinese Academy of SciencesEnrolling by invitationSchizophrenia Negative TypeChina
-
Beijing Tiantan HospitalPeking Union Medical College Hospital; China-Japan Friendship Hospital; The First...Unknown
-
Mary Phillips, MD MD (Cantab)National Institute of Mental Health (NIMH)RecruitingBipolar DisorderUnited States
-
Sheba Medical CenterSuspended
-
Christian BaumannETH ZurichRecruitingParkinson Disease | Mild Cognitive Impairment | Huntington DiseaseSwitzerland
-
University of ManitobaRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Paraplegia, Spinal | Paraplegia, IncompleteCanada
-
Dr. med. Carlo CeredaUniversity Hospital Inselspital, Berne; CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE... and other collaboratorsUnknownIschemic Stroke | First Ever Clinical Stroke | Subacute Phase | Persistent Hemiparesis of Upper ExtremitySwitzerland
-
University of BonnRecruiting