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taVNS for Upper Limb Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129242
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : January 23, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Bashar Badran, Medical University of South Carolina

Brief Summary:
This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients. Patients will undergo a series of baseline assessments (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments (including a second brain scan)

Condition or disease Intervention/treatment Phase
Stroke Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training Early Phase 1

Detailed Description:

This study aims to refine and develop closed loop taVNS, establish activity with key biomarkers, and show initial feasibility in a small clinical trial. For paired taVNS to succeed as a clinical treatment, it is critical to develop and refine a closed-loop taVNS platform that delivers stimulation concurrently during specific movements of the motor rehabilitation training.

Aim 1 develops this novel motion-gated closed-loop system that delivers taVNS in synchrony with specific upper limb motor activation (n=5) Aim 2 will combine the development of the closed-loop system with the investigator's mechanistic understanding to explore an open-label pilot trial (n=20) using closed-loop taVNS paired with task-specific training to determine the feasibility, safety, and potential effect size of this novel combination therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimization of Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) as a Neurorehabilitation Tool
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: "paired" taVNS + Task Specific Training Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training
A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.

Active Comparator: "unpaired" taVNS + Task Specific Training Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training
A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.




Primary Outcome Measures :
  1. Change in Fugl-Meyer Assessment of the Upper Extremity [ Time Frame: Participants will be assessed weekly for the duration of the 4-week intervention, followed by 2 and 8 weeks post intervention. ]
    The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Possible aggregate scores range from 0/66 to 66/66 points. Higher scores indicate greater levels of arm movement ability.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-80 years old
  • First-ever ischemic stroke that occurred at least 6 months prior
  • Completed conventional rehabilitation therapy at least one month prior
  • Unilateral limb weakness with Fugl Meyer-Upper Extremity Scale score less than or equal to 58 (out of 66)
  • Inducible MEPs (Motor Evoked Potentials) by TMS (Transcranial Magnetic Stimulation) on abductor pollicis brevis (APB) muscle on the paretic limb (intact corticospinal tract).

Exclusion Criteria:

  • Primary intracerebral hematoma, or subarachnoid hemorrhage
  • Bihemispheric ischemic stroke
  • History of prior stroke or old infarct demonstrated on the CT or MRI or documented in medical records
  • Other concomitant neurological disorders affecting upper extremity motor function
  • Documented history of dementia before or after stroke
  • Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment
  • Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) >=180/100mmHg at baseline
  • Contraindicated for MRI scanning.

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): NCT04129242


Contacts
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Contact: Bashar Badran, PhD 843-792-6076 badran@musc.edu
Contact: Andrew Fortune, BS 843-792-8970 fortunea@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Bashar W Badran, PhD       badran@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)

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Responsible Party: Bashar Badran, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04129242    
Other Study ID Numbers: 00086291
2P20GM109040 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bashar Badran, Medical University of South Carolina:
Stroke
Rehabilitation
Vagus Nerve Stimulation
Brain Stimulation
Occupational Therapy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases