Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry (VALOR)

November 20, 2023 updated by: Christopher P Kellner, Icahn School of Medicine at Mount Sinai
Vagal Nerve Stimulation is a novel proven therapy for patients with chronic ischemic stroke. The primary objective of this registry is to assess the safety of vagal nerve stimulation for stroke recovery through monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. This registry will monitor patients undergoing VNS for stroke recovery in the Mount Sinai Health System and collect clinical and procedural details, objective outcomes, and patient-reported outcomes associated with vagal nerve stimulation for stroke recovery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Vagal Nerve Stimulation device implantation is a common, standardized neurosurgical procedure that has been performed for over two decades for the treatment of epilepsy and depression and has recently been approved for chronic ischemic stroke. The intended purpose of this registry is to monitor the safety, feasibility, and efficacy of vagal nerve stimulation for stroke recovery. This will be accomplished by monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. The secondary objectives of this study focus on the feasibility and efficacy of employing vagal nerve stimulation for ischemic stroke recovery, as well as obtaining qualitative data on the experience associated with stroke rehabilitation paired with VNS. Additional research questions regarding vagal nerve stimulation for stroke recovery may be addressed as well.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10128
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • Fedor Panov, MD
        • Principal Investigator:
          • Christopher P Kellner, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Putrino, PT, PhD
        • Principal Investigator:
          • Jenna Tosto, PT, DPT, NCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will enroll adult patients with a history of ischemic stroke and upper extremity weakness who plan to undergo vagal nerve stimulation (VNS) implantation.

Description

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all procedures in the VNS-Enhanced Stroke Recovery Program
  • Aged 18 or older
  • History of ischemic stroke
  • Upper extremity weakness
  • Planned to undergo VNS implantation

Exclusion Criteria:

  • Unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, prior injury to the vagus nerve etc.).
  • Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients Undergoing Vagal Nerve Stimulation for Stroke Recovery

Individuals undergoing vagal nerve stimulation (VNS) paired rehabilitation will be included in this cohort.

This is a registry study with no active intervention outside standard of care. Patients with chronic ischemic stroke will be implanted with the Vivistim vagal nerve stimulation device per standard of care.
Device: Vivistim
After one month of prehabiliatory training, the patient will then undergo surgical placement of the implantable VNS device (Vivistim System) consisting of an implantable neurostimulator and an implantable lead and electrode per standard of care. The device comes with a controller and software system which allows for control of the stimulation settings during the rehabilitation phase. The PMA number for this device is 210007 and the date of FDA notice of approval occurred on August 27, 2021.
Other Names:
  • Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl Meyer Assessment - Upper Extremity (FMA-UE)
Time Frame: Baseline up to day 390

The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index for the upper extremities. It is designed to assess motor functioning in patients with post-stroke hemiplegia of the upper limbs.

Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. The total scores range from 0-66, where higher scores indicate better performance.
Baseline up to day 390

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment - Lower Extremities (FMA-LE)
Time Frame: Baseline up to day 390

The Fugl-Meyer Assessment - Lower Extremity (FMA-LE) is a stroke-specific, performance-based impairment index for the lower extremities. It is designed to assess motor functioning in patients with post-stroke hemiplegia of the lower limbs.

Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. The total scores range from 0-34, where higher scores indicate greater performance.
Baseline up to day 390
Wolf Motor Function Test (WMFT)
Time Frame: Baseline up to day 390
The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks. The total score range is 0-75 and the items are rated on a 6-point scale from 0-5. Lower scores are indicative of lower functioning levels.
Baseline up to day 390
Action Research Arm Test (ARAT)
Time Frame: Baseline up to day 390
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, higher scores will indicate better performance
Baseline up to day 390
Modified Ranking Score (mRS)
Time Frame: Baseline up to day 390
The Modified Rankin Score (mRS) is a disability scale with a total score of 6 points. Possible scores range from 0 to 5 with a high score indicating a higher level of disability. A separate category of 6 is usually added for patients who expire.
Baseline up to day 390
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: Baseline up to day 390
The National Institutes of Health Stroke Scale (NIHSS) is used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Total score range from 0-42, higher score indicates lower health outcome.
Baseline up to day 390
Stroke Impact Scale (SIS)
Time Frame: Baseline up to day 390
The Stroke Impact Scale (SIS) is a self-reported questionnaire that evaluates disability and health-related quality of life after stroke. The total score ranges from 0-100 points, and a lower score indicates a greater level of disability.
Baseline up to day 390
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline up to day 390
The Montreal Cognitive Assessment (MoCA) is a screening test used by healthcare providers for the detection of mild cognitive impairment. The scores range between 0-30 points; a score of 26 or above is considered normal cognitive function. Higher values represent a better outcome.
Baseline up to day 390
Patient Reported Outcomes Measurement Information System 29 version 2.1 (PROMIS-29 v2.1) Score
Time Frame: Baseline up to day 390
PROMIS tools were developed to be disease non-specific measures of health-related domains such as self-efficacy for symptom and medication management, depression, anxiety, fatigue, pain interference, sleep disturbance, and physical functioning. The answers are scored from 1-5 and the sum of PROMIS scores results in a raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.
Baseline up to day 390
Beck Depression Inventory (BDI)
Time Frame: Baseline up to day 390
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scoring is from 0 (minimal) to 3 (sever), with total score range from 0-63. A higher score indicates more depressive symptoms. The following score interpretations are provided in the scale's manual: 0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression.
Baseline up to day 390

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Christopher P Kellner, MD, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Fedor Panov, MD, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Jenna Tosto, PT, DPT, NCS, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: David Putrino, PT, PhD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-22-00939

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In order to minimize any privacy risks to the patients participating, IPD data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

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