Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
ConditionChronic Ischemic Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Vivistim
DeviceAfter 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Patients Undergoing Vagal Nerve Stimulation for Stroke Recovery1 intervention
Trial outcomes
Primary outcomes
1
Fugl Meyer Assessment - Upper Extremity (FMA-UE)
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.
Time frame
Baseline up to day 390Secondary outcomes
1
Fugl-Meyer Assessment - Lower Extremities (FMA-LE)
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.
Time frame
Baseline up to day 3902
Wolf Motor Function Test (WMFT)
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.
Time frame
Baseline up to day 3903
Action Research Arm Test (ARAT)
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
Time frame
Baseline up to day 3904
Modified Ranking Score (mRS)
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.
Time frame
Baseline up to day 390Sponsors and contacts
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Source ClinicalTrials.gov