Clinical trial NCT05694663: Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
Official title: Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Ischemic Stroke
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl Meyer Assessment - Upper Extremity (FMA-UE)
timeFrame: Baseline up to day 390
Secondary outcomes:
measure: Fugl-Meyer Assessment - Lower Extremities (FMA-LE)
timeFrame: Baseline up to day 390
measure: Wolf Motor Function Test (WMFT)
timeFrame: Baseline up to day 390
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline up to day 390
measure: Modified Ranking Score (mRS)
timeFrame: Baseline up to day 390
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Baseline up to day 390
measure: Stroke Impact Scale (SIS)
timeFrame: Baseline up to day 390
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline up to day 390
measure: Patient Reported Outcomes Measurement Information System 29 version 2.1 (PROMIS-29 v2.1) Score
timeFrame: Baseline up to day 390
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline up to day 390
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Christopher P Kellner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: David Putrino, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Fedor Panov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Jenna Tosto, PT, DPT, NCS
role: PRINCIPAL_INVESTIGATOR
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