Abstract Details

Title Vagus Nerve Stimulation Paired with Upper Extremity Rehabilitation After Chronic Stroke: Cross-over results from the VNS-REHAB Pivotal Study

Topic Neuro-rehabilitation

Presentation(s) Emerging Science Session (3:17 PM-3:21 PM)

Poster/Presentation
Number 004

Background

A recent randomized, blinded, controlled, trial of 108 people with upper extremity weakness at least 9 months after ischemic stroke, demonstrated significant improvements in impairment and function following rehabilitation paired with VNS compared to rehabilitation paired with sham VNS.

Objective

To test the efficacy of Vagus Nerve Stimulation (VNS) paired with upper extremity rehabilitation after chronic stroke compared to rehabilitation paired with sham VNS.

Design/Methods

Participants received 6 weeks of in-clinic intense rehabilitation followed by a 3-month home exercise program that marked the conclusion of blinded follow-up. Thereafter, sham VNS participants crossed over to receive 6 weeks of VNS-paired in-clinic rehabilitation (n=47) followed by a 3-month home exercise program (n=41). The results of this crossover phase are presented here and full statistical analysis will be available for the meeting. Fugl-Meyer Upper Extremity (FMA-UE, primary outcome) and Wolf-Motor Function Test (WMFT) scores were assessed pre-randomization, after sham VNS and then again after crossover.

Results

During sham VNS, participants’ FMA-UE score increased from 35.6 (SD 8.1) at baseline to 38.7 (SD 9.8) after the home exercise period. Following crossover to active VNS + rehabilitation, the FMA-UE score increased further to 41.6 (SD 9.8). It was 40.9 (SD 10.6) after the home exercise period. During sham VNS, participants’ WMFT score increased by 0.4 points (SD 0.5). During active VNS, the WMFT score increased by a further 0.2 points (SD 0.4). Ten (24%) and 14 (34%) people exceeded the minimal clinically important difference for FMA-UE (≥ 6 points) and WMFT (≥ 0.4 points) respectively following active VNS. No related adverse or serious adverse events were reported during crossover.

Conclusions

Participants who initially received sham VNS + rehabilitation exhibited further improvements once they received a course of active VNS paired with rehabilitation. Overall, these participants experienced similar improvements to those who were initially randomized to active VNS group.

Authors/Disclosures
Jesse Dawson PRESENTER	Jesse Dawson, 12284 has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Astra Zeneca. Jesse Dawson, 12284 has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. Jesse Dawson, 12284 has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pfizer. Jesse Dawson, 12284 has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS. Jesse Dawson, 12284 has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boeringher Ingelheim. Jesse Dawson, 12284 has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic.
	No disclosure on file
	No disclosure on file
Steven C. Cramer, MD, FAAN	Dr. Cramer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Constant Therapeutics, BrainQ, Myomo, MicroTransponder, Panaxium, Beren Therapeutics, Medtronic, Stream Biomedical, NeuroTrauma Sciences, and TRCare. . Dr. Cramer has stock in Constant Therapeutics, Panaxium, and TRCare. The institution of Dr. Cramer has received research support from NIH; PCORI; Veterans Administration.
Steven Wolf, PhD, PT (Emory University School of Medicine)	Steven Wolf, PhD,PT has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Microtransponer. Steven Wolf, PhD,PT has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Enspire.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Leigh R. Hochberg, MD, PhD, FAAN (Massachusetts General Hospital)	The institution of Dr. Hochberg has received research support from The MGH Translational Research Center has a clinical research support agreement (CRSA) with Axoft, Neuralink, Neurobionics, Precision Neuro, Synchron, and Reach Neuro, for which LRH provides consultative input. LRH is a non-compensated member of the Board of Directors of a nonprofit assistive communication device technology foundation (Speak Your Mind Foundation). Mass General Brigham (MGB) is convening the Implantable Brain-Computer Interface Collaborative Community (iBCI-CC); charitable gift agreements to MGB, including those received to date from Paradromics, Synchron, Precision Neuro, Neuralink, and Blackrock Neurotech, support the iBCI-CC, for which LRH provides effort.. The institution of Dr. Hochberg has received research support from Dr. Hochberg also receives research support from the US Department of Veterans Affairs and the National Institutes of Health.. Dr. Hochberg has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
Arshad Majid, MD	Dr. Majid has received publishing royalties from a publication relating to health care.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Navzer Engineer, PhD (MicroTransponder)	Dr. Engineer has received personal compensation for serving as an employee of MicroTransponder. Dr. Engineer has received stock or an ownership interest from MicroTransponder. Dr. Engineer has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file

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