Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke
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|ClinicalTrials.gov Identifier: NCT01669161|
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : October 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Vivistim System Other: Rehab Only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Rehabilitation for Improved Upper Limb Function After Stroke (MicroTransponder's Vivistim System)|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||December 2014|
VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.
Device: Vivistim System
The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.
Other Name: VNS, vagus nerve stimulation, paired VNS
Active Comparator: Rehab Only
Rehabilitation only (no implant, no VNS)
Other: Rehab Only
Rehabilitation without device implant and VNS
- Safety [ Time Frame: 6-weeks ]Assessment of adverse events and serious adverse events.
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): NCT01669161
|U. Glasgow / Western Infirmary|
|Glasgow, Scotland, United Kingdom|
|Principal Investigator:||Jesse Dawson, MD||U. Glasgow|