Randomized Controlled Trial of Vagal Nerve Stimulation for Younger Pediatric Patients with Intractable Epilepsy

2020 ◽  
Author(s):  
Zhao Yang ◽  
Taoyun Ji ◽  
Qingzhu Liu ◽  
Jianxiang Liao ◽  
Fei Yin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Nerve Stimulation ◽  
Pediatric Patients ◽  
Controlled Trial ◽  
Intractable Epilepsy ◽  
Vagal Nerve ◽  
Vagal Nerve Stimulation ◽  
Randomized Controlled

scholarly journals Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Charles Ethan Paccione ◽  
Lien My Diep ◽  
Audun Stubhaug ◽  
Henrik Børsting Jacobsen
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Heart Rate Variability ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Controlled Trial ◽  
Vagal Nerve ◽  
Randomized Controlled ◽  
Transcutaneous Vagus Nerve Stimulation

Abstract Background Chronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different noninvasive vagal nerve stimulation techniques for the treatment of FM. Methods The study will use a randomized, single-blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRB™) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N = 112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N = 56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N = 56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography-measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life. Discussion The described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited. Trial registration ClinicalTrials.govNCT03180554. Registered on August 06, 2017.

scholarly journals Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Charles Ethan Paccione ◽  
Lien My Diep ◽  
Audun Stubhaug ◽  
Henrik Børsting Jacobsen
Keyword(s):  
Heart Rate ◽  
Randomized Controlled Trial ◽  
Heart Rate Variability ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Controlled Trial ◽  
Vagal Nerve ◽  
Randomized Controlled ◽  
Transcutaneous Vagus Nerve Stimulation

Abstract BackgroundChronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different non-invasive vagal nerve stimulation techniques for the treatment of FM.MethodsThe study will use a randomized, single blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRBTM) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N=112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N=56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N=56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pain-pressure limit determined by computerized pressure cuff algometry, blood pressure, and health related quality of life.DiscussionThe described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited.Trial registrationClinicalTrials.gov Identifier: NCT03180554; Date of Registration: 08/06/2017

Behavioural and cognitive effects during vagus nerve stimulation in children with intractable epilepsy – A randomized controlled trial

2013 ◽  
Vol 17 (1) ◽  
pp. 82-90 ◽  
Author(s):  
Sylvia Klinkenberg ◽  
Charlotte N.C.J. van den Bosch ◽  
H.J. Marian Majoie ◽  
Marlien W. Aalbers ◽  
Loes Leenen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Controlled Trial ◽  
Intractable Epilepsy ◽  
Cognitive Effects ◽  
Randomized Controlled

scholarly journals Vagus nerve stimulation in children with intractable epilepsy: a randomized controlled trial

2012 ◽  
Vol 54 (9) ◽  
pp. 855-861 ◽  
Author(s):  
SYLVIA KLINKENBERG ◽  
MARLIEN W AALBERS ◽  
JOHAN S H VLES ◽  
ERWIN M J CORNIPS ◽  
KIM RIJKERS ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Controlled Trial ◽  
Intractable Epilepsy ◽  
Randomized Controlled
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