Clinical trials: Transcutaneous Vagus Nerve Stimulation
Infant Feeding Problems, taVNS
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding
Feeding is critical for pre-term infants and term infants with hypoxic ischemic brain injury, in order to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement.
- Trial name
- BabyStrong I (NCT04849507)
- Testing
- transcutaneous auricular vagus nerve stimulation
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Medical University of South Carolina
Epilepsy
Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy
The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.
- Trial name
- NCT02004340
- Testing
- ear vagus nerve stimulator
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- China Academy of Chinese Medical Sciences
Transcutaneous Vagal Nerve Stimulation (tVNS), Parkinson Disease (PD)
Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
This study aims to determine whether electrical stimulation of the ear, when combined with physical and speech therapy, can improve symptoms in subjects diagnosed with Parkinson´s disease, by comparing two different application…
- Trial name
- tVNS_PD (NCT07588191)
- Testing
- Transcutaneous Electrical Nerve Stimulation (TENS) of Vagus Nerve, Conventional Physical therapy, Conventional Speech Therapy
- Where
- Spain
- Volunteers
- 46 people
- Sponsor
- Universidade da Coruña
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
Cerebral Palsy
Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS)
The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcutaneous Vagus Nerve Stimulation (tVNS) in enhancing the functional changes due to an intensive motor training in children and…
- Trial name
- (BOOSTTVNS) (NCT06372028)
- Testing
- transcutaneous vagus nerve stimulation (tVNS)
- Where
- Italy
- Volunteers
- 44 people
- Sponsor
- IRCCS Eugenio Medea
Healthy Adults
Does Transcutaneous Vagal Nerve Stimulation Improves Fear Extinction in Humans
A recent study with rats showed that electrical stimulation of the vagus nerve (VNS) facilitates extinction of fear (Pena, Engineer, \& McIntyre, Biological Psychiatry, 2013).
- Trial name
- t-VNSext (NCT02113306)
- Testing
- t-VNS
- Where
- Belgium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Feeding Delays, Neonates and Term Infants
BabySTrong II taVNS Feeding Trial
The long-term goal of this project is to develop a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed so that infants may be discharged home with their families and avoid the…
- Trial name
- BabySTrong II (NCT07049952)
- Testing
- taVNS, NAC and taVNS, inactive taVNS
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Medical University of South Carolina
Prader-Willi Syndrome, Social Behavior
tVNS in Children With Prader-Willi Syndrome
The purpose of the current project is to test the impact of transcutaneous vagus nerve stimulation (tVNS) on social ability in children with Prader-Willi Syndrome (PWS).
- Trial name
- NCT04396470
- Testing
- tVNS
- Sponsor
- Stanford University
Perinatal Brain Injury
Neuro-MoD: Neuroplasticity With Motor Development
This study is for infants and toddlers between 8 and 24 months old who use one arm and/or hand differently following a perinatal brain injury.
- Trial name
- NCT07738432
- Testing
- Constraint-Induced Movement Therapy (CIMT), Transcutaneous auricular vagus nerve stimulation (taVNS)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Wisconsin, Madison
Efficacy, Self, Fatigue; Muscle, Heart
Neuromodulation of the Autonomic Nervous System in Athletes
There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion).
- Conditions
- Efficacy, Self, Fatigue; Muscle, Heart, Fatigue, Mental, Fatigue; Combat
- Trial name
- NANSA (NCT06281795)
- Testing
- tVNS
- Where
- Russia
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Bakulev Scientific Center of Cardiovascular Surgery
Premature Birth, Breastfeeding, Exclusive
taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge
Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation.
- Conditions
- Premature Birth, Breastfeeding, Exclusive, Feeding; Difficult, Newborn
- Trial name
- NCT06417385
- Testing
- taVNS soterix device
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Mild Cognitive Impairment, Neurocardiogenic Syncope
VINCI-AD: An Investigation of Transcutaneous Vagus Nerve Stimulation in Mild Cognitive Impairment.
The VINCI-AD study will investigate the impact of non-invasive vagus nerve stimulation (VNS) on memory in participants with existing mild memory impairment. VNS is a safe, existing treatment, licensed in epilepsy and depression.
- Conditions
- Mild Cognitive Impairment, Neurocardiogenic Syncope, Memory Impairment, Inflammatory Response
- Trial name
- NCT05514756
- Testing
- Active t-VNS, Baseline assessments
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- Tallaght University Hospital
Self Harm, Suicidal Ideation
Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents
Suicidal thoughts, suicide attempts, and suicide are increasingly common in adolescence. Current face-to-face prevention approaches are of limited effectiveness, rely on extensive resources, and are at odds with adolescents'…
- Trial name
- NCT05602779
- Testing
- tVNS Program, Phone App Program, tVNS and Phone App Program
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- University of Notre Dame
Endometriosis
Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia.
- Trial name
- Stim-Endom (NCT04177511)
- Testing
- Transcutaneous Auricular Vagus Nerve Stimulation
- Where
- France
- Volunteers
- 72 people
- Sponsor
- Hopital Foch
Adult
LasaiON is an Evidence-informed, Multimodal Self-regulation Program Designed to Reduce Emotional Distress and Strengthen Stress-regulation Skills by Combining Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Breathing Supported by Heart-rate Variability Biofeedback (HRV-B; emWave).
The goal of this clinical trial is to evaluate whether the LasaiON program, which combines transcutaneous auricular vagus nerve stimulation (taVNS) with breathing supported by heart rate variability biofeedback (HRV-B; emWave)…
- Trial name
- LasaiON (NCT07498881)
- Testing
- LasaiON
- Where
- Spain
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of the Basque Country (UPV/EHU)
Stroke
Tolerability of Transcutaneous Vagal Nerve Stimulation
The purpose of this study is to assess the feasibility and tolerability of transcutaneous auricular vagus nerve stimulation (taVNS) in childhood stroke survivors undergoing bi-manual occupational therapy.
- Trial name
- TAPSS-1 (NCT07735234)
- Testing
- transcutaneous auricular vagus nerve stimulation (taVNS)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- The University of Texas Health Science Center, Houston
Prader-Willi Syndrome
Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation
The present project project is divided in two parts. The primary aim of the part 1 of this study is to evaluate emotional control abilities of children with Prader-Willi syndrome (PWS) aged from 9 to 15 years and to study…
- Trial name
- PRACOM1 (NCT04526379)
- Testing
- Questionnaires, t-VNS
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Psychiatric Disorder
Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents
Non-suicidal self-injury (NSSI) are acts defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5) as intentional and deliberate, occurring outside a psychotic state and directly causing moderate injury.
- Trial name
- NEUROMUTE (NCT06433583)
- Testing
- transcutaneous auricular vagal nerve stimulation
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
Nephrotic Syndrome in Children, Minimal Change Disease
A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent…
- Conditions
- Nephrotic Syndrome in Children, Minimal Change Disease, Focal Segmental Glomerulosclerosis
- Trial name
- kidNEY-VNS (NCT05583942)
- Testing
- trascutaneous auricular vagus nerve stimulation
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Northwell Health
Crohn Disease, Ulcerative Colitis
Transcutaneous VNS to Treat Pediatric IBD
The current available therapies for inflammatory bowel disease (IBD), including immunomodulator and biologic medications may have toxicities limiting use or inadequate effect.
- Trial name
- STIMIBD (NCT03863704)
- Testing
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Northwell Health