Clinical trials: Phrenic Nerve Stimulation
Inspiratory Strength Training (IST), Transcutaneous Spinal Stimulation
Rehab and Mechanical Ventilation
The goal of this research study is to evaluate the effects of a single session of rehabilitation in healthy adults, before noninvasive mechanical ventilation (MV). MV can help support breathing function during sleep or illness.
- Conditions
- Inspiratory Strength Training (IST), Transcutaneous Spinal Stimulation, Sham Spinal Stimulation
- Trial name
- REHAB-MV (NCT07427121)
- Testing
- Spinal cord stimulation, Inspiratory Strength Training
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Florida
Diaphragms, Phrenic Nerves
Electrical Phrenic Nerve Stimulation in Patients With VIDD
This study aims to examine efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) in ventilator-induced diaphragmatic dysfunction (VIDD).
- Trial name
- NCT06436950
- Testing
- transcutaneous electrical phrenic nerve stimulation (TEPNS)
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Peking University Third Hospital
Amyotrophic Lateral Sclerosis (ALS)
Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis
This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm…
- Trial name
- NCT01605006
- Testing
- NeuRx Diaphragm Pacing System (DPS)
- Where
- 11 sites in United States
- Volunteers
- 97 people
- Sponsor
- Synapse Biomedical
Sleep Apnea
Mapping for Acute Transvenous Phrenic Nerve Stimulation Study
The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.
- Trial name
- MAPs (NCT01981590)
- Testing
- Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.
- Where
- 2 sites in Netherlands, Sweden
- Volunteers
- 15 people
- Sponsor
- Medtronic BRC
Neuromodulation, Phrenic Nerve Stimulation
Randomized Study of the pdSTIM™ System in Failure to Wean Mechanically Ventilated Patients
This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve…
- Conditions
- Neuromodulation, Phrenic Nerve Stimulation, Ventilator Induced Diaphragm Dysfunction, Mechanical Ventilation Weaning
- Trial name
- ReInvigorate (NCT05998018)
- Testing
- pdSTIM System Therapy, Conventional Medical Management
- Where
- 16 sites in United States
- Volunteers
- 32 people
- Sponsor
- Stimdia Medical Inc.
Healthy
Quantification and Repeatability of Magnetic Stimulation
In this project the quantification and the repeatability of responses to rapid bilateral magnetic stimulation of the phrenic nerves will be investigated in healthy humans.
- Trial name
- NCT05302752
- Testing
- Magnetic phrenic nerve stimulation
- Where
- Switzerland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Swiss Federal Institute of Technology
Ventilator Lung, Ventilator-Induced Lung Injury
Phrenic Identification in the ICU
This will be a prospective observational study where the investigator will scan patients' necks with an ultrasound and look for anatomical landmarks that may help identify the phrenic nerve.
- Conditions
- Ventilator Lung, Ventilator-Induced Lung Injury, Diaphragm Disease, Phrenic Nerve
- Trial name
- NCT05875883
- Testing
- Neck ultrasound
- Where
- Canada
- Volunteers
- 63 people
- Sponsor
- Unity Health Toronto
Acute Hypoxemic Respiratory Failure, Diaphragm Injury
Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure
This is a single-center proof-of-concept clinical trial designed to establish the feasibility of transvenous phrenic-nerve stimulation (PNS) to maintain diaphragm activation over the first 24 hours and for up to seven days of…
- Conditions
- Acute Hypoxemic Respiratory Failure, Diaphragm Injury, Lung Injury
- Trial name
- STIMULUS (NCT05465083)
- Testing
- Lungpacer AeroPace Protect System
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University Health Network, Toronto
Lung, Organ Donation
Pacing In Organ Donors (the POD Trial)
The goal of this clinical trial is to test the feasibility of pacing the phrenic nerve to stimulate the diaphragm in order to improve the lung function in brain dead organ donors.
- Conditions
- Lung, Organ Donation, Mechanical Ventilation
- Trial name
- POD (NCT07505589)
- Testing
- Lungpacer AeroPace catheter and device
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- Fraser Health
Heart Failure
PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study
The PING-EP study is designed to evaluate electrode properties on phrenic nerve stimulation (PNS) in coronary sinus using a commercially available diagnostic electrophysiology catheter.
- Trial name
- PING-EP (NCT01109641)
- Testing
- diagnostic electrophysiology catheter
- Where
- 4 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Medtronic Italia
Phrenic Nerve, Electrical Stimulation
Repetitive Phrenic Nerve Stimulation in Critically Ill Patients Under Mechanical Ventilation
Subjects: Patients aged 19 and older who are currently in the ICU and undergoing invasive mechanical ventilation. Methods: The study involves performing non-invasive repetitive phrenic nerve stimulation in ICU patients on…
- Trial name
- NCT06491511
- Testing
- Transcutaneous, repetitive phrenic nerve electrical stimulation
- Where
- South Korea
- Volunteers
- 5 people
- Sponsor
- Seoul National University Hospital
Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle…
- Trial name
- PIRAT (NCT04844892)
- Testing
- Lungpacer PROTECT Diaphragm Pacing Therapy
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.
General Anaesthesia, Muscle Weakness
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities.
- Trial name
- STIMIT-I (NCT04946110)
- Testing
- Electromagnetic stimulation
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- Charite University, Berlin, Germany
Neuromuscular Diseases, Respiratory Failure
Establishment of a Non-invasive and Indirect Measure of Volitional Pimax
Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril and the maximal inspiratory pressure…
- Trial name
- PI MAX STIM (NCT02242162)
- Testing
- phrenic nerves magnetic stimulations
- Where
- France
- Volunteers
- 75 people
- Sponsor
- Centre d'Investigation Clinique et Technologique 805
Heart Failure
Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation
Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.
- Trial name
- ORPHEE (NCT03127202)
- Testing
- Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)
- Where
- 12 sites in France
- Volunteers
- 90 people
- Sponsor
- LivaNova
Muscle Weakness, Critical Illness
Electromagnetic Stimulation of the Phrenic Nerve in Critically Ill Mechanically Ventilated Patients (STIMIT-II)
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities.
- Conditions
- Muscle Weakness, Critical Illness, Mechanical Ventilation Complication
- Trial name
- STIMIT-II (NCT05238753)
- Testing
- Non-invasive electromagnetic stimulation
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Charite University, Berlin, Germany
Intensive Care Unit, Invasive Mechanical Ventilation
Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking
Development and validation of a new affordable and easy-to-use phrenic nerve stimulation tool for diaphragm strength assessment in intensive care unit
- Trial name
- SONOSTIM (NCT04199273)
- Testing
- Magnetic stimulation, Electric stimulation
- Where
- France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Montpellier
Critical Care, Intensive Care
Does Transcutaneous Phrenic Nerve Stimulation Prevent Diaphragm Atrophy?
Dear participant Participants's patient, who is participants's first-degree relative, who is connected to a ventilator in the intensive care unit, unconscious and not authorized to give informed consent, has been invited to…
- Trial name
- NMES (NCT06897774)
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Electrical Stimulation, Phrenic Nerve
Transcutaneous Repetitive Phrenic Nerve Stimulation in Healthy Adults
The goal of this observational study is to characterize the standardized stimulation parameter for noninvasive, transcutaneous, repetitive phrenic nerve electrical stimulation.
- Trial name
- NCT05879939
- Testing
- Transcutaneous, repetitive phrenic nerve electrical stimulation
- Where
- South Korea
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Healthy Subjects, Elective Surgical Procedure
"Electromagnetical Stimulation of Phrenic Nerve to Generate Contraction of the Diaphragm"
The scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized…
- Trial name
- NCT04884698
- Testing
- Stimit Activator
- Where
- Switzerland
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Stimit AG