NeuromodulationReInvigorateNCT05998018
Randomized Study of the pdSTIM™ System in Failure to Wean Mechanically Ventilated Patients
A study testing pdSTIM System Therapy and Conventional Medical Management in people with Neuromodulation and Phrenic Nerve Stimulation, run by Stimdia Medical Inc. at 16 sites in United States.
Trial summary
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 stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromodulation, Phrenic Nerve Stimulation, Ventilator Induced Diaphragm Dysfunction
- What is being tested?
- pdSTIM System Therapy and Conventional Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 16 sitesUnited States
- Study dates
- 29 Sep 2023to 4 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years or older.
- Subject, or subject's Legally Authorized Representative, understands study requirements, study visits, and is willing and able to provide written informed consent prior to study specific procedures or testing.
- Subject has been on mechanical ventilation for ≥ 96 hours prior to randomization (intubation or tracheostomy).
- Subject has failed at least 1 weaning attempt (e.g., site directed spontaneous breathing trial(s) did not result in liberation).
- At the time of enrollment, the subject is likely to be ventilated for an additional 48 hours, at minimum, in the opinion of the investigator.
Who cannot join
- Subject has been on invasive mechanical ventilation for > 45 days.
- Subject failed to wean due to pre-existing neurological or neuromuscular issues affecting the respiratory muscles (e.g., ALS, phrenic nerve paralysis, inflammatory muscle disease, underlying myopathy, myasthenia gravis, cervical spinal injury).
- Subject's medical history, known anatomy or investigator's inability to visualize necessary anatomical landmarks that could prevent the safe placement of the pdSTIM leads.
- Subject is at risk of significant hemorrhage or is currently receiving a full dose of systemic anticoagulation (e.g., IV heparin, high dose of subcutaneous heparin. Subjects on prophylactic anticoagulation or daily aspirin regimen on their own are not excluded unless other exclusion criteria apply).
- Subject has an implant or external electrical device that may interact or interfere with the pdSTIM System (examples may include cardiac pacemaker, implantable defibrillator, vagal nerve stimulator, spinal cord stimulator, gastric stimulator, diaphragmatic stimulator).
- Subject has been diagnosed and has been treated for neck cancer within the past 5 years or subject had any prior radiation treatment to the neck.
Show all 16Show fewer
- Subject currently has hemodynamic instability due to any cause (e.g., severe sepsis, hemorrhagic shock, or septic shock) with vasopressor support > 0.1 mg/kg/min of norepinephrine or epinephrine, or equivalent, or is actively being titrated.
- Subject has a local infection at or around the proposed pdSTIM Lead insertion site.
- Subject is neutropenic or has signs of significant immunocompromise. (Subjects intubated for respiratory failure due to COVID-19 are not excluded unless other exclusion criteria apply).
- Subject has severe COPD as indicated by evidence of significant expiratory obstruction on the ventilator flow waveform or, where ventilator flow waveforms are not utilized, has a FEV1 ≤ 30%.
- Subject has pre-existing severe chronic pulmonary fibrosis.
- Subject has pleural effusion occupying greater than 1/3 of the pleural space on either side.
- Subject is currently on or expected to begin neuromuscular blockades.
- Subject is anticipating withdrawal of life support and/or shift to palliation as the goal of care with less than 6-months life expectancy.
- Subject is known or suspected to be pregnant or lactating.
- Subject is currently enrolled in or exited early from a) any investigational drug study or b) an investigational device study that may impact the ability to wean or is directly related to the lungs or diaphragm.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Northwell South Shore University Hospital
Bay Shore, New York, 11706
University at Buffalo
Buffalo, New York, 14203
Chandler Regional Medical Center
Chandler, Arizona, 85224
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Illinois Chicago
Chicago, Illinois, 60612
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
St. David's Healthcare
Georgetown, Texas, 78626
Abrazo West Campus
Goodyear, Arizona, 85395
RML Specialty Hospital
Hinsdale, Illinois, 60521
Houston Methodist
Houston, Texas, 77030
University of Louisville
Louisville, Kentucky, 40202
University of South Alabama
Mobile, Alabama, 36617
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
WakeMed Health
Raleigh, North Carolina, 27610
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
University of Michigan Health - West
Wyoming, Michigan, 49519
About this study
Official title: Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) 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 stimulation. Potential subjects who are on mechanical ventilation for at least four days and have failed at least one weaning attempt will be considered for the study. Those enrolled will be randomized in a 1:1 manner between the treatment group that is standard of care with the pdSTIM System and a Control group, which is standard of care alone.
Read the detailed description
The pdSTIM Pivotal Study (ReInvigorate Study) is a prospective, multicenter, randomized, controlled clinical study to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical ventilation for ≥ 96 hours (4 days) and have failed at least one weaning attempt will be considered for the study.
Those enrolled will be randomized in a 1:1 manner between a Treatment group that is standard of care with the pdSTIM System and a Control group that is standard of care only. For the Treatment group, stimulation therapy with pdSTIM will occur daily until the subject is successfully removed from mechanical ventilation or the 30-Day follow-up visit, whichever is sooner. All randomized subjects will be followed to 60 (± 7) days post randomization. Total subject participation will be no longer than 67 days.
- Conditions
- Neuromodulation, Phrenic Nerve Stimulation, Ventilator Induced Diaphragm Dysfunction, Mechanical Ventilation Weaning
- Being tested
- pdSTIM System Therapy, Conventional Medical Management
- Keywords
- Mechanical Ventilation, Phrenic Nerve Stimulation, Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pdSTIM System TherapyDevice
Stimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm
Conventional Medical ManagementOther
Conventional medical management
| Study group | Role | What they receive |
|---|---|---|
| pdSTIM System Therapy | Experimental | Not described Receives: Device: pdSTIM System Therapy; Other: Conventional Medical Management |
| Standard of Care | Active comparator | Not described Receives: Other: Conventional Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Wean
Assess time to successful weaning from mechanical ventilation for the subjects randomized to Treatment as compared to subjects randomized to Control
Measured: Following completion of the 30-day follow-up by all available randomized subjects
Secondary outcomes (1)
Mortality Rates
Compare 30-day mortality rates of Treatment and Control subjects
Measured: Following completion of the 30-day follow-up by all available randomized subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start29 Sep 2023
- Primary completion14 Apr 2025
- Study completion4 Sep 2025
Why it stopped: Stopped due to a business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuromodulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stimdia Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Conrad, MD,PhD, Principal investigator, LSU Health Sciences Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998018
- Sponsor's protocol ID
- CIP0002
- Acronym
- ReInvigorate
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2023
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schaaf K, Mullin CM, Cunningham KW, Eaton J, Conrad SA. The ReInvigorate Study-phrenic nerve-to-diaphragm stimulation for weaning from mechanical ventilation: a protocol for a randomized pivotal clinical trial. Trials. 2024 Aug 2;25(1):519. doi: 10.1186/s13063-024-08355-8.
PubMed 39095923
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT05998018
- Acronym / sponsor ID
- ReInvigorate / CIP0002
- Conditions
- Neuromodulation, Phrenic Nerve Stimulation, Ventilator Induced Diaphragm Dysfunction, Mechanical Ventilation Weaning
- Keywords
- Mechanical Ventilation, Phrenic Nerve Stimulation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to a business decision
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Stimdia Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Posted 13 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 stimulation. Potential subjects who are on mechanical ventilation for at least four days and have failed at least one weaning attempt will be considered for the study. Those enrolled will be randomized in a 1:1 manner between the treatment group that is standard of care with the pdSTIM System and a Control group, which is standard of care alone.
Detailed description
The pdSTIM Pivotal Study (ReInvigorate Study) is a prospective, multicenter, randomized, controlled clinical study to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical ventilation for ≥ 96 hours (4 days) and have failed at least one weaning attempt will be considered for the study.
Those enrolled will be randomized in a 1:1 manner between a Treatment group that is standard of care with the pdSTIM System and a Control group that is standard of care only. For the Treatment group, stimulation therapy with pdSTIM will occur daily until the subject is successfully removed from mechanical ventilation or the 30-Day follow-up visit, whichever is sooner. All randomized subjects will be followed to 60 (± 7) days post randomization. Total subject participation will be no longer than 67 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pdSTIM System Therapy | Experimental | Device: pdSTIM System Therapy, Other: Conventional Medical Management |
| Standard of Care | Active comparator | Other: Conventional Medical Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 18 years or older.
- Subject, or subject's Legally Authorized Representative, understands study requirements, study visits, and is willing and able to provide written informed consent prior to study specific procedures or testing.
- Subject has been on mechanical ventilation for ≥ 96 hours prior to randomization (intubation or tracheostomy).
- Subject has failed at least 1 weaning attempt (e.g., site directed spontaneous breathing trial(s) did not result in liberation).
- At the time of enrollment, the subject is likely to be ventilated for an additional 48 hours, at minimum, in the opinion of the investigator.
Key exclusion criteria (16 listed)
- Subject has been on invasive mechanical ventilation for > 45 days.
- Subject failed to wean due to pre-existing neurological or neuromuscular issues affecting the respiratory muscles (e.g., ALS, phrenic nerve paralysis, inflammatory muscle disease, underlying myopathy, myasthenia gravis, cervical spinal injury).
- Subject's medical history, known anatomy or investigator's inability to visualize necessary anatomical landmarks that could prevent the safe placement of the pdSTIM leads.
- Subject is at risk of significant hemorrhage or is currently receiving a full dose of systemic anticoagulation (e.g., IV heparin, high dose of subcutaneous heparin. Subjects on prophylactic anticoagulation or daily aspirin regimen on their own are not excluded unless other exclusion criteria apply).
- Subject has an implant or external electrical device that may interact or interfere with the pdSTIM System (examples may include cardiac pacemaker, implantable defibrillator, vagal nerve stimulator, spinal cord stimulator, gastric stimulator, diaphragmatic stimulator).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pdSTIM System TherapyStimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm | Device | pdSTIM System Therapy |
| Conventional Medical ManagementConventional medical management | Other | Standard of Care, pdSTIM System Therapy |
Primary outcome
Time to Wean
Time frame: Following completion of the 30-day follow-up by all available randomized subjects
Assess time to successful weaning from mechanical ventilation for the subjects randomized to Treatment as compared to subjects randomized to Control
1 secondary outcome
Mortality Rates
Time frame: Following completion of the 30-day follow-up by all available randomized subjects
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39095923Schaaf K, Mullin CM, Cunningham KW, Eaton J, Conrad SA. The ReInvigorate Study-phrenic nerve-to-diaphragm stimulation for weaning from mechanical ventilation: a protocol for a randomized pivotal clinical trial. Trials. 2024 Aug 2;25(1):519. doi: 10.1186/s13063-024-08355-8.
- Company WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Conrad, MD,PhD principal investigator
LSU Health Sciences Shreveport
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pdSTIM System Therapy and Conventional Medical Management in people with Neuromodulation and Phrenic Nerve Stimulation, run by Stimdia Medical Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Wean (time frame: Following completion of the 30-day follow-up by all available randomized subjects). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.