Feasibility Study for Intrathoracic Nerve Stimulation

June 14, 2024 updated by: The Cleveland Clinic

Investigational Device Exemption for Intrathoracic Nerve Stimulation

The purpose of this study is to conduct an early clinical evaluation of safety and feasibility of peripheral nerve stimulation (PNS) of the intercostal nerves using an electrical lead placed in the thoracic cavity as a safe and effective method of pain control after cardiothoracic surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Despite minimally invasive techniques in thoracic surgery, postoperative pain can still be an issue for patients. Achieving adequate pain control not only affects a patient's short and long term quality of life but is also extremely important in preventing post-operative complications. Pain hinders with ambulating earlier and in performing pulmonary toilet hence increasing the risk of ensuing complications. While surgeons use multimodal approaches (e.g., epidural, regional anesthesia, NSAIDs, and opioids) to treat the postoperative pain, patients may not find relief in the acute period. Additionally, the use of opioids in the postoperative period can lead to chronic dependence and misuse. According to the Center for Disease Control, nearly 25% of patients chronically dependent on opioids started taking narcotics after they underwent a surgical procedure. Every day more than 115 people a day die from narcotics, and costing the United States $78.5 billion dollars a year. To prevent the need for opioids and their associated side effects, we look beyond medications for postoperative pain control.

The field of neuromodulation has been studying the effects of magnetic field and electrical current stimulation of different areas of the body to treat pain. While this has been shown to be effective for complex regional pain syndrome, low back pain, migraines and post herpetic neuralgia, there have not been studies applying the same concept to patients in the acute postoperative period. The goal is to apply the same concept of peripheral nerve stimulation to treat post thoracic surgery pain and decrease the need for opioids for pain relief.

The purpose of this investigational device exemption is to study the efficacy of peripheral nerve stimulation in treating post thoracic surgery pain and the safety of using these stimulation leads in the thoracic cavity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sudish Murthy, MD PhD
  • Phone Number: 216 444-5640
  • Email: MURTHYS1@ccf.org

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Patients undergoing pulmonary surgery by open thoracotomy or thoracoscopy with or without robotic assistance.

Exclusion Criteria:

  • Woman who is pregnant,
  • Subjects who have an active systemic infection or are immunocompromised,
  • Subjects who will be exposed to diathermy or MRI,
  • Subjects who have an electrically active implant, e.g., cardiac pacemaker, defibrillator, or neurostimulator,
  • Subjects who are on anticoagulation therapy that would preclude their ability to undergo the implant procedure,
  • Subjects less than 22 years of age,
  • Subjects at elevated risk of infection or bleeding,
  • Subjects unable to consent on their own,
  • Subjects with active infection,
  • Subjects with immunocompromised state,
  • Subjects with preoperative chest pain,
  • Subjects with pleural space infection or inflammatory process,
  • Subjects undergoing esophageal, tracheal, or gastric procedures,
  • Subjects undergoing pneumonectomy,
  • Subjects with an uncorrectable coagulopathy,
  • Subjects who are allergic or have shown hypersensitivity to any materials of the neurostimulation system which come in contact with the body.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm
Intrathoracic placement of neurostimulation device
Device: Peripheral Nerve Stimulation
Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
Other Names:
  • Off-label use of Medtronic Intellis Spinal Cord Stimulation Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain as Measured by the Visual-analog Scale
Time Frame: Baseline to 3 months
Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome.
Baseline to 3 months
Freedom From Device Related Adverse Events
Time Frame: up to 7 days
Freedom from device related adverse events (i.e., bleeding, infection, pneumothorax or arrhythmias)
up to 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Morphine equivalents taken
Time Frame: up to 7 days
Morphine equivalents taken during the inpatient period
up to 7 days
Number of narcotics taken
Time Frame: 7 days to 3 months
Number of narcotics taken post discharge
7 days to 3 months
Pain control as measured by the McGill pain questionnaire
Time Frame: Screening, 7 days, 1 month and 3 month
Pain characteristics expressed by the study subject for the following criteria: Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot/Burning, Aching, Heavy, Tender, Splitting, Tiring/Exhausting, Sickening, Fearful, Punishing/Cruel, with the following scales: 0=None, 1=Mild, 2=Moderate, and 3=Severe. Lower scores represent the better outcome.
Screening, 7 days, 1 month and 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cleveland Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sudish Murthy, MD PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 9, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G190122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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