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Feasibility Study for Intrathoracic Nerve Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066374
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Usman Ahmad, MD, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE August 20, 2019
First Posted Date  ICMJE August 26, 2019
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE August 13, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • 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.
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • Morphine equivalents taken [ Time Frame: up to 7 days ]
    Morphine equivalents taken during the inpatient period
  • Number of narcotics taken [ Time Frame: 7 days to 3 months ]
    Number of narcotics taken post discharge
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study for Intrathoracic Nerve Stimulation
Official Title  ICMJE Investigational Device Exemption for Intrathoracic Nerve Stimulation
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE Device: Peripheral Nerve Stimulation
Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
Other Name: Off-label use of Medtronic Intellis Spinal Cord Stimulation Device
Study Arms  ICMJE Experimental: Treatment Arm
Intrathoracic placement of neurostimulation device
Intervention: Device: Peripheral Nerve Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Usman Ahmad, M. D. 216-444-1921 ahmadu@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04066374
Other Study ID Numbers  ICMJE G190122
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Usman Ahmad, MD, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Usman Ahmad, M. D. The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP