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出境医 / 临床实验 / Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery

Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery

Study Description
Brief Summary:
Patients with high severity of post-surgical pain scores will be randomized to transcranial magnetic stimulation (TMS) vs sham TMS groups. Both group of patients will have 10 TMS sessions during 5 days. Our hypothesis is that, the reduction in the severity of pain scores will be greater among those patients who are randomized to active TMS group compared to sham TMS group. The investigators will explore how improvements in pain correlate with changes in brain network connectivity.

Condition or disease Intervention/treatment Phase
Thoracic Surgery Chronic Pain Transcranial Magnetic Stimulation Neuromodulation Device: active TMS Device: sham TMS Not Applicable

Detailed Description:

More than 25 million adults suffer from chronic pain in the United States making it the single most common symptom for which patients seek medical care. Although chronic pain can develop from a variety conditions, surgery is one of the most common and the incidence of chronic pain after thoracic surgery is particularly high. Opioids have been a mainstay therapy for post-surgical pain, but there is increasing awareness that post-surgical opioid use is a risk factor for addiction. Consequently, there are major nationwide efforts underway to limit opioid use in the post-surgical setting and identify safer options. One promising modality that has emerged in recent years is the use of non-invasive brain stimulation using transcranial magnetic stimulation (TMS).

TMS provides a method for noninvasively modulating cortical excitability, and a number of studies have shown that non-invasive neuromodulation can reduce pain in patients suffering from chronic pain. Using resting state functional magnetic resonance imaging, the investigators propose to investigate changes in brain networks after TMS and additionally investigate individual differences in brain network connectivity patterns that predict the effectiveness of TMS. The investigators expect that active TMS, compared to sham TMS, will normalize brain network connectivity and lead to lower pain and opioid use after surgery. In addition, by assessing pre-surgical brain networks, the investigators hope to identify brain connectivity patterns that predict efficacy of TMS as a post-surgical treatment option.

The investigators will recruit 36 subjects who've undergone thoracic surgery. The investigators will recruit primarily in-patients but may also recruit patients who have gone home after surgery.

During weeks 2-3 Post-Surgery, 5 study visits will be completed, each ranging in duration from 1 1/2 - 3 hours. All 5 visits include 2 short TMS sessions (10 total), pain and mood assessments. At V1 and V5, functional magnetic resonance imaging (fMRI) scans will be completed, as well as additional pain and health related assessments (many only done at V1). Also, short, follow-up phone calls will be completed at 3 and 6 months post-surgery to assess pain and other outcomes.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Patients will be randomized to active TMS vs sham TMS groups with approximately a 2:1 ratio. At the end of the study, the investigators expect 24 patients to have active TMS and 12 patients to have sham TMS sessions.

Patients in the sham TMS group will have appointments at the same time as the active TMS patients. The TMS device used for the sham TMS group patients will be identical to the active TMS group. Only the stimulation will be different.
Primary Purpose: Treatment
Official Title: Personalized Neuromodulation for Treating Post-surgical Pain
Estimated Study Start Date : February 1, 2021
Actual Primary Completion Date : May 19, 2021
Actual Study Completion Date : May 19, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Active TMS
Patients in the active TMS group will receive active TMS 2 times a day for 5 days. In addition, these patients will have MRI before the first TMS session and after the last TMS session.
 Device: active TMS
Transcranial magnetic stimulation
Sham Comparator: Sham TMS
Patients in the shamTMS group will receive sham TMS 2 times a day for 5 days. In addition, these patients will have MRI before the first TMS session and after the last TMS session.
 Device: sham TMS
Sham transcranial magnetic stimulation
Outcome Measures
Primary Outcome Measures :
  1. The change in the severity of pain score after 5 days of active vs sham TMS. [ Time Frame: 5 days ]

    The change in pain score will be calculated based on the following 2 pain scores:

    Day 1 NRS is the severity of pain collected at the beginning of the first study visit before the TMS and MRI sessions.

    Day 5 NRS is the severity of pain collected at the end of the 5th study visit, after the second TMS and the MRI session.

    The change in pain score is the difference between the day 5 NRS and the day 1 NRS.



Secondary Outcome Measures :
  1. The presence of thoracic surgery related chronic pain at 6 months after surgery. [ Time Frame: 6 months after thoracic surgery ]
    Pain assessments at 6 months aftger surgery will be made with phone interview. Patients will be asked if they still have pain related to their thoracic surgery ('Do you currently have pain related to your thoracic surgery? [yes/ no]')


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking
  • 18 to 80 years old
  • scheduled thoracic surgery w/one of the following procedures: thoracotomy, pneumonectomy, removal of lung other than bilobectomy, pneumonectomy, completion pneumonectomy, sleeve lobectomy, segmentectomy, single or multiple wedge resection, or thoracoscopy with excision-plication of bullae, with lobectomy, with partial or total pulmonary decortication or with wedge resection of lung.
  • Post-surgery pain equal or greater 4 at phone screen

Exclusion Criteria:

  • limitations of self-expression or visual dysfunction (as assessed by research team member during inpatient screen)
  • having emergency surgery
  • bipolar, schizophrenia or other psychotic disorders
  • Alzheimer's, dementia, epilepsy, traumatic brain injury or other similarly impacting neurological issues
  • pregnancy
  • incarceration
  • pain in thoracic region for last two or more months
  • additional MRI/TMS exclusions: (implants, stents, neurostimulators, metal, claustrophobia, certain medications)
Contacts and Locations

Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Emine Bayman
Investigators
Layout table for investigator information
Principal Investigator: Emine O Bayman University of Iowa
Principal Investigator: Jatin Vaidya, PhD University of Iowa
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date May 24, 2021
Estimated Study Start Date  ICMJE February 1, 2021
Actual Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		The change in the severity of pain score after 5 days of active vs sham TMS. [ Time Frame: 5 days ]
The change in pain score will be calculated based on the following 2 pain scores: Day 1 NRS is the severity of pain collected at the beginning of the first study visit before the TMS and MRI sessions. Day 5 NRS is the severity of pain collected at the end of the 5th study visit, after the second TMS and the MRI session. The change in pain score is the difference between the day 5 NRS and the day 1 NRS.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		The presence of thoracic surgery related chronic pain at 6 months after surgery. [ Time Frame: 6 months after thoracic surgery ]
Pain assessments at 6 months aftger surgery will be made with phone interview. Patients will be asked if they still have pain related to their thoracic surgery ('Do you currently have pain related to your thoracic surgery? [yes/ no]')
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 Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery
Official Title  ICMJE Personalized Neuromodulation for Treating Post-surgical Pain
Brief Summary Patients with high severity of post-surgical pain scores will be randomized to transcranial magnetic stimulation (TMS) vs sham TMS groups. Both group of patients will have 10 TMS sessions during 5 days. Our hypothesis is that, the reduction in the severity of pain scores will be greater among those patients who are randomized to active TMS group compared to sham TMS group. The investigators will explore how improvements in pain correlate with changes in brain network connectivity.
Detailed Description

More than 25 million adults suffer from chronic pain in the United States making it the single most common symptom for which patients seek medical care. Although chronic pain can develop from a variety conditions, surgery is one of the most common and the incidence of chronic pain after thoracic surgery is particularly high. Opioids have been a mainstay therapy for post-surgical pain, but there is increasing awareness that post-surgical opioid use is a risk factor for addiction. Consequently, there are major nationwide efforts underway to limit opioid use in the post-surgical setting and identify safer options. One promising modality that has emerged in recent years is the use of non-invasive brain stimulation using transcranial magnetic stimulation (TMS).

TMS provides a method for noninvasively modulating cortical excitability, and a number of studies have shown that non-invasive neuromodulation can reduce pain in patients suffering from chronic pain. Using resting state functional magnetic resonance imaging, the investigators propose to investigate changes in brain networks after TMS and additionally investigate individual differences in brain network connectivity patterns that predict the effectiveness of TMS. The investigators expect that active TMS, compared to sham TMS, will normalize brain network connectivity and lead to lower pain and opioid use after surgery. In addition, by assessing pre-surgical brain networks, the investigators hope to identify brain connectivity patterns that predict efficacy of TMS as a post-surgical treatment option.

The investigators will recruit 36 subjects who've undergone thoracic surgery. The investigators will recruit primarily in-patients but may also recruit patients who have gone home after surgery.

During weeks 2-3 Post-Surgery, 5 study visits will be completed, each ranging in duration from 1 1/2 - 3 hours. All 5 visits include 2 short TMS sessions (10 total), pain and mood assessments. At V1 and V5, functional magnetic resonance imaging (fMRI) scans will be completed, as well as additional pain and health related assessments (many only done at V1). Also, short, follow-up phone calls will be completed at 3 and 6 months post-surgery to assess pain and other outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Patients will be randomized to active TMS vs sham TMS groups with approximately a 2:1 ratio. At the end of the study, the investigators expect 24 patients to have active TMS and 12 patients to have sham TMS sessions.

Patients in the sham TMS group will have appointments at the same time as the active TMS patients. The TMS device used for the sham TMS group patients will be identical to the active TMS group. Only the stimulation will be different.

Primary Purpose: Treatment
Condition  ICMJE
  • Thoracic Surgery
  • Chronic Pain
  • Transcranial Magnetic Stimulation
  • Neuromodulation
Intervention  ICMJE
  • Device: active TMS
    Transcranial magnetic stimulation
  • Device: sham TMS
    Sham transcranial magnetic stimulation
Study Arms  ICMJE
  • Experimental: Active TMS
    Patients in the active TMS group will receive active TMS 2 times a day for 5 days. In addition, these patients will have MRI before the first TMS session and after the last TMS session.
    Intervention: Device: active TMS
  • Sham Comparator: Sham TMS
    Patients in the shamTMS group will receive sham TMS 2 times a day for 5 days. In addition, these patients will have MRI before the first TMS session and after the last TMS session.
    Intervention: Device: sham TMS
Publications *
  • Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576.
  • Bayman EO, Parekh KR, Keech J, Larson N, Vander Weg M, Brennan TJ. Preoperative Patient Expectations of Postoperative Pain Are Associated with Moderate to Severe Acute Pain After VATS. Pain Med. 2019 Mar 1;20(3):543-554. doi: 10.1093/pm/pny096.
  • Bayman EO, Brennan TJ. Incidence and severity of chronic pain at 3 and 6 months after thoracotomy: meta-analysis. J Pain. 2014 Sep;15(9):887-97. doi: 10.1016/j.jpain.2014.06.005. Epub 2014 Jun 23. Review.

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 19, 2021) 		0
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		36
Actual Study Completion Date  ICMJE May 19, 2021
Actual Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English speaking
  • 18 to 80 years old
  • scheduled thoracic surgery w/one of the following procedures: thoracotomy, pneumonectomy, removal of lung other than bilobectomy, pneumonectomy, completion pneumonectomy, sleeve lobectomy, segmentectomy, single or multiple wedge resection, or thoracoscopy with excision-plication of bullae, with lobectomy, with partial or total pulmonary decortication or with wedge resection of lung.
  • Post-surgery pain equal or greater 4 at phone screen

Exclusion Criteria:

  • limitations of self-expression or visual dysfunction (as assessed by research team member during inpatient screen)
  • having emergency surgery
  • bipolar, schizophrenia or other psychotic disorders
  • Alzheimer's, dementia, epilepsy, traumatic brain injury or other similarly impacting neurological issues
  • pregnancy
  • incarceration
  • pain in thoracic region for last two or more months
  • additional MRI/TMS exclusions: (implants, stents, neurostimulators, metal, claustrophobia, certain medications)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994991
Other Study ID Numbers  ICMJE 201906717
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emine Bayman, University of Iowa
Study Sponsor  ICMJE Emine Bayman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emine O Bayman University of Iowa
Principal Investigator: Jatin Vaidya, PhD University of Iowa
PRS Account University of Iowa
Verification Date May 2021

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

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