search
Back to results

Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery

Primary Purpose

Thoracic Surgery, Chronic Pain, Transcranial Magnetic Stimulation

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active TMS
sham TMS
Sponsored by
Emine Bayman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active TMS

Sham TMS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The change in the severity of pain score after 5 days of active vs sham TMS.
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

The presence of thoracic surgery related chronic pain at 6 months after 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]')

Full Information

First Posted
June 19, 2019
Last Updated
May 19, 2021
Sponsor
Emine Bayman
search

1. Study Identification

Unique Protocol Identification Number
NCT03994991
Brief Title
Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery
Official Title
Personalized Neuromodulation for Treating Post-surgical Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
We weren't able to enroll patients due to COVID19 pandemic.
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emine Bayman

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery, Chronic Pain, Transcranial Magnetic Stimulation, Neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active TMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham TMS
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
active TMS
Intervention Description
Transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
sham TMS
Intervention Description
Sham transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
The change in the severity of pain score after 5 days of active vs sham TMS.
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
The presence of thoracic surgery related chronic pain at 6 months after surgery.
Description
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]')
Time Frame
6 months after thoracic surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine O Bayman
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jatin Vaidya, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28248713
Citation
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.
Results Reference
background
PubMed Identifier
29878248
Citation
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.
Results Reference
background
PubMed Identifier
24968967
Citation
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.
Results Reference
background

Learn more about this trial

Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery

We'll reach out to this number within 24 hrs