Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery

NCT ID: NCT03994991

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-05-19

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.

Conditions

Thoracic Surgery; Chronic Pain; Transcranial Magnetic Stimulation; Neuromodulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

active TMS

Intervention Type: DEVICE

Transcranial magnetic stimulation

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.

Group Type: SHAM_COMPARATOR

sham TMS

Intervention Type: DEVICE

Sham transcranial magnetic stimulation

Interventions

active TMS

Transcranial magnetic stimulation

Intervention Type: DEVICE

sham TMS

Sham transcranial magnetic stimulation

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emine Bayman

OTHER

Sponsor Role: lead

Responsible Party

Emine Bayman

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emine O Bayman

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Jatin Vaidya, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28248713 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29878248 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24968967 (View on PubMed)

Other Identifiers

201906717

Identifier Type: -

Identifier Source: org_study_id