Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery

NCT03994991 | Withdrawn FDA Device

• 1 other identifier: 201906717
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery; Chronic Pain; Transcranial Magnetic Stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (1)

• The presence of thoracic surgery related chronic pain at 6 months after surgery.

  6 months after thoracic surgery

Study Arms (2)

Active TMS

EXPERIMENTAL

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

Sham TMS

SHAM COMPARATOR

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

Interventions

active TMS DEVICE

Transcranial magnetic stimulation

Active TMS

sham TMS DEVICE

Sham transcranial magnetic stimulation

Sham TMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emine Bayman: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

• 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.

  PMID: 28248713 BACKGROUND

• 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.

  PMID: 29878248 BACKGROUND

• 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.

  PMID: 24968967 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emine O Bayman

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Jatin Vaidya, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: February 1, 2021
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)