Transcranial Magnetic Stimulation (TMS) for Thoracic Surgery

Emine Bayman

Status: Withdrawn

Conditions: Chronic Pain; Transcranial Magnetic Stimulation; Neuromodulation; Thoracic Surgery

Treatments: Device: sham TMS; Device: active TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03994991

201906717

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Active TMS

Experimental group

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.

Treatment:

Device: active TMS

Sham TMS

Sham Comparator group

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.

Treatment:

Device: sham TMS