Clinical trial NCT03924024: rTMS for Orthopaedic Trauma Patients
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for Orthopaedic Trauma Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Orthopaedic Trauma
Keywords: Depression
Transcranial Magnetic Stimulation (TMS)
Theta Burst
Orthopaedic Trauma
Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for orthopaedic trauma patients. In this open label study, all participants will receive accelerated theta-burst stimulation. This study will examine whether symptoms of psychiatric distress and opioid use in orthopaedic trauma patients can be mitigated with rTMS to improve post-injury recovery.

Detailed description: A large percentage of orthopaedic trauma patients suffer from psychiatric distress and chronic pain related to their injury and underlying psychosocial factors; this predicts poor post-injury recovery.

Repetitive transcranial magnetic stimulation (rTMS) is a neuromodulation technique used to stimulate areas of the brain that may modulate symptoms of pain, depression, and post-traumatic stress. The FDA-approved rTMS protocol for treatment is 10Hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (L-DLPFC) for the treatment of depression. This methodology has been very successful in real world situations, however poses some limitations, including the duration of the treatment session (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study will use modified parameters to create a more rapid form of treatment and look at outcome changes in pain and depression, commonly seen in orthopaedic trauma patients.

Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 65 years of age.
* Able to provide informed consent.
* Present to Stanford Emergency Department as a trauma with a major operative lower extremity injury
* Glasgow coma scale of 15 within 24 hours after admission or extubation
* Negative urinary toxicology screen for illicit substances;
* Negative pregnancy test if female and less then 60 y/o;
* No suspicion for a head injury and/or negative head CT scan for intracranial hemorrhage or injury based on standard of care
* No history of seizure disorder or other neurological disorders.
* All patients included must screen positive for PHQ-9 score \>4 (positive symptoms of depression) and CES-T score \<36 (poor coping self-efficacy).

Exclusion Criteria:

* Incarceration,
* Pregnant females,
* Prior psychotic disorder,
* Current use of anti-depressant or anti-psychotic medications,
* Prior-admission opioid use within 30 days (patients will be screened for recent prescription opioid use using the CURES report),
* Heavy alcohol use,
* Lesional neurological disorder or brain implant or intracranial ferromagnetic material,
* Seizure disorder

Primary outcomes:
measure: Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)
Secondary outcomes:
measure: Change from baseline in the Numeric Pain Rating Scale (NRS)
timeFrame: Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)
measure: Change from baseline in the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)
measure: Change from baseline in the Trauma Coping Self-Efficacy (CSE-T) scale
timeFrame: Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Department of Orthopaedic Surgery, Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Nolan Williams, MD
role: PRINCIPAL_INVESTIGATOR
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