rTMS for Orthopaedic Trauma Patients

Trial ID or NCT#

NCT03924024

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Repetitive Transcranial Magnetic Stimulation (rTMS) for Orthopaedic Trauma Patients

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Nolan Williams
Nolan Williams
Deep brain stimulation specialist, Neuroimaging specialist, Psychiatrist
Associate Professor of Psychiatry and Behavioral Sciences (Major Laboratories & Clinical Translational Neurosciences Incubator) and, by courtesy, of Radiology (Neuroimaging and Neurointervention)

Contact us to find out if this trial is right for you.

Contact

Romina Nejad, MSc
650-497-3933

View on ClinicalTrials.gov