rTMS for Orthopaedic Trauma Patients

Stanford University

Status: Withdrawn

Conditions: Orthopaedic Trauma

Treatments: Device: Accelerated intermittent theta burst treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03924024

49006

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Accelerated intermittent theta burst treatment

Experimental group

Description:

All participants will receive accelerated intermittent theta-burst stimulation.

Treatment:

Device: Accelerated intermittent theta burst treatment