rTMS for Orthopaedic Trauma Patients

Not Applicable

Withdrawn

• Conditions: Orthopaedic Trauma
• Interventions: Device: Accelerated intermittent theta burst treatment

• Registration Number: NCT03924024
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-23
• Study Start: 2019-08-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accelerated intermittent theta burst treatment	Accelerated intermittent theta burst treatment	All participants will receive accelerated intermittent theta-burst stimulation.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Hospital Anxiety and Depression Scale (HADS)	Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)	The Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. The depression items tend to focus on the anhedonic symptoms of depression. Items are rated on a 4-point severity scale (0 to 3). Overall scores range from 0 to 42, with lower scores corresponding to fewer symptoms. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states; each subscale score ranges from 0 to 21, with lower scores corresponding to fewer symptoms. Scores of greater than or equal to 11 on either HADS-A or HADS-D scales indicate a definitive case of anxiety and/or depression, respectively.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the Numeric Pain Rating Scale (NRS)	Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)	In a Numerical Rating Scale (NRS), patients are asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours.; The average of the 3 ratings is used to represent the patient's level of pain over the previous 24 hours.; Patients are asked to circle the number between 0 and 10 (first rating), 0 and 20 (second rating) and 0 and 100 (third rating) that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5)	Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)	The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It takes approximately 5-10 minutes to complete. It uses a 5-point Likert scale (0 = "Not at all" to 4 = "Extremely") to rate symptoms of PTSD. Scores can range from 0 to 60, with a cut-off score of 33 indicating a provisional diagnosis of PTSD until further psychometric work is available.; The PCL-5 has a variety of purposes, including: 1. Monitoring symptom change during and after treatment; 2. Screening individuals for PTSD; 3. Making a provisional PTSD diagnosis; When necessary, the PCL-5 can be scored to provide a provisional PTSD diagnosis.
Change from baseline in the Trauma Coping Self-Efficacy (CSE-T) scale	Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)	9 item self-report scale designed to assess participants' capability of dealing with events following exposure to a traumatic event. Participants are asked to rate their ability from 1 "I'm not at all capable" to 7 "I'm totally capable". The lower the score, the more likely the participant is struggling to cope with their trauma.

Trial Locations

Locations (1)

Department of Orthopaedic Surgery, Stanford Hospital; 🇺🇸 Palo Alto, California, United States