rTMS for Orthopaedic Trauma Patients

May 3, 2022 updated by: Nolan R, Stanford University

Repetitive Transcranial Magnetic Stimulation (rTMS) for Orthopaedic Trauma Patients

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Department of Orthopaedic Surgery, Stanford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Accelerated intermittent theta burst treatment
All participants will receive accelerated intermittent theta-burst stimulation.
Device: Accelerated intermittent theta burst treatment

All participants will receive accelerated intermittent theta-burst stimulation to the left DLPFC. Stimulation intensity will be standardized to 80% of resting motor threshold.

Stimulation will be delivered to L-DLPFC using the Brainsway stimulator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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.
Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Numeric Pain Rating Scale (NRS)
Time Frame: 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'.
Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)
Change from baseline in the PTSD Checklist for DSM-5 (PCL-5)
Time Frame: 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.
Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)
Change from baseline in the Trauma Coping Self-Efficacy (CSE-T) scale
Time Frame: 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.
Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Orthopaedic Trauma

Clinical Trials on Accelerated intermittent theta burst treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe