Clinical Trials

Clinical Trials

Our clinical trials strategically address treatment gaps in traumatic brain injury (TBI)-related symptomatology, such as: 

  • Post-traumatic Stress Disorder
  • Depression
  • Insomnia
  • Headaches

Current treatment options for these symptoms are only moderately effective, which impacts the health, readiness, and competitive edge of our Nation’s Armed Forces. Our trials expand upon our previous research to narrow knowledge gaps and improve TBI treatment guidelines.

Our clinical trials apply novel pharmacologic (drug) and non-pharmacologic treatment approaches to a variety of symptoms across multiple timespans (e.g., acute, sub-acute, and chronic). Exerting the most rigorous standards, our trials are multicenter, randomized, double-blinded, and placebo controlled. Study treatments include, but are not limited to:

Our trials vary by treatment and design. This diverse repertoire ensures each trial is customized for distinct populations and environments. Our trial designs include:

  • On-site trials
    • Ongoing or upcoming research within the Washington D.C. area 
    • Multi-center studies deployed throughout several large Military Treatment Facilities in the U.S. 
  • Remote Trials
    • Conducted entirely by telephone, internet, or mail
    • Online consent capabilities
    • Direct data entry with patient completed collection through the use of internet accessed surveys and questionnaires
  • A hybrid in-person study design model that can accomodate partial to full remote activities

Clinical trials require a multifaceted and integrated approach. Our trials are supported by our in-house Clinical Trials Unit, Clinical Core Facilities, and Program Management team. An overview of our trial portfolio is depicted and described below. 

CNRM Clinical Trials Pipeline

Trial Overviews

3MDR to Treat Post-Traumatic Stress and Mild TBI
Principal Investigator: Michael Roy, MD, MPH, COL (Ret)
Aims: 1). Obtain an initial estimate of the efficacy of 3MDR in service members with comorbid PTS and mTBI, and 2). Determine the impact of eye movement on treatment response.
Location: Walter Reed National Military Medical Center
 
Closed-loop Allostatic Neurotechnology for Sensory Function and Pain Management After Mild TBI
Principal Investigator: Michael Roy, MD, MPH, COL (Ret)
Aim: To evaluate the efficacy of a noninvasive, closed-loop, acoustic stimulation neurotechnology, during which musical tones are echoed, or mirrored back in real time, to reflect one's own brain activity.
Research Location: Uniformed Services University and Womack Army Medical Center
 
Reconsolidation of Traumatic Memories to Resolve Post-traumatic Stress Disorder
Principal Investigator: Michael Roy, MD, MPH, COL (Ret)
Aim: To evaluate the effectiveness of Reconsolidation of Traumatic Memories in reducing post-traumatic stress symptom severity in active duty or retired service members.
Location: Walter Reed National Military Medical Center; however, this study is also able to be conducted remotely
 
Improving Sleep Using Bright Light Therapy
Principal Investigators: Jessica Gill, PhD, RN, FAAN; Miranda Lim, MD, PhD 
Aims: 1). Explore the efficacy of morning bright light therapy (MBLT) in veterans with TBI-related sleep disturbances, 2). Determine if MBLT effects cognition, and 3). Identify specific biomarkers indicative of TBI-related sleep disturbances.
Research Locations: Oregon Health and Sciences University and the VA Portland Health Care System; however, this study is also able to be conducted remotely
 
Internet-guided Cognitive Behavioral Therapy for TBI-related Insomnia
Principal Investigators: David Brody, MD, PhD; John “Kent” Werner, PhD, MD
Aim: To validate an internet-guided cognitive behavioral therapy mobile application in service members and veterans with insomnia and a history of traumatic brain injury, as an alternative to traditional in-person therapy.
Research Location: Uniformed Services University; however, this study is conducted remotely
 
Adaptive Transcranial Magnetic Stimulation for Depression
Principal Investigator: David Brody, MD, PhD
Aim: Investigate the efficacy and tolerability of repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in U.S. service members and veterans with mild TBI.
Research Locations: Walter Reed National Military Medical Center; Fort Belvoir Community Hospital; Brooke Army Medical Center; and exploring three other large military treatment facilities throughout the U.S.
ClinicalTrials.Gov Link: N/A
Study Flyer: N/A
 
Mobile Application to Counteract Depression and Concussion
Principal Investigator: David Brody, MD, PhD
Aim: Develop and test a new smartphone application for service members and veterans with symptoms of depression and a history of mild traumatic brain injury.
Research Location: Uniformed Services University; however this study will be conducted remotely
ClinicalTrials.Gov Link: N/A
Study Flyer: N/A
 
CGRP Antagonist for Acute Post-Traumatic Headache
Principal Investigator: David Brody, MD, PhD; Ann Scher, PhD; Alan Finkle, MD 
Aim: A randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab (Aimovig®) 140 mg for the preventive treatment of post-traumatic headache in service members with mild traumatic brain injury
Research Locations: Proposed to be conducted at Camp Lejeune, Brooke Army Medical Center, Womack Army Medical Center, and additional military treatment facilities
ClinicalTrials.Gov Link: N/A
Study Flyer: N/A
 
Mobile Application for Managing Post-Traumatic Headaches after Concussion
Principal Investigator: David Brody, MD, PhD
Aim: Develop a novel digital therapeutic mobile app utilizing cognitive behavioral therapy for post-traumatic headache after concussion. Conduct a pilot randomized controlled trial to assess feasibility, user acceptability, and preliminary efficacy of the digital therapeutic mobile app.
Research Location: Uniformed Services University; however, this study will be conducted remotely
ClinicalTrials.Gov Link: N/A
Study Flyer: N/A