Clinical Trials
Our clinical trials address treatment gaps in traumatic brain injury (TBI)-related symptomatology, such as:
- Post-traumatic Stress (PTS)
- Depression
- Insomnia
- Headaches
Current treatments for these symptoms are only moderately effective, which threatens 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 and non-pharmacologic treatment approaches to a variety of symptoms across multiple timespans. Exerting the most rigorous standards, our trials are multicenter, randomized, double-blinded, and placebo controlled. Treatments include, but are not limited to:
- Pharmacologic
- Devices
- External stimulation devices (e.g. transcranial magnetic stimulation and light therapy)
- Digital therapeutics for the deployment of Cognitive Behavioral Therapy
- Behavioral Therapies
- Reconditioning therapies
- Cognitive Behavioral Therapy
Our trials also vary by 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 conducted at several large Military Treatment Facilities in the U.S.
- Remote Trials
- Conducted entirely by telephone, internet, or mail with 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 accommodate 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 Research Support teams. Below is an overview of our trial portfolio.
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 mild TBI, and 2). Determine the impact of eye movement on treatment response.
Location: Walter Reed National Military Medical Center
ClinicalTrials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT03796936?term=michael+roy&draw=2&rank=1
Study Flyer:
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
ClinicalTrials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT03649958?term=Neurotechnology+Following+Traumatic+Brain+Injury+%28Cereset%29&draw=2&rank=1
Reconsolidation of Traumatic Memories to Resolve Post-traumatic Stress
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
ClinicalTrials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT03827057?term=Michael+Roy&draw=2&rank=2
Improving Sleep Using Bright Light Therapy
Principal Investigators: Jessica Gill, PhD, RN, FAAN; Miranda Lim, MD, PhD
Aims: Tests the effect several at-home, easy to use devices have on sleep & cognition in veterans with or without a history of TBI.
Research Locations: Oregon Health and Sciences University and the VA Portland Health Care System; however, this study is also able to be conducted remotely
ClinicalTrials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT03578003?term=miranda+lim&draw=2&rank=3
Study Flyer: https://sharp.pvarf.com/join-a-study/
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 TBI, as an alternative to traditional in-person therapy.
Research Location: Uniformed Services University; however, this study is conducted remotely
ClinicalTrials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT04377009?term=David+Brody&draw=2&rank=4
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 TBI.
Research Location: Uniformed Services University; however this study will be conducted remotely
ClinicalTrials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT05147506?term=David+Brody&draw=2&rank=1
Study Flyer: N/A
Calcitonin gene-related peptide (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 TBI.
Research Locations: Proposed to be conducted at Naval Medical Center Camp Lejeune, Brooke Army Medical Center, Womack Army Medical Center, and William Beaumont Army Medical Center
ClinicalTrials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT05049057?term=David+Brody&draw=2&rank=6
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 service members with post-traumatic headache after mild TBI. 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