A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Brainsway (HAC-Coil) deep Transcranial Magnetic Stimulation (DTMS) System for the Treatment of Post-Traumatic Stress Disorder (PTSD) Save

Date Added
June 27th, 2017
PRO Number
Pro00064375
Researcher
Mark George
Keywords
Depression, Military, Psychiatry, Stress Disorders
Summary

Objectives: The aim of the study is to evaluate the efficacy and safety of DTMS for the treatment of PTSD.
Patient Population: 176 male and female subjects, 22-68 years of age, currently diagnosed with PTSD according to the DSM-V criteria.
Structure: A randomized, controlled, prospective, 9 week, double blind, multicenter study.
Blinding: The treatment administrator, study rater, all study personnel and patients will be blinded to the treatment being administered.
Concurrent Control: The study group will receive active DTMS treatment and the control group will receive inactive, sham treatment.

Institution
MUSC
Recruitment Contact
Matthew Schmidt
843 577 5011 ext 5209
matthew.schmidt@va.gov

Optimization of ECT in the Treatment of Veterans with Co-morbid Major Depression and PTSD Save

Date Added
May 2nd, 2017
PRO Number
Pro00062581
Researcher
Mark George
Keywords
Depression, Military, Psychiatry
Summary

The purpose of this study is to determine if there are any differences in the improvement of MDD and PTSD symptoms when using two different types of ECT, and also to determine what effect recalling two different memories (a positive memory or negative PTSD memory) just prior to receiving ECT may have on PTSD symptoms. The two types of ECT treatment to be used in this study are called right unilateral ultrabrief (RUL UB) ECT and bilateral brief pulse (BL BP) ECT. Both types of ECT are widely used in the treatment of depression and are commonly used when ECT is recommended. This study will involve 70 (35 local and 35 at Long Beach VA site) subjects who are veterans suffering from MDD and PTSD.

Institution
MUSC
Recruitment Contact
Matthew Schmidt
843-577-5011 ext 5209
NA

Increasing Treatment Seeking Among At-Risk Service Members Returning From Warzones Save

Date Added
July 22nd, 2016
PRO Number
Pro00053847
Researcher
Tracy Stecker
Keywords
Depression, Military
Summary

We propose a randomized controlled clinical trial of 1,200 military service members who are at increased risk for suicide but not currently in behavioral health treatment. We are testing the effectiveness of a brief phone-based intervention aimed at changing military member's perceptions about behavioral health therapy. Participants will complete five interviews over the course of one year to collect information about change in behavioral health symptoms and treatment engagement.

Institution
MUSC
Recruitment Contact
Elizabeth BelBruno
603-646-7049
elizabeth.k.belbruno@dartmouth.edu

Adapting Web-Based ASAP (Alcohol and Sexual Assault Prevention) for Veterans Save

Date Added
June 7th, 2016
PRO Number
Pro00053156
Researcher
Amanda Gilmore
Keywords
Alcohol, Healthy Volunteer Studies, Mental Health, Military, Substance Use, Women's Health
Summary

The goal of this study is to receive Veteran feedback on an intervention being developed for female Veterans to reduce their risk of alcohol misuse and sexual assault. We are recruiting 20 female Veterans who engage in alcohol misuse to receive feedback on the intervention content. Feedback will be integrated into the intervention prior to being used with female Veterans.

Institution
MUSC
Recruitment Contact
Amanda Gilmore
843-792-8348
gilmoram@musc.edu

Glial Regulators for Testing Comorbid Posttraumatic Stress Disorder and Substance Use Disorders Save

Date Added
March 1st, 2016
PRO Number
Pro00052757
Researcher
Sudie Back
Keywords
Alcohol, Anxiety, Military, Stress Disorders, Substance Use
Summary

As a result of sustained operations in Afghanistan and Iraq, there are an increasing number of U.S. military Veterans with substance use disorders and comorbid posttraumatic stress disorder (PTSD). If left untreated, individuals with substance use disorders and PTSD are at increased risk for developing other mental health problems (e.g., depression, anxiety), suicidal ideation and attempts, medical problems, reduced resiliency and military readiness, vocational problems, and family/social impairment.Determine the benefits of N-acetylcysteine (NAC) in treating alcohol use disorder and comorbid post-traumatic stress disorder (PTSD) among military Veterans.

Institution
MUSC
Recruitment Contact
Jacelyn Lane
843-792-3788
lanejac@musc.edu

Ranger Resilience and Improved Performance on Phospholipid bound Omega-3?s (RRIPP-3 Study) Save

Date Added
January 26th, 2016
PRO Number
Pro00051532
Researcher
Bernadette Marriott
Keywords
Military, Nutrition
Summary

In this study, we will evaluate the impact of the dietary supplement of krill oil concentrate, which contains the omega-3 HUFAs, on the success of U.S. Army officers training outcomes in Infantry Basic Officer Leadership Course (IBOLC) training Part I) and Ranger training (Part II). We are researching the effects on key performance measures from the two parts of their training, as well as underlying psychological and cognitive functioning that are components of success. The questions addressed by this study are:

1. Will treatment with krill oil concentrate containing the omega-3 HUFAs improve cognitive and psychiatric functioning during U.S. Army Infantry Basic Officer Leadership Course (Part I)?

2. Will treatment with krill oil concentrate containing the omega-3 HUFAs improve the performance of officers during portions of the U.S. Army Infantry Basic Officer Leadership Course (Part I) and Ranger training (Part II)? This phase will combine the cognitive and physiological challenges from which we measure performance outcomes.

3. Do effects of the supplements continue once a person stops taking them? Are there any group differences in functioning observed 2 months after treatment is discontinued (i.e., after Ranger training)?

A small sub-study will address the same questions among older, more experienced Army personnel in Part I only.

Institution
MUSC
Recruitment Contact
Marcie Pregulman
792-2425
pregulma@musc.edu

The effects of impaired post-stroke coordination and motor pathway integrity on mobility performance Save

Date Added
November 6th, 2015
PRO Number
Pro00048394
Researcher
Steven Kautz
Keywords
Healthy Volunteer Studies, Military, Muscle, Physical Therapy, Rehabilitation Studies, Stroke Recovery
Summary

Walking is important to persons who have had a stroke and better rehabilitation methods are needed to restore or improve their walking. This project will investigate ways to improve upon and diagnose the specific underlying impairments. Future work will allow clinicians, such as physicians and physical therapists, to make measurements in their clinic to better diagnose a person?s specific walking deficit, design a specific treatment plan, and monitor its ability to restore or improve the person?s walking.

Institution
MUSC
Recruitment Contact
Christina Thompson
843-792-6313
thompchr@musc.edu

Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders Save

Date Added
June 2nd, 2015
PRO Number
Pro00042941
Researcher
Sudie Back
Keywords
Alcohol, Drug Studies, Mental Health, Military, Stress Disorders
Summary

The purpose of this study is to evaluate the effects of a medication (doxazosin) on reducing symptoms of posttraumatic stress disorder (PTSD) and substance use in Veterans. We will also examine the effects of doxazosin on brain activity at pre and post treatment.

Institution
MUSC
Recruitment Contact
Aisling Henschel
843-789-7193
henschel@musc.edu

VA Stroke Rehabilitation Research Database Save

Date Added
May 20th, 2015
PRO Number
Pro00043107
Researcher
Mark Bowden
Keywords
Military, Rehabilitation Studies, Stroke
Summary

The aim of this study is to gather information about veterans at the Ralph H. Johnson Veterans Medical Center (RHJ-VAMC) who've experienced a stroke and are interested in participating in rehabilitation research.

VA principal investigators at the Center for Rehabilitation Research in Neurologic Conditions (CRRNC) conduct stroke rehabilitation research for individuals. CRRNC include laboratories that investigate and assess upper extremity motor function, neuro-stimulation, communication and swallowing, locomotor energetics, locomotor and rehabilitation, and motor performance functions.

Participants will be asked to come to the CRRNC located at the Medical University of South Carolina (77 President Street, Charleston, South Carolina) and fill out a simple screening form with study personnel. Participants may be contacted in the future for qualifying studies.

Institution
MUSC
Recruitment Contact
Christina Thompson
843-792-6313
thompchr@musc.edu

Treatment of Prolonged Grief Disorder in Combat Veterans Save

Date Added
September 2nd, 2014
PRO Number
Pro00036533
Researcher
Ronald Acierno
Keywords
Anxiety, Depression, Mental Health, Military, Psychiatry
Summary

The 'dual burden' of (a) loss of a fellow service member in the context of (b) experiencing repeated extreme life threat is unique to military combat personnel and a core characteristic of combat-related Prolonged Grief Disorder (PGD), a disorder as prevalent as Post-traumatic stress disorder and associated with functional impairment, disability, and suicidality. Effective treatments for depression and PTSD have proven less than adequate in treating PGD when each is offered in isolation; and simply combining these 12-16 week treatment regimens into a 24-36 week treatments is not a viable approach, particularly with a population predisposed to avoiding extended mental health care. The proposed project addresses the need for a Veteran/ military specific treatment of PGD, and uses technology to deliver this treatment in a format that is far more likely to be accepted by military personnel and Veterans. This study will impact clinical practice by providing the first evidence for effective treatment PGD in Veterans.

Institution
MUSC
Recruitment Contact
Stephanie Zeigler
(843) 789-6519
zeigls@musc.edu

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