Patient Clinical Studies
Nova Southeastern University's Dr. Kiran C. Patel College of Osteopathic Medicine stands at the forefront of cutting-edge research and transformative discoveries. NSU and the College of Osteopathic Medicine play a pivotal role in conducting patient clinical studies that are vital for the progress of medicine. These studies provide valuable insights into the effectiveness of innovative therapies and interventions and allow patients to access potential breakthrough treatments before they become widely available.
Through rigorous scientific investigations and ethical practices, NSU and the College of Osteopathic Medicine exemplify the importance of patient clinical trials in shaping the future of health care; fostering collaboration between researchers, health care professionals, and patients; and ultimately, paving the way for a healthier and more prosperous society.
Post Traumatic Stress Disorder
The Effects of a Psychoeducational Intervention on Health and Performance-based Outcomes of Veterans Diagnosed With PTSD
Nova Southeastern University and the Veterans trust through this line of research will strengthen community engagement and awareness for the need to recognize and provide treatment models for veterans diagnosed with PTSD. The goal is to improve self-regulatory mechanisms within the racecar simulated-environment with the hope it translates to real-life scenarios.
The design is a single-case approach with the application of range-bound changing criterion design. It will include elements of stress-inoculation therapy, cognitive processing therapy, optimal zones of functioning, biofeedback, and psychological skills training. This particular design will allow for the collection and identification of the idiosyncratic differences between each participant which will guide how the data are collected and the tailoring of the intervention.
Contact:
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The Effectiveness of Guided Imagery on PCL-5 Scores in Adult Women with Post-Traumatic Stress Disorder (PTSD)
Post-Traumatic Stress Disorder (PTSD) affects a significant portion of the population, with about 13 million Americans diagnosed in 2020. Women are twice as likely to have PTSD than men. PTSD will affect 8%, or 8 out of every 100 women, at some stage in their lives. This study will check the effects of guided imagery mindfulness on PCL-5 scores in adult women with PTSD. Participants in this study will complete a PCL-5 pre-test and post-test to check PTSD symptoms before and after 6 weeks of mindfulness sessions. Each participant will engage in 15-minute sessions of guided imagery mindfulness once a week for 6 weeks. Before and after PCL-5 scores will show the effect of guided imagery mindfulness on PTSD symptom severity.
Contact:
Kellie-Ann J Kerr, BSN, RN
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Gulf War Illness
Study of Bacopa in Gulf War Illness Patients
Gulf War Illness is a condition that affects multiple major organ systems, resulting in a diverse array of symptoms that include debilitating fatigue, memory and cognition difficulties, headaches, sleep disturbances, gastrointestinal problems, skin rashes, and musculoskeletal/joint pain. This phase II, double masked, randomized, placebo-controlled, two-arm study will evaluate cognitive function as evidence of efficacy of the nutraceutical intervention, Bacopa, on central nervous system symptom management of Gulf War Illness, along with assessments of safety of the intervention.
Contact:
Mayra Vidro, MPH
For more information, visit the link below:
Study Details | Study of Bacopa in Gulf War Illness Patients | ClinicalTrials.gov
GWICTIC: NAC Mechanistic Study in Gulf War Veterans (NAC)
This mechanistic study will test if NAC affects chronic oxidative stress and depletion of antioxidants in GWI participants. Blood specimen collection and neuroimaging will be used to determine whether NAC affects serum glutathione (GSH) concentration and oxidative stress in the CNS when compared to placebo.
Contact:
Nancy Klimas, M.D.
For more information, visit the link below:
Study Details | GWICTIC: NAC Mechanistic Study in Gulf War Veterans (NAC) | ClinicalTrials.gov
Efficacy of a Breathwork Practice (SKY) on Well-Being of Individuals With Parkinson's Disease (iPD) and Care Partners (SKYforiPD)
The goal of this feasibility study and clinical trial is to learn if an evidenced-based breathwork and meditation intervention (SKY Breath) will improve the mental and physical well-being of individuals with Parkinson's Disease (iPD) in stages 1, 2, and 3, under the age of 75 and their care partners. The main questions it aims to answer are:
- Objective 1: Can the SKY Breath practice be designed and implemented to specifically cater to the unique needs of individuals with Parkinson's Disease and their care partners.
- Objective 2: Will the SKY Breath practice decrease stress levels (a contributor to increasing PD symptoms) for individuals with Parkinson's Disease (iPD) and their care partners as measured through self-reported surveys to improve overall well-being and quality of life.
- Objective 3: Will the SKY Breath practice in part alleviate the emotional stress and physical burden experienced by care partners of PD patients, promoting their resilience and well-being.
Participants will be asked to learn the SKY Breath and Meditation practice over the course of 4 days (2.25 hours each morning), practice SKY every day for 4 weeks and keep a log of time spent doing SKY. The participants will complete a series of surveys before learning the practice and then after at weeks 1, 4 and 8. The series of surveys will take about 20 minutes.
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Nicotinamide Riboside Clinical Trial for GWI
The 1991 Gulf War (GW) was fought by a coalition of 30 countries that included 700,000 U.S. troops. Although the war itself lasted two months, adverse health consequences from this conflict are still experienced by GW veterans. Soon after their return, many soldiers started reporting multiple, seemingly unrelated symptoms, such as memory impairment, fatigue, gastrointestinal problems, and widespread pain. This illness, termed Gulf War Illness (GWI), affects about 32% of GW veterans. Several preclinical studies suggest the presence of bioenergetic deficits in the blood and brains of veterans with GWI, as well as in the mouse models of this illness. The investigators' recent work shows that plasma levels of bioenergetic metabolites, such as nicotinamide adenine dinucleotide (NAD+), are lower in veterans with GWI compared to healthy GW controls. This corresponds with low Sirt1 levels in the peripheral blood mononuclear cells (PBMC) from veterans with GWI. Given the importance of NAD+ in cellular bioenergetics, various approaches have been explored for supplementing NAD+. Among these, supplementation with the NAD+ precursor nicotinamide riboside (NR) appears to be a viable option, since this form of NAD+ can enter the cell and cross the blood-brain-barrier. The investigators' recent animal studies show that supplementation with NR, a member of the vitamin B3 family, can correct the bioenergetic deficits in GWI mice, which corresponds with an improvement in fatigue-type behavior that is commonly reported by veterans with GWI. The main objective of this project is to determine, through the use of metabolomics and biochemical assays, if NR supplementation can maintain a healthy bioenergetic profile in the blood of veterans with GWI. The secondary objective is to determine if NR can maintain healthy blood lipid and immune biomarker profiles in GWI veterans. The study will also explore whether NR can improve general health and well-being of veterans with GWI.
Contact:
Dakota Helgager
For more information, visit the link below:
Study Details | Nicotinamide Riboside Clinical Trial for GWI | ClinicalTrials.gov
Confirmation of Diet as a Treatment for Gulf War Illness
This clinical trial aims to confirm previous findings from a smaller study which demonstrated significant improvements in all symptoms among veterans with Gulf War Illness after one month on the dietary intervention. The main objectives of this study are: 1) to confirm previous findings of treatment response to the diet in a larger and more diverse group; 2) to examine how changes in the nervous system may be the reason for improvement; and 3) to identify markers which change in the blood after one month on the diet. Participants will have baseline measures collected and then will be randomized into the intervention or wait-listed control group, which they will follow for one month before being reassessed.
Contact:
Houra Taheri, Ph.D.
For more information, visit the link below:
Study Details | Confirmation of Diet as a Treatment for Gulf War Illness | ClinicalTrials.gov
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are:
- how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the GI and systemic/brain interface?
- how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).
Contact:
Nancy Klimas, M.D.For more information, visit the link below:
Amyotrophic lateral sclerosis
Combined Respiratory Training in Persons with ALS
The goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed:
- Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS.
- Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment.
- Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.
Contact:
Lauren Tabor Gray, Ph.D.
For more information, visit the link below:
Study Details | Combined Respiratory Training in Persons with ALS | ClinicalTrials.gov
Stress
Mitigating Response to Stressors in Pregnant Women
Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Second, this study aims to develop models that 1) assess the adverse health and biological effects of social factors on pregnant women who experience repeated or chronic stress, 2) address how stress can be mitigated in pregnant women from different backgrounds who experience high stress.
Contact:
Gesulla Cavanaugh, Ph.D., M.S., MPH
For more information, visit the link below:
Study Details | Mitigating Response to Stressors in Pregnant Women | ClinicalTrials.gov
The Student Wellness and Emotional Growth Resiliency (SWAG-R) Program (SWAG-R)
The purpose of this research study is to provide a free 6-week, online psychological coaching program to NSU undergraduate students to help with anxiety, depression, and stress, while improving quality of life and healthy coping skills.
Contact:
Principal Investigator
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Autism
Assessing the Gut Microbiome and Its Association With Pediatric Stress and Cognition
Using a metabolomics approach in combination with eye-tracking data, this research study proposes to gather evidence from two interrelated body systems (gut and brain) in order to assess how the microbiome is involved in stress modulated symptoms in children with autism and children exposed to repeated stress in comparison to a control group.
Contact:
Gesulla Cavanaugh, Ph.D.For more information, visit the link below:
Dental
Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in PALS
The main objective of the proposed study is to evaluate if oral intake of EN formula preceding Gtube placement will impact tolerance upon placement and feeding via Gtube in pALS. This single arm intervention study all participants will receive the intervention and researchers will utilize validated indicators combined with clinical expertise to assess gastrointestinal symptoms of feeding intolerance before and after the intervention.
The main questions this study aims to answer are:
- Wil participants meeting a greater percentage of their estimated nutritional needs at baseline present a slower disease progression rate and a lower incidence of GI symptoms of feeding intolerance when feeding via Gtube?
- Will there be significant change in feeding intolerance when oral intake of enteral nutrition formula precedes feeding via Gtube?
Contact:
Andrea Charvet, Ph.D., RDN, LDN
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Rh-PDGF vs EMD for Treatment of Intra-bony Defects
Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease, will be screened for inclusion. Only subjects who showed persistent deep probing depth associated with an intrabony defect will be included and will be randomly allocated to one of two treatment groups. One group will be treated using recombinant human platelet derived growth factor (GEM-21) (test) added to allogenic bone graft, second group will be treated using enamel matrix derivatives (EMD) (control) with allograft. Both groups will be treated using the same surgical protocol. Patients will be followed up for a period of 6 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.
Contact:
Arsalan Danesh, D.D.S
For more information, visit the link below:
Study Details | Rh-PDGF vs EMD for Treatment of Intra-bony Defects | ClinicalTrials.gov
Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: A Possible Solution for Alveolar Ridge Preservation?
The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared.
Contact:
Andee Goldstein, DMD
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Nutrition/Sports
Magnesium Supplementation on Body Composition
The goal of this interventional clinical trial is to learn if the supplementation of magnesium can affect body composition in physically active individuals between the ages of 18 and 30. The main question[s] it aims to answer [is/are]:
How does magnesium supplementation affect body composition in physically active individuals?
Participants will take a magnesium capsule once daily for 8 weeks, log their food intake into MyFitnessPal 3 days weekly for the 8 weeks, keep their physical activity consistent to their current regimen, and have 1 baseline appointment with 2 follow ups evenly dispersed (mid-point and post-intervention).
Contact:
Madison M Doten, B.S.
Study Details | Magnesium Supplementation on Body Composition | ClinicalTrials.gov
Optometry
Improving Glare and Visual Comfort for Patients With Visual Impairment
Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology can adapt to the amount of visible light in the environment, darkening the lenses in bright sunlight, and returning to regular tint in normal or dim environment.
Purpose of this study is to assess whether individuals with visual impairment may benefit from these lenses to minimize glare, light sensitivity symptoms, and improve the overall visual comfort.
Contact:
So Yeon Lee, OD
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Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games
Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. Our previous findings (see Publications) show that the adult amblyopic brain is still plastic and malleable, suggesting that active approach is potential useful in treating amblyopia.The goal of this project is to assess the limits and mechanisms of neural plasticity in both normal and amblyopic spatial vision. This study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia. Research participants will be asked to practice a visual discrimination task (perceptual learning) or to play video games with the amblyopic eye for a period of time. A range of visual functions will be monitored during the course of treatment.
Contact:
Roger W Li, OD, PhD
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A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics
The majority of young children do not think that visual field (VF) testing of peripheral vision is similar to a game; therefore, it is not surprising that they have difficulty maintaining attention during VF testing and thus the test reliability suffers as a consequence. Poor VF reliability has been a longstanding, major issue since it leads to an increased number of tests and/or longer duration of time needed to determine when there are true vision losses. Providers are less likely to obtain VF tests in children since the results are of doubtful value and challenging to interpret when they are inconsistent. Effectively this means that children with untreated, slowly progressive eye diseases may go undiagnosed and incur greater visual losses. The investigators aim to create a prototype device that the investigators hypothesize will make VF testing more engaging for young children, thus increasing their attention and consistency of their responses to the test stimuli, which in turn should improve VF reliability. The components include a microdisplay video screen (1.5" diameter) as the fixation target (instead of the standard LED light) displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon character voices presented by the test operator to provide instructional feedback based on the child's performance during testing. Improved VF reliability from the investigators intervention would translate to improved diagnosis and care for young childrens' peripheral vision loss through widespread implementation of the investigators innovative, affordable and readily adoptable system at eye care providers' offices.
Contact:
So Yeon Lee, O.D.
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Cardiology
Assessing Impacts of Static Magnetic Fields on Peripheral Pulses and Skin Blood Flow
A specific neodymium magnet and sham device will be placed on certain sites near the ulnar and medial arteries and the effect of such placement on peripheral pulses assessed via PPG on fingers and on skin blood flow via laser Doppler perfusion determined. These assessments will be made while healthy subjects are lying supine on a padded examination table over a time interval of about 45-60 minutes. In addition to the impact that either the magnet or the sham devices have, the pulse and skin blood flow patterns and features will be analyzed from the point of view of sequential variability with and eye toward developing related parameters to potentially improve such variability.
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Investigating Cardiac Health of Adults With Trauma (I - CHAT)
Considerable research has indicated strong associations between posttraumatic stress and cardiovascular disease (CVD) risk. Individuals with posttraumatic stress disorder (PTSD) tend to show patterns of elevated CVD risk earlier in life than in the general population. The need for developing effective interventions for CVD risk-reduction in PTSD is increasingly evident. In comparison to the cumulative evidence concerning elevated CVD risk in PTSD, relatively little research has addressed CVD risk-reduction in this population. Adjunctive treatments, such as health behavior interventions, may be necessary as supplements to traditional psychotherapy for PTSD in order to reduce CVD risks. The objective of the proposed project is to examine the effects of a healthy lifestyle intervention that addresses multiple CVD-related heath behaviors among civilian adults across genders (ages 18+), who evidence PTSD and CVD risk at baseline. The investigators will assess the intervention impact on both subjective and objective indices of health behaviors, cardiovascular risks and CVD markers over a one-year timeframe. The healthy lifestyle intervention addresses unique aspects of PTSD symptom presentation that serve as barriers to healthy behaviors (e.g., nightmares/sleep disruption, and cognitive responses to stress), while encouraging healthy lifestyle changes. The primary goal of the present study is to examine whether, compared to a usual care psychotherapy control condition, utilizing the healthy lifestyle intervention as an adjunct to psychotherapy will result in significantly reduced CVD risks and improved CVD markers among civilian adults with PTSD and elevated CVD risks. Therefore, participants will be randomly assigned to either a usual care psychotherapy-only control condition or a usual care psychotherapy plus healthy lifestyle intervention condition. Outcomes will be assessed at post-intervention (12 weeks), as well as 6-month and 12-month time points for follow-up evaluation.
Contact:
Shay MurphyFor more information, visit the link below:
Study Details | Investigating Cardiac Health of Adults With Trauma (I - CHAT) | ClinicalTrials.gov
Psychology
Substance Use Treatment and Its Role in Supporting Social Cognition (SUE)
Despite the lack of a consensus on the conceptualization of empathy among researchers and practitioners, psychologists generally agree that empathy and valuable interpersonal relations are contingent upon the willingness to understand another's perspective as well as share feelings and experiences. Adults with a variety of substance use disorders (SUDs) experience impairments in various facets of empathetic processing compared to healthy controls. Impairments in empathy could lead to a weak therapeutic alliance, lower adherence to treatment, and higher relapse rate. Furthermore, the therapeutic relationship has been described as one of the strongest predictors of treatment drop-out for patients with SUDs. In addition, an impaired ability to relate to and understand the affective and mental state of others may contribute to key typologies of patients with SUDs including, impulsivity, aggression, and antisocial behavior. Review of literature emphasizes a need for research into an understudied, yet modifiable factor of empathy in the trajectory of SUDs. Particularly, identifying specific psychotherapeutic techniques capable of improving the expression of empathy in these patients. Given the importance of empathetic ability in optimal social functioning, understanding whether empathetic impairments improve with treatment is important to achieve the best treatment outcomes for individuals struggling with SUDs.This study will help improve the knowledge and understanding of how substance use treatment affects empathy, as measured by gains in empathetic ability in treatment seeking individuals. To date, there are no reported studies that examined the impact of residential SU treatment on empathy. The study will be an observational quasi-experimental design that utilizes a pre-test and post-test to examine change in empathy for recently detoxed substance use patients and a follow-up assessment to monitor long term outcomes. The results of this study will further our understanding of treatment's potential role in cultivating a fundamental interpersonal skill, empathy.
Contact:
Madison Roopchand, MS
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