Behaviors and Mental Disorders

All Conditions

Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Trauma and Stressor Related Disorders

Mental Disorders

Psychotic Disorders

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was retained according to NIH criteria, familial forms were excluded. The French version of the Impact of Event Scale-Revised was used for the diagnosis of PTSD.

Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms

Questionnaires about: methods of announcement (who? when? how?)

Questions about look for information about disease

University Hospital, Brest

Ganglion Cysts

Synovial Cyst

Cysts

Psychological Trauma

Mucinoses

Connective Tissue Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Ropivacaine

Anesthetics, Local

Participants will receive 12 sessions of cognitive processing therapy (CPT) for PTSD combined with SGB during the first week of CPT.

Participant will receive 12 sessions of cognitive processing therapy (CPT) for PTSD and will receive SGB three months after completing the CPT sessions.

Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters. CPT is generally delivered over 12 sessions and helps patients learn how to challenge and modify unhelpful beliefs related to the trauma. In so doing, the patient creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life. This treatment is strongly recommended for the treatment of PTSD.

Cognitive Processing Therapy (CPT)

SGB is a procedure that has demonstrated efficacy for the reduction of PTSD symptoms. SGB is performed using real-time ultrasonography with an in-plane technique, and consists of 7-10 mL of ropivacaine 0.5%, which is injected around and into the site of the ganglion at the level of the C4 and C6 anterior tubercle (Mulvaney, Curtis et al., 2020). Ropivacaine is a long-acting amide local anesthetic agent and a pure S-enantiomer with a high pKa and relatively low solubility. Patients are not sedated during the procedure. Successful sympathetic blockade is confirmed by the presence of Horner's syndrome, which is characterized by constriction of the pupil (miosis) and drooping of the upper eyelid (ptosis). If Horner's syndrome is not observed within 20 minutes of the first injection, the right-sided SGB is repeated one hour later using the same technique. If Horner's syndrome is not confirmed after the second injection, no additional injections are provided.

Stellate Ganglion Block

Craig J Bryan, PsyD

Our long-term goal is to improve clinical outcomes among patients receiving psychological treatment for posttraumatic stress disorder (PTSD). The primary objective of this project is to examine if stellate ganglion block (SGB) improves outcomes among military personnel and veterans receiving cognitive processing therapy (CPT), an empirically-supported psychological treatment for PTSD. To accomplish this objective, we will enroll adult military personnel and veterans with a current diagnosis of PTSD and/or subthreshold PTSD, provide CPT sessions over two weeks, administer SGB during or after CPT, and repeatedly assess key outcomes during follow-up.

Posttraumatic stress disorder (PTSD) is the most frequently diagnosed mental health condition among veterans (Tanielian \& Jaycox, 2008), with estimated rates of the condition ranging from 5-20% (Hoge, Castro, et al., 2004; Hoge, Terhakopian, et al., 2007; Milliken, Auchterlonie, \& Hoge, 2007; Tanielian \& Jaycox, 2008). PTSD is not just a consequence of combat, however; many military personnel and veterans experience noncombat-related traumas such as sexual assault and domestic abuse, or have histories of early life trauma such as child abuse that can also contribute to PTSD. Regardless of the associated event, PTSD is associated with a host of functional problems and negative outcomes among military personnel including occupational and marital dissatisfaction, violence, alcohol and substance abuse, and suicide (Hoge et al., 2004; Jakupcak et al., 2007; Panagioti, Gooding, \& Tarrier, 2009).

Cognitive behavioral treatments are the most highly efficacious treatments for PTSD. Cognitive Processing Therapy (CPT) is one such treatment that has garnered a significant amount of empirical support, with a recent metaanalysis showing it was the most effective treatment for PTSD (Watts et al., 2013), typically yielding a 50% or larger reduction in PTSD symptoms from pre- to posttreatment. Despite CPT's effectiveness, a significant percentage of military veterans continue to experience moderate to severe symptoms afterwards, and nearly half continue to meet full criteria for the diagnosis (Harik, Grubbs, \& Schnurr, 2016). Novel strategies for improving treatment outcomes are therefore needed.

Accumulating evidence supports the effectiveness of stellate ganglion block (SGB) for the treatment of PTSD. SGB is a procedure in which an injection of a long-acting local anesthetic, using ultrasound or fluoroscopic guidance, is made in the right side of the neck around the cervical sympathetic chain that controls the "fight or flight" response (the sympathetic nervous system). The cervical sympathetic chain is a two-way conduit that connects the parts of the brain that control the fight or flight response to the rest of the body. By blocking or "turning off" the cervical sympathetic chain, it is believed that the parts of the brain that control the fight or flight response are allowed to completely reset, resulting in long-term relief of the associated anxiety symptoms. Originally developed for the treatment of pain conditions, multiple case series have shown that right-sided SGB is associated with significant reductions in PTSD symptoms after SGB (Alino et al., 2013; Hickey et al., 2012; Lipov et al., 2008; Mulvaney et al., 2010, 2014), especially negative mood and hyperarousal symptoms (Lynch et al., 2016). Results of a recent randomized controlled trial in which SGB was compared to sham treatment further support the procedure's efficacy (Olmsted et al., 2019). In that study, PTSD symptom reduction in the SGB group was twice as large as the sham group. Research also supports SGB's safety and acceptability among patients with combat-related PTSD (McLean, 2015).

To date, however, the effectiveness of SGB when delivered in combination with first-line PTSD treatments like CPT has not been examined. The present study is designed to examine this issue from two perspectives. First, we will examine if the administration of SGB during CPT leads to larger reductions in PTSD symptoms as compared to CPT alone. Second, we will examine if the administration of SGB after CPT leads to significant reductions in PTSD symptoms among veterans who continue to experience moderate to severe symptoms after completing the therapy. To achieve this the study entails a single-blind, randomized clinical trial with wait list control. All participants will receive cognitive processing therapy (CPT), an empirically-supported psychological (non-medication) treatment for PTSD. Participants will be randomly assigned to receive stellate ganglion block (SGB) treatment at one of two time points: (1) during CPT or (2) three months after completing CPT. Outcomes will be assessed repeatedly for six months postbaseline.

All participants receive cognitive processing therapy during weeks 1 and 2. Participants will be randomly allocated to receive SGB during or 3 months after CPT.

Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD

Researchers interested in using IPD and/or computer code collected or generated as part of this study may do so by contacting the study PI. Researchers will be asked to complete a Data Use Request Form, which includes contact information, description of the research project for which the data and/or code would be used, specification of which data and/or code would be needed for their proposed project, an approximate time line for their proposed project, and authorship on their proposed project.

PTSD symptom severity will be assessed using PTSD PCL-5. The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.

Severity will be measured using the Patient Health Questionnaire-9 (PHQ-9). The scale includes 9 items that rate the severity of each symptom using a 4-point scale, with items summed to provide an overall metric of depression symptom severity.

Severity will be measured using the Generalized Anxiety Disorder-7 (GAD-7) scale. The scale includes 7 items that rate the severity of each symptom using a 4-point scale, with items summed to provide an overall metric of anxiety symptom severity.

Symptoms will be measured using the Patient Health Questionnaire-15 (PHQ-15). The PHQ-15 is designed to assess the severity of 15 somatic/physical symptoms using a 3-point scale. Items can be summed to provide an overall metric of somatic symptoms and side effects.

Good end-state functioning is defined as having very low symptoms of both PTSD and depression, and is operationalized as a PCL-5 total score \< 20 and a PHQ-9 total score \< 10. It will be measured using a combination of these scores.

The Stellate Institute

Navy SEAL Foundation

Ohio State University

Stress, Trauma, and Resilience (STAR) Professor

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

COVID-19

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months.

Psychological support

Antony NARAYANASSAMY, M

In the context of the COVID-19 pandemic, concerns of the risk of infection may lead to fear, anxiety or psychological disorders that may become generalised and long-lasting, corresponding to post-traumatic stress disorder (PTSD). PTSD generally occurs in circumstances such as terrorist attacks, hostage-taking, bombings, aggression, accidents... The current health crisis also represents an increased risk of PTSD.

After the first moments of stress, the illness becomes more diffuse: personality change (introverted/extraverted), sleep disorders, heart problems, hypervigilance reaction, agoraphobia, symptoms of reminiscence, irritability, decreased concentration, memory loss... In some people, PTSD can lead to more disabling problems such as (crowd) avoidance.

In order to help patients with PTSD, clinical psychology offers therapeutic approaches which, starting from a debriefing with the patient, provide supportive therapy which (i) reassures by providing information on the symptomatology, in order to play down the present state of mind, (ii) allows for the expression of what was experienced during the event, (iii) initiates a process of elaboration of the trauma through transference.

A study initiated at the François Baclesse Centre during the first confinement, which included 735 patients from April to June 2020, made it possible to assess the impact of the pandemic linked to COVID-19 on the care of cancer patients treated in day hospitals, but also to evaluate the PTSD experienced by patients, sleep difficulties, quality of life, cognitive complaints and confinement conditions using validated questionnaires. This study showed that 21% of patients had proven PTSD and 23% had insomnia problem.

This study proposes to evaluate the value of adapted psychological care for patients with PTSD in relation to the pandemic on the improvement of PTSD, as well as on resilience, quality of life and sleep.

Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19

Done with Connor-Davidson Resiliency Scale

Centre Francois Baclesse

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Eye Diseases

Immune System Diseases

Heart and Blood Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Dementia

Uterine Cervical Neoplasms

Alzheimer Disease

Macular Degeneration

Parkinson Disease

Lewy Body Disease

Paralysis

Parkinsonian Disorders

Diabetes Mellitus, Type 1

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Sclerosis

Multiple Sclerosis

Atrophy

Vaginal Neoplasms

Vulvar Neoplasms

Motor Neuron Disease

Amyotrophic Lateral Sclerosis

Huntington Disease

Uterine Neoplasms

Frontotemporal Dementia

Aphasia, Primary Progressive

Pick Disease of the Brain

Supranuclear Palsy, Progressive

Corticobasal Degeneration

Multiple System Atrophy

Shy-Drager Syndrome

Neuronal Ceroid-Lipofuscinoses

Aphasia

Late Onset Disorders

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Movement Disorders

Synucleinopathies

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Tauopathies

Neurocognitive Disorders

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Uterine Cervical Diseases

Uterine Diseases

Retinal Degeneration

Retinal Diseases

Pathological Conditions, Anatomical

Spinal Cord Diseases

TDP-43 Proteinopathies

Proteostasis Deficiencies

Chorea

Dyskinesias

Cognition Disorders

Vulvar Diseases

Autonomic Nervous System Diseases

Primary Dysautonomias

Hypotension

Vascular Diseases

Frontotemporal Lobar Degeneration

Speech Disorders

Language Disorders

Communication Disorders

Neurobehavioral Manifestations

Neurologic Manifestations

Ophthalmoplegia

Ocular Motility Disorders

Cranial Nerve Diseases

Vaginal Diseases

Lipidoses

Subjects in this group will have a diagnosis and/or medical history of a condition, disease, genetic background, or trait of interest.

Subjects in this group will serve as healthy controls.

Skin biopsy (2-3mm) and/or blood (up to 50 mL); saliva; excess/ leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure).

Biological Sample Collection

Becca Wood

Lisa Voltolina

Scott Noggle

The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate diverse disease research using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and store the samples for future use.

Through this research, researchers hope to identify future treatments or even cures for the major diseases of our time.

Researchers at the New York Stem Cell Foundation (NYSCF) Research Institute study diverse diseases, conditions, and traits by creating stem cells from biological samples. These "pluripotent" stem cells can become any cell in the human body, including cells that may be difficult, invasive, or impossible to obtain directly.

Additionally, researchers perform genetic testing to learn more about DNA, a material in most cells that contains instructions for the body's development and functions (such as traits like eye color and risk of certain diseases). A piece of DNA that determines the specific role of a cell is called a "gene." If the instructions in a gene are abnormal, this can lead to disease.

Participation in the study involves: (1) completion of health questionnaires, (2) providing a skin and/or blood sample from which stem cells may be created, (3) collection of a saliva sample for genetic analysis, and (4) possible future followup to provide additional information or learn about other research studies.

This study is not a clinical trial.

Skin biopsy (2-3mm) and/or blood (up to 50 mL); saliva; excess/leftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure)

NYSCF Scientific Discovery Biobank

Establishment of a diverse repository of biological samples, stem cell lines, derivatives, and associated information to support investigations into the biology, etiology, manifestations, progression, risk factors, genetic underpinnings, and treatment of diseases, conditions, and traits.

New York Stem Cell Foundation Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms	NCT03298438	Neurofibromatos... Diagnoses Disea... Post Traumatic ...		18 Years -	University Hospital, Brest
Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD	NCT05107752	PTSD Trauma and Stre... Trauma, Psychol... Post Traumatic ...	Cognitive Proce... Stellate Gangli...	18 Years -	Ohio State University
Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19	NCT04747249	Solid Carcinoma Post Traumatic ... Covid19	Psychological s...	18 Years -	Centre Francois Baclesse
Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19	NCT04747249	Solid Carcinoma Post Traumatic ... Covid19	Psychological s...	18 Years -	Centre Francois Baclesse
NYSCF Scientific Discovery Biobank	NCT06203106	ALS Amyotrophic Lat... Alzheimer Disea... Alzheimer Disea... Alzheimer Disea... Batten Disease Corticobasal De... Dementia Frontotemporal ... Huntington Dise... Lewy Body Disea... Multiple Sclero... Multiple System... Parkinson Disea... Parkinson's Dis... Progressive Sup... INAD Diabetes Diabetes Mellit... Diabetes Mellit... Diabetes Mellit... Macular Degener... Ovarian Cancer Cervical Cancer Uterine Cancer Vaginal Cancer Vulvar Cancer PTSD Post Traumatic ...	Biological Samp...	30 Days -	New York Stem Cell Foundation Research Institute
Study About Annoucement of the Diagnosis of Neurofibromatosis 1 in de Novo Forms	NCT03298438	Neurofibromatos... Diagnoses Disea... Post Traumatic ...		18 Years -	University Hospital, Brest

Spots Global Cancer Trial Database for post traumatic stress disorder