Clinical trials: Traumatic Injuries
Apnea, Sleep, Brain Injury, Traumatic
Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome
Background: Sleep disorders, including sleep apnea, are common after traumatic brain injury and affect recovery and negatively influence participation in rehabilitation.
- Trial name
- C-SAS (NCT03033901)
- Testing
- Polysomnography - Level 1 and Level 3, Actigraphy monitoring, Sleep Apnea Screening
- Where
- 6 sites in United States
- Volunteers
- 345 people
- Sponsor
- James A. Haley Veterans Administration Hospital
Anxiety, PTSD
A Placebo-Controlled Study of Mirtazapine for PTSD
Objective: To study the efficacy and tolerability of mirtazapine (Remeron) in the treatment of PTSD. Research Design: This is an 8-week randomized, double-blind, placebo-controlled treatment trial of mirtazapine for the treatment…
- Trial name
- NCT00302107
- Testing
- Mirtazapine
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Traumatic Brain Injury
Effects of Huperzine A in Treatment of Moderate to Severe TBI
We will explore the use of Huperzine A in patients who have sustained a moderate to severe Traumatic Brain Injury. We aim to determine whether Huperzine A, as compared with placebo, would have an effect on memory function after…
- Trial name
- NCT01676311
- Testing
- Huperzine A
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Spaulding Rehabilitation Hospital
Concussion Injury of Cerebrum, Cranial Osteopathic Medicine
Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion
Patients who have concussions exhibit an array of symptoms, also known as post-concussive symptoms, including headaches, feeling slowed down or foggy and difficulty with concentration.
- Trial name
- NCT03225599
- Testing
- Cranial Osteopathic Manipulative Medicine
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Northwell Health
PTSD
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine.
- Trial name
- RECOVERY (NCT03841773)
- Testing
- TNX-102 SL
- Where
- 30 sites in United States
- Volunteers
- 192 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Alcohol Dependence, Alcoholism
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans.
- Conditions
- Alcohol Dependence, Alcoholism, Alcohol Abuse, Alcohol Use Disorder
- Trial name
- NCT01408641
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Maryland, Baltimore
PTSD
Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function
The purpose of this study is to first adapt Cognitive Behavioral Conjoint Therapy for PTSD for Operation Enduring Freedom and Operation Iraqi Freedom (OEF-OIF) Veterans diagnosed with PTSD and their intimate partners by (1)…
- Trial name
- NCT01035788
- Testing
- Mindfulness Based Cognitive Behavioral Conjoint Therapy, CBCT for PTSD - Communication Skills
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- VA Office of Research and Development
Stress Disorders, Post-Traumatic, Helping Behavior
Clinical Trial of a Supporter-Targeted Intervention to Improve Outcomes in Recent Sexual Assault Survivors
Communication and Recovery Enhancement (CARE) is a 2-session early intervention for survivors of recent sexual assault and their supporters that aims to improve supporters' ability to respond effectively.
- Conditions
- Stress Disorders, Post-Traumatic, Helping Behavior, Help-Seeking Behavior, Stress
- Trial name
- CARE (NCT05345405)
- Testing
- Dyadic CARE, Supporter-Only CARE
- Where
- United States
- Volunteers
- 128 people
- Sponsor
- University of Washington
Chronic Posttraumatic Stress Disorder
Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)
Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a traumatic event and intense, persistent feelings of anxiety.
- Trial name
- HELP (NCT01188694)
- Testing
- Psychotherapy plus Methylene Blue, USP, Delayed Psychotherapy
- Where
- 3 sites in United States
- Volunteers
- 42 people
- Sponsor
- University of Washington
Post-stroke Spasticity, Spasticity Post-Traumatic Brain Injury
Dysport® Adult Lower Limb Spasticity Follow-on Study
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
- Trial name
- NCT01251367
- Testing
- Botulinum toxin type A
- Where
- 50 sites in United States, Australia and 9 more
- Volunteers
- 352 people
- Sponsor
- Ipsen
MTBI - Mild Traumatic Brain Injury, Anxiety
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2.
- Trial name
- NCT05524402
- Testing
- TOR-C 1, TOR-C 2
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Traumatic Brain Injury
Evaluation of VA's Traumatic Brain Injury (TBI) Clinical Reminder and Comprehensive TBI Evaluation (CTBIE)
The purpose of the proposed study is to determine the clinical validity and reliability of the VA's Traumatic Brain Injury (TBI) Clinical Reminder Screen and the Comprehensive TBI Evaluation used to screen for mild traumatic…
- Trial name
- TBI (NCT00852527)
- Where
- 3 sites in United States
- Volunteers
- 456 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Chronic Traumatic Encephalopathy
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
- Trial name
- NCT02079766
- Testing
- florbetapir F 18, Flortaucipir F18
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Posttraumatic Stress Disorder (PTSD)
Two Stepped Care Models for Posttraumatic Stress Disorder (PTSD) Among Cambodian Refugees With PTSD
This project aims to investigate the efficacy of two models to treat Posttraumatic Stress Disorder (PTSD) for Cambodian refugees in primary care.
- Trial name
- NCT01542372
- Testing
- Medication augmentation, CBT
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Massachusetts General Hospital
Stress Disorders, Post-Traumatic
A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
- Trial name
- NCT03033069
- Testing
- Brexpiprazole, Sertraline
- Where
- 54 sites in United States
- Volunteers
- 336 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
PTSD, Substance Use Disorders
Cognitive Behavioral Therapy (CBT) for PTSD in Veterans With Co-Occurring SUDs
With this research, the investigators hope to learn if cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD) works in people who have both PTSD and problems with drugs or alcohol.
- Trial name
- CBT (NCT01357577)
- Testing
- Cognitive behavioral therapy for PTSD
- Where
- 3 sites in United States
- Volunteers
- 129 people
- Sponsor
- VA Office of Research and Development
Neurobehavioral Disinhibition
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury…
- Trial name
- NCT03095066
- Testing
- AVP-786-28, AVP-786-42.63
- Where
- 54 sites in United States
- Volunteers
- 168 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Stress Disorders, Post-traumatic
Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups
The purpose of this study is to determine whether the participation in a group program which includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques will…
- Trial name
- NCT00136357
- Testing
- Mind-Body Skills Groups
- Where
- Federal Republic of Yugoslavia
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- The Center for Mind-Body Medicine
Post-operative Craniotomy Patients, Carotid Endarterectomy and Carotid Artery Stenosis Patients
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain. To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients.
- Conditions
- Post-operative Craniotomy Patients, Carotid Endarterectomy and Carotid Artery Stenosis Patients, Post-op Spine Patients Admitted to the NCCU, Endovascular Patients Undergoing Intracranial Intervention
- Trial name
- NCT01948505
- Testing
- Intravenous acetaminophen
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- University of Utah
Mental Health, Depression
Designing a Mobile App to Support Academic Success for Student Veterans
Compared to civilian students in higher education, student Veterans have high rates of mental health disorders (e.g., Depression: 24% vs 12.1%).
- Conditions
- Mental Health, Depression, Post-Traumatic Stress Disorder, Anxiety
- Trial name
- NCT05344092
- Testing
- VetEd Mobile Application
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development