Clinical trials: Injuries, Head
Skull Fractures
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer.
- Trial name
- CRANFLAP (NCT05119595)
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Aesculap AG
Facial Injuries, Tissue Injury
Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using TGI Device
The overall purpose of this research is to evaluate the physical changes that occur over time after fat grafting for craniofacial trauma.
- Trial name
- AFIRM-TGI (NCT01924364)
- Testing
- Tissue Genesis Cell Isolation System™ (TGI CIS), Standard of care fat grafting
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- J. Peter Rubin, MD
Mild Traumatic Brain Injury
Remediation of Impaired Self-Regulation in Patients With Mild TBI
The ability to regulate impulses enables us to plan for the future, to maintain focus in the face of distractions (i.e. to encode memories), and to manage emotions.
- Trial name
- NCT02260570
- Testing
- Tolcapone
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
TBI (Traumatic Brain Injury)
Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation.
- Trial name
- NCT02881151
- Testing
- Deep brain stimulation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Jaimie M. Henderson
Head and Neck Cancer, Radiation Dermatitis
Study of KeraStat Cream for Radiation Dermatitis During Head and Neck Radiotherapy
This is a single site, randomized, open-label comparison pilot study to assess the feasibility and effectiveness of KeraStat Cream compared with routine skin care (RSC) in managing radiotherapy-induced early adverse skin reaction…
- Trial name
- NCT04173247
- Testing
- KeraStat Cream, Routine Skin Care - Commercially Available Agents
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Wake Forest University Health Sciences
Traumatic Brain Injury, Subarachnoid Hemorrhage
Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
Neurocritical ill patients are frequently transfused. Red blood cell transfusion (RBCT) in these patients has been associated with deleterious effects, including higher rates of nosocomial infections, multi-organ failure, and…
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
- Trial name
- NCT00566709
- Testing
- Red blood cells transfusion
- Where
- Spain
- Volunteers
- 102 people
- Sponsor
- Hospitales Universitarios Virgen del Rocío
Parotid Neoplasm, Thyroid Neoplasms
Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery
- Conditions
- Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms, Surgery
- Trial name
- NCT04420689
- Testing
- Bevonescein
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Alume Biosciences, Inc.
Chronic Post-traumatic Headache, Mild Traumatic Brain Injury
Acupuncture in Traumatic Brain Injury
The purpose of the study is to determine the effect of a low vs. high dose of acupuncture treatment in individuals with chronic post-traumatic headache (CPTH).
- Trial name
- AccuTBI (NCT04369911)
- Testing
- Acupuncture
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- HealthPartners Institute
Post-traumatic Headache
Sumatriptan as Treatment for Post-traumatic Headache
This phase II evaluation of sumatriptan as a treatment for post traumatic headache (PTH) will examine the methods and approach necessary to take the next step to a phase III trial.
- Trial name
- TWIST (NCT01854385)
- Testing
- Sumatriptan 100 mg
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Washington
Traumatic Brain Injury
Hyperbaric Treatment of Traumatic Brain Injury (TBI)
This study is designed to test the hypothesis that patients with Traumatic Brain Injury (TBI)treated with Hyperbaric (HBO) will show improvement in function and an increased blood flow as evidenced by single-photon emission…
- Trial name
- TBI (NCT01847755)
- Testing
- Oxygen at 1.5 ATA (atmospheres absolute).
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Barry Miskin, MD
Severe Traumatic Brain Injury
Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (TBI)
Traumatic brain injury (TBI) is a major cause of death and disability, with an estimated cost of 45 billion dollars a year in the United States alone.
- Trial name
- BOOST 2 (NCT00974259)
- Testing
- Management protocol based on pBrO2 and ICP values., Management protocol based on ICP values only.
- Where
- 10 sites in United States
- Volunteers
- 122 people
- Sponsor
- University of Pennsylvania
Head Injuries, Facial Injuries
Impact of Helmet Use in Preschool Children
To test the hypothesis if provision of helmet education and free helmet distribution will significantly increase helmet use in preschool children of low-income families compared to those children receiving helmet education…
- Trial name
- NCT01054846
- Testing
- Bicycle helmet from Bell Sports Inc., Bicycle helmet education only
- Where
- United States
- Volunteers
- 609 people
- Sponsor
- Parkview Hospital, Indiana
Brain Injury, Aggression
Amantadine for the Treatment of Traumatic Brain Injury Irritability and Aggression: A Multi-site Study
The purpose of this study is to study the effect of amantadine on irritability and aggression caused by traumatic brain injury.
- Trial name
- NCT00779324
- Testing
- Amantadine Hydrochloride
- Where
- 6 sites in United States
- Volunteers
- 168 people
- Sponsor
- Wake Forest University Health Sciences
Concussion
Smart Phone Application for Postconcussion Symptom Reduction
The proposed study will address a very important issue for the VA both currently and in the future -- the high percentage of OIF/OEF/OND Veterans who have been medically diagnosed with a mild traumatic brain injury (mild TBI) and…
- Trial name
- NCT02501642
- Testing
- Concussion Coach, Treatment as usual
- Where
- 2 sites in United States
- Volunteers
- 479 people
- Sponsor
- VA Office of Research and Development
Traumatic Brain Injury
The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.
- Trial name
- BIS-TBI (NCT03575169)
- Testing
- BIS Monitor
- Where
- 4 sites in United Kingdom
- Volunteers
- 26 people
- Sponsor
- University of Aberdeen
Brain Concussion, Blast Injuries
Metacognitive Training to Enhance Strategy Use in Blast-Related TBI
Enhanced Goal Management Training (GMT) is a 10-week group or individual therapy that teaches strategies to improve an individual's ability to complete everyday tasks.
- Trial name
- NCT00857207
- Testing
- Goal Management Training
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- VA Office of Research and Development
Dural Tear, Cerebrospinal Fluid Leak
A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
The objective of this study was to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in subjects requiring Dural repair following neurosurgery.
- Trial name
- NEOART (NCT04145544)
- Testing
- Implantation of the ArtiFascia®, Implantation of other commercial suturable dural substitute
- Where
- 9 sites in Belgium, Czechia and 3 more
- Volunteers
- 92 people
- Sponsor
- Nurami Medical Ltd
PTSD, TBI (Traumatic Brain Injury)
Top-Down Executive Control in Traumatic Brain Injury (TBI), PTSD and Combined
This research investigates processes involved with one being able to focus on relevant information and ignore non-relevant information in veterans with PTSD and those with a history of traumatic brain injury.
- Trial name
- NCT01072006
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Anosmia, Head Trauma
NAC for Head Trauma-induced Anosmia
This study will compare administration of N-Acetyl Cysteine (NAC) versus placebo for the treatment of olfactory loss due to head injury.
- Trial name
- NCT03680911
- Testing
- N Acetyl Cysteine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Miami
Cutaneous Sutures and Scar Cosmesis
Suturing Distance From the Wound Edge, 2 mm vs 5 mm
This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck.
- Trial name
- NCT03330041
- Testing
- Fast absorbing gut suture
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, Davis