Clinical trials: Traumatic Injuries
Traumatic Brain Injury
Evaluation of Mild TBI in Collegiate Athletes
The purpose of this study is to evaluate blood-based biomarkers before and after sports-induced concussion using neuroimaging and head impact sensor technology.
- Trial name
- AWARE (NCT02189525)
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Banyan Biomarkers, Inc
Traumatic Brain Injury
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
- Trial name
- NCT00893789
- Testing
- Armodafinil
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 117 people
- Sponsor
- Cephalon, Inc.
Posttraumatic Stress Disorder
Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD
The goal of this clinical trial is to learn if MDMA in combination with therapy is safe and effective in people with chronic, treatment-resistant PTSD.
- Trial name
- NCT01793610
- Testing
- Comparator Dose (40mg) MDMA HCl, Active Dose 2 (100 mg) MDMA HCl, Active Dose 1 (125 mg) MDMA HCl
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Resilient Pharmaceuticals
Traumatic Brain Injury
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure…
- Trial name
- NCT05951777
- Testing
- Autologous HB-adMSCs, Normal Saline
- Where
- 2 sites in United States
- Volunteers
- 51 people
- Sponsor
- Hope Biosciences LLC
Posttraumatic Stress Disorder
Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel
The goal of this clinical trial is to learn if MDMA-assisted therapy can treat PTSD in participants with PTSD. Researchers will compare two sessions of MDMA-assisted therapy with two sessions of low dose (active placebo)…
- Trial name
- NCT00402298
- Testing
- Full Dose Midomafetamine HCl, Low Dose Midomafetamine HCl
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Resilient Pharmaceuticals
Traumatic Brain Injury
Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
- Trial name
- NCT01357421
- Testing
- TT301
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
TBI (Traumatic Brain Injury)
Traumatic Brain Injury in Veterans and Near-Infrared Phototherapy
This is a proof-of-concept study designed to demonstrate whether increases in cerebral blood flow, improvements in brain functioning, and reductions in symptomology associated with traumatic brain injury (TBI) can result from…
- Trial name
- NCT02635516
- Testing
- Near-Infrared Phototherapy
- Volunteers
- 13 people
- Sponsor
- Cerehealth Corp.
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or…
- Trial name
- PATTERN (NCT03992404)
- Testing
- NT 201
- Where
- 71 sites in United States, Belgium and 13 more
- Volunteers
- 603 people
- Sponsor
- Merz Pharmaceuticals GmbH
Concussion, Mild
Pro-2-Cool Pivotal Trial II
This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by…
- Trial name
- NCT06929923
- Testing
- Pro2Cool Device
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- TecTraum Inc.
Subdural Hematoma, Chronic
The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for…
- Trial name
- STEM (NCT04410146)
- Testing
- SQUID Embolization, SQUID Embolization and Surgical Evacuation, Surgical Evacuation
- Where
- 32 sites in United States, France and 2 more
- Volunteers
- 319 people
- Sponsor
- Balt USA
Pain
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl treatment compared to placebo treatment monthly over a 12-week treatment period in alleviating breakthrough pain (BTP) in opioid-tolerant…
- Trial name
- NCT00343733
- Testing
- OraVescent Fentanyl
- Where
- 21 sites in United States
- Volunteers
- 120 people
- Sponsor
- Cephalon
Post-traumatic Stress Disorder
Effectiveness of a Blended Care Parenting Intervention for Parents With PTSD (KopOpOuders-PTSD)
KopOpOuders-PTSD is a new preventive blended care intervention for parents with PTSD. The purpose of this study is to evaluate its effectiveness in improving parenting and preventing child mental health problems.
- Trial name
- NCT05237999
- Testing
- KopOpOuders-PTSD
- Where
- Netherlands
- Volunteers
- 142 people
- Sponsor
- Arkin
Nervous System Disorders
Dysport® Adult Upper Limb Spasticity
The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.
- Trial name
- NCT01313299
- Testing
- Botulinum toxin type A
- Where
- 40 sites in United States, Belgium and 7 more
- Volunteers
- 243 people
- Sponsor
- Ipsen
Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in…
- Trial name
- OSsIRIS (NCT06156904)
- Testing
- Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 135 people
- Sponsor
- GreenBone Ortho S.p.A.
Mild Traumatic Brain Injury
Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury
The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while helping to establish assessment…
- Trial name
- NCT05337774
- Testing
- [18F]PI-2620
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Life Molecular Imaging SA.
Neurologic Disorders, Nervous System Diseases
Neurologic Stem Cell Treatment Study
This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will…
- Conditions
- Neurologic Disorders, Nervous System Diseases, Neurodegenerative Diseases, Neurological Disorders
- Trial name
- NEST (NCT02795052)
- Testing
- Intravenous and Intranasal BMSC
- Where
- 3 sites in United States, United Arab Emirates
- Volunteers
- 500 people
- Sponsor
- MD Stem Cells
Neuralgia
P4 (Pregabalin for Peripheral Posttraumatic Pain)
To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
- Trial name
- P4 (NCT00292188)
- Testing
- pregabalin
- Where
- 44 sites in Belgium, Canada and 9 more
- Volunteers
- 255 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pain, Pain Syndrome
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates…
- Conditions
- Pain, Pain Syndrome, Pain, Chronic, Chronic Pain
- Trial name
- NCT06071949
- Testing
- Adezunap
- Where
- Germany
- Volunteers
- 558 people
- Sponsor
- Apurano Pharmaceuticals GmbH
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT06194838
- Testing
- Ossur Power Knee, Reboocon Intuy Knee
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Liberating Technologies, Inc.
Traumatic Brain Injury
Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)
This is a Phase 1, multi-center, randomized, double-blind, placebo-controlled, multiple-ascending- dose trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of intravenous PNT001 in hospitalized…
- Trial name
- NCT04677829
- Testing
- PNT001, %5 dextrose for infusion
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pinteon Therapeutics, Inc