Clinical trials: Skull
Intracranial Neoplasm
Accuracy of Robotically Assisted Cranial Biopsies
This is an observational post-market study determining biopsy accuracy in a clinical environment using Cirq® Robotic Alignment Module Cranial.
- Trial name
- NCT05891002
- Testing
- Cirq® Robotic Alignment Module Cranial
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Brainlab AG
Cerebrospinal Fluid Leaks
TASALL - TachoSil® Against Liquor Leak
The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively.
- Trial name
- NCT01355627
- Testing
- TachoSil®, Current Practice
- Where
- 39 sites in Austria, Belgium and 9 more
- Volunteers
- 726 people
- Sponsor
- Takeda
Anterior Ischemic Optic Neuropathy, Ischemic Optic Neuropathy
Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
The objectives of this study were to: (1) evaluate the natural history of non-arteritic anterior ischemic optic neuropathy (NAION); (2) estimate the population incidence of NAION; and (3) identify potential risk factors for NAION.
- Trial name
- NCT01260324
- Testing
- No intervention given in this observational study
- Volunteers
- 21,283 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Anxiety, Depression
Effectiveness of CES on Emotional and Cellular Wellbeing
The investigators aim to use a CES (cranial electrotherapy stimulation) intervention to improve emotional well-being by reducing symptoms of anxiety and depression and to assess for changes in markers of cellular health …
- Trial name
- NCT03369418
- Testing
- Alpha-Stim Active, Alpha-Stim Inactive
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Vestibular Schwannoma, Meningioma
Exploratory Evaluation of AR-42 Histone Deacetylase Inhibitor in the Treatment of Vestibular Schwannoma and Meningioma
This will be a multi-center, proof of concept phase 0 study to assess the suppression of p-AKT in Vestibular Schwannoma (VS) and meningiomas by AR-42 in adult patients undergoing tumor resection.
- Conditions
- Vestibular Schwannoma, Meningioma, Acoustic Neuroma, Neurofibromatosis Type 2
- Trial name
- NCT02282917
- Testing
- AR-42
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- Massachusetts Eye and Ear Infirmary
Head and Neck Cancer
Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00509665
- Testing
- doxorubicin hydrochloride, gemcitabine hydrochloride
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Medical University of South Carolina
Surgical Complication, Paresthesia
Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw.
- Conditions
- Surgical Complication, Paresthesia, Fracture, Nerve Injury
- Trial name
- NCT05205616
- Testing
- Sonopet ultrasonic saw, Reciprocating saw
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Blepharospasm, Torticollis
MDs on Botox Utility (MOBILITY)
The MOBILITY Project is a prospective, non-randomized, observational, multi-centre evaluation of Health Utility via the SF-12® Health Survey Scores and the SF-6D in patients receiving BOTOX® for therapeutic use.
- Conditions
- Blepharospasm, Torticollis, Strabismus, Muscle Spasticity
- Trial name
- NCT00535938
- Testing
- botulinum toxin type A
- Where
- Canada
- Volunteers
- 1,372 people
- Sponsor
- Allergan
Neurofibromatosis Type 2, Vestibular Schwannomas
Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas
The purpose of this study is to determine if the study drug, AXITINIB, has any effect on tumors found in patients with Neurofibromatosis Type 2 (NF2).
- Trial name
- NCT02129647
- Testing
- Axitinib
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- NYU Langone Health
Elective Cranial Procedures With Dural Incision
DuraSeal Sealant Post Market Study
DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as…
- Trial name
- NCT00704340
- Testing
- DuraSeal Dural Sealant System, Standard of Care
- Where
- United States
- Volunteers
- 237 people
- Sponsor
- Integra LifeSciences Corporation
Dystonia
Deep Brain Stimulation in Patients With Dystonia
The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.
- Trial name
- STN DBS (NCT00773604)
- Testing
- Medtronic implantable deep brain stimulation (DBS) system
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- University of California, San Francisco
Depression, Anxiety
The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety Among Homeless Adults
This is a trial of the use of cranial electrostimulating therapy for depression and anxiety among homeless adults.
- Trial name
- NCT02732561
- Testing
- Alpha Stim device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Wake Forest University Health Sciences
Leber's Congenital Amaurosis
Study to Evaluate QR-110 in Leber's Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene
The purpose of this study is to evaluate the safety and tolerability of QR-110 administered via intravitreal injection in subjects with LCA due to the CEP290 p.Cys998X mutation.
- Trial name
- NCT03140969
- Testing
- QR-110
- Where
- 3 sites in United States, Belgium
- Volunteers
- 11 people
- Sponsor
- Laboratoires Thea
Intracranial Aneurysm
Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy
This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial…
- Trial name
- SHIELD (NCT02719522)
- Testing
- Pipeline™ Flex Embolization Device with Shield Technology™
- Where
- 21 sites in Australia, Denmark and 9 more
- Volunteers
- 205 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Optic, Atrophy, Hereditary, Leber
Efficacy Study of GS010 for Treatment of Vision Loss From 7 Months to 1 Year From Onset in LHON Due to the ND4 Mutation (REVERSE)
The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in improving the visual outcome in participants with Leber Hereditary Optic Neuropathy (LHON) due to the G11778A ND4 mitochondrial mutation…
- Trial name
- REVERSE (NCT02652780)
- Testing
- GS010
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 37 people
- Sponsor
- GenSight Biologics
Relapsing-remitting Multiple Sclerosis
Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis
The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and…
- Trial name
- NCT00879658
- Testing
- BAF312
- Where
- 72 sites in United States, Canada and 10 more
- Volunteers
- 297 people
- Sponsor
- Novartis Pharmaceuticals
Oromandibular Dystonia, Cranial Dystonia
Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia
Background: People with dystonia cannot control their muscle contractions. This disorder can affect different body areas. When it affects the face, tongue, and jaw, it is called oromandibular dystonia (OMD) or cranial dystonia…
- Trial name
- NCT02199509
- Testing
- Levetiracetam
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Neurofibromatosis Type 1, Recurrent Childhood Pilocytic Astrocytoma
Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma
This randomized phase II trial studies how well low-dose lenalidomide works compared with high-dose lenalidomide in treating younger patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas that have come back…
- Conditions
- Neurofibromatosis Type 1, Recurrent Childhood Pilocytic Astrocytoma, Recurrent Childhood Visual Pathway Glioma
- Trial name
- NCT01553149
- Testing
- Lenalidomide, Pharmacological Study
- Where
- 126 sites in United States, Australia and 2 more
- Volunteers
- 75 people
- Sponsor
- National Cancer Institute (NCI)
Vestibular Schwannoma, Neurofibromatosis Type 2
Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2)
People who have neurofibromatosis type 2 (NF2) can have tumors that grow on the auditory nerves and cause hearing loss. These tumors are called vestibular schwannomas (VSs), or acoustic neuromas.
- Trial name
- NCT01207687
- Testing
- bevacizumab, laboratory biomarker analysis, quality-of-life assessment
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Cancer Institute (NCI)