Neurology: Clinical Studies Open For Enrollment
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Eligibility
- Patient is between 12-17 years of age
- Disabling motor simple partial seizures, complex partial seizures and/or secondary generalized seizures
- Seizures that are distinct, stereotypical event that can be reliably counted
- Subject had an average of three or more disabling seizures and/or generalized seizures over the two most recent consecutive 30 days.
- Subject failed treatment with a minimum of 2 AED (anti-epileptic drugs)
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT04839601
Principal Investigator
Steven Wolf, MD
Contact for Study Screening
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Eligibility
- Male or female, Aged ≥18 years on the index date
- Admitted to the hospital with an acute major bleeding or developed an acute bleeding while already in hospital
- Ongoing treatment with a Factor Xa inhibitor before the index date
- Provided signed and dated informed consent or able to obtain a waiver
- In addition, for cohort B:
- Administered reversal or replacement therapy
- Exclusion Criteria
- Pregnant women
- Patients enrolled in any interventional trial that includes reversal/replacement agents
- In addition, for cohort B:
- Use of vitamin K antagonists, dabigatran, prothrombin complex concentrates or recombinant factor VII, or transfusion of whole blood or plasma within the preceding 7 days of the index event
- As judged by the investigator, if it is deemed undesirable for the patient to participate in the study or participant is unlikely to comply with study procedures, and requirements
- Involvement in the planning and/or conduct of the study
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT06147830
Principal Investigator
Carolin Dohle, MD
Contact for Study Screening
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Eligibility
- Age 18 years or older
- Unilateral symptomatic stroke due to ischemia or intracerebral hemorrhage. (Note: Bilateral acute stroke is permitted if the stroke that is contralateral to the index stroke is asymptomatic).
- Ischemic stroke cohort will consist of at least 557 participants and intracerebral hemorrhage cohort [exploratory cohort] will consist of up to 100 participants.
- Motor deficits in the acutely affected UE, defined as a Shoulder Abduction and Finger Extension (SAFE) score ≤ 8 out of 10 points20,61 (i.e., excluding full or nearly full motor strength in both shoulder abduction and finger extension) within 48 to 96 hours of stroke onset (or time last known well).
- SAFE score is determined by measuring the strength of shoulder abduction and finger extension, separately, each having a Medical Research Council grade from 0 to 5, then summing; scores range from 0 to 10.
- Provision of signed and dated informed consent form within 24 to 96 hours of stroke onset, (or time last known well). Note: Participant is considered “enrolled” upon starting TMS (at least one stimulation is delivered) or starting study-specific MRI pulse sequence (at least one MRI beep occurs)
- Stated willingness to comply with all study procedures and availability for the duration of the study, including Day 90 visit which must occur in-person.
- Fluent in English or Spanish
- Exclusion criteria:
- UE injury or conditions on paretic side that limited use prior to the stroke
- Legally blind
- Dense sensory loss on paretic side indicated by a score of 2 on NIHSS sensory item
- Unable to abduct the shoulder or extend the fingers of the non-paretic UE on verbal command
- Isolated cerebellar stroke
- Symptomatic stroke in any location within 30 days prior to index stroke.
- Co-enrollment in a trial of an intervention targeting the incident stroke (acute treatment or rehabilitation/recovery intervention) after baseline assessments for VERIFY are initiated
- Known or expected inability to maintain follow-up with study procedures through 90 days
- Cognitive or communication impairment precluding informed consent by the participant.
- Major medical, neurological, or psychiatric condition that would substantially affect functional status
- Non-cerebrovascular diagnosis associated with unlikely survival at 90 days
- Pregnancy
- Contraindication to noncontrast MRI (certain metallic implants, metallic foreign bodies or severe claustrophobia)
- Contraindication to TMS
- Cardiac pacemaker
- Any electronic devices in the body at or above the level of the seventh cervical vertebra (such as cochlear implant, cortical stimulator, deep brain stimulator, vagus nerve stimulator, cervical spine epidural stimulator, or ventriculoperitoneal shunt)
- Ferromagnetic intracranial metallic implant
- Skull defect related to current stroke
- Seizure after onset of current stroke
- Seizure within the last 12 months while taking anti-epileptic medications
- Previous serious adverse reaction to TMS
- Anticipated inability to perform study procedures within 168 hours of symptom onset
- Unable to perform behavioral assessments within 48-120 hours of symptom onset (or time last known well).
- Unable to receive TMS within 72-168 hours or get MRI within 48-168 hours of symptom onset (or time last known well).
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05338697
Principal Investigator
Kitago Tomoko, MD
Contact for Study Screening
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Eligibility
- Male or Female, 22 to 80 years of age at the time of screening.
- Unruptured wide neck aneurysm requiring endovascular treatment suitable for SEAL™ device and meet the AHA guidelines for management of unruptured aneurysms.
- Ruptured wide neck aneurysm is defined as a patient with CT, MRI, or LP evidence of subarachnoid hemorrhage (SAH) attributed to the index aneurysm within the last 60 days. Ruptured aneurysms may be included according to the following criteria:
- The subject is neurologically stable with no seizure at the onset of the SAH, not requiring EVD placement prior to inclusion.
- Hunt and Hess Scale of 2 or less at the time of treatment.
- mRS of ≤2 prior to presentation or aneurysm rupture (pre-morbid mRS).
- Meet the AHA guidelines for management of ruptured aneurysm.
- The index IA to be treated must include the following features:
- Group A (primary analysis group): The Terminus/bifurcation location:
- 2 mm to 19 mm in equatorial aneurysm width wide neck aneurysm:
- Absolute neck size ≥ 4mm and < 9mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome- to-Neck (DN) ratio 1 to 2
- Saccular morphology
- Located in the anterior or posterior circulation
- Group B (Expanded Indication): The wide neck Sidewall location:
- 2 mm to 19 mm in equatorial aneurysm width wide neck aneurysm:
- Absolute neck size ≥ 4mm and < 9mm AND Dome-to-Neck (DN) ratio ≥1 OR Dome- to-Neck (DN) ratio 1 to 2
- Saccular morphology
- Located in the anterior or posterior circulation
- Group A (primary analysis group): The Terminus/bifurcation location:
- Aneurysm treatment does not require the preplanned use of any additional implanted devices.
- Subject is able to maintain compliance with all aspects of screening, evaluation, treatment, and post-procedure follow-up schedule.
- Baseline pre-procedure mRS of 0-2 for unruptured aneurysm and 0-2 prior to the SAH for the ruptured aneurysms.
- Ability to obtain written informed consent document (ICD) subject or legally authorized representative in SAH subjects prior to the initiation of any study procedures.
- Exclusion criteria:
- Aneurysm features unsuitable for endovascular treatment with an intrasaccular device such as fusiform, dissecting pseudo aneurysm, or mycotic aneurysm.
- Aneurysms smaller than 2 mm and larger than 19 mm in dome width.
- Patients with untreated multiple aneurysms [≥2mm]. Patient with multiple aneurysms, should have the none index aneurysms treated no less than 60 days prior to enrollment in the SEAL™ IT trial, ≤ 7mm, and not treated with flow diverter or stent assisted endovascular therapy.
- Inability to access target aneurysm with microcatheter due to intracranial atherosclerosis, proximal or intracranial vessel tortuosity or poor aneurysm angle take-off.
- Patients with two 360 degrees loops in the carotid or vertebral arteries.
- Presence of vascular disease or other vascular abnormality that could prohibit access to index aneurysm such carotid stenosis or diminished caliber of the target artery.
- Clinical, angiographic, or CT evidence of central nervous system (CNS) arterial vasculitis, Moyamoya disease, intracranial tumor (except small meningioma < 3 cm), or any other intracranial vascular malformations.
- Patients with high risk for recurrent ischemic stroke due to previous history of ischemic stroke symptoms such as TIAs, minor, or major strokes within the past 60 days. Other stroke risk factors such as intracranial stenosis or atrial fibrillation.
- Patients with hemodynamic or medical compromise due to medical comorbidities such as severe unstable congestive heart failure (ejection fraction <30%) or severe chronic obstructive pulmonary disease (COPD) requiring home oxygen.
- Target index aneurysm that has been previously treated and contains devices, implants, or coils that could interfere with correct SEAL™ device placement.
- Subject is pregnant or a lactating female (For females of child-bearing potential, a positive pregnancy test within 7 days of the day of procedure or refusal to use a medically accepted method of birth control for the duration of the study.
- Currently on anticoagulation therapy or has a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05831202
Principal Investigator
Fawaz Al-Mufti, MD
Contact for Study Screening