Neurology: Clinical Studies Open for Enrollment
Responsive Stimulation for Adolescents with Epilepsy (RESPONSE) Study
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
ppena_ar@nymc.edu
dzogejan@nymc.edu
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
Cristina.Falo@wmchealth.org
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
Cristina.Falo@wmchealth.org