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Neurology and Neurosurgery: Clinical Research Program

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Neurology and Neurosurgery: Clinical Studies Open For Enrollment

 

 

Clinical Studies Open for Enrollment

 

Embolization of the Middle Meningeal Artery with ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural Hematoma (EMBOLISE)

Eligibility

  • 18 years to 90 years of age
  • Pre-morbid Modified Rankin Score less than or equal to 3
  • Confirmed diagnosis of subacute or chronic subdural hematoma
  • Completed informed consent
  • Meets criteria for Surgery or Observation Cohort

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04402632

Principal Investigator

Justin Santarelli, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

Middle Meningeal Artery EMbolization for the Treatment of SuBduRal HemAtomas with TRUFILL® n-BCA (MEMBRANE)

Eligibility

  • 18 years to 90 years of age
  • Pre-randomization mRS less than or equal to 3
  • Confirmed diagnosis of chronic subdural hematoma
  • Completed informed consent

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04816591

Principal Investigator

Fawaz Al-Mufti, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

A Prospective, Multi-Center, Single Arm Study to Obtain "Real World" Clinical Data and Characterize the Acute and Long-Term Performance of the Micrusframe and Galaxy Coils Including the Pulserider Aneurysm Neck Reconstruction Device for the Endovascular Treatment of Intracranial Aneurysms (STERLING)

Eligibility

  • Patient is between 21 and 80 years of age
  • Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
  • Patient is able and willing to comply with protocol and follow-up requirements

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT03642639

Principal Investigator

Fawaz Al-Mufti, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

Eligibility

  • Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles
  • Willing and able to provide informed consent and to participate in all evaluations

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04427384

Principal Investigator

Simon Hanft, MD

Contact for Study Screening

Monique.Carrero-Tagle@wmchealth.org

A Prospective Non-Invasive Study of Cerebral Blood Flow Velocity Morphology for Quantification of Intracranial Pressure (ICP)

Eligibility

  • Subject is between 18-80 years of age
  • Subject with diagnosis of Traumatic Brain Injury (TBI) or Stroke (i.e. Hemorrhagic Stroke)
  • Subject with invasive ICP monitor (ventriculostomy, or other)
  • Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.

Enrollment Status: Actively enrolling

Study Information

NovaSignal.com

Principal Investigator

Fawaz Al-Mufti, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms using WAVE™ Extra Soft coils, a part of the Penumbra SMART COIL® System (SURF)

Eligibility

  • Patient is at least 18 years of age
  • Patient having embolization of intracranial aneurysms
  • WAVE Extra Soft Coil is final finishing coil
  • Penumbra SMART COIL System accounts for at least 75% of total number of coils implanted
  • Informed consent obtained per IRB/EC requirements

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT04106583

Principal Investigator

Chirag Gandhi, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT 2)

Eligibility

  • Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
  • NIH Stroke Scale Score (NIHSS) equal to or greater than 6
  • Last known well to groin puncture or medical management between 0 - 24 hours
  • Pre-stroke modified Rankin Scale score (mRS) of 0-1
  • Eligible for thrombectomy or medical management
  • Signed Informed Consent obtained
  • Subject willing to comply with the protocol follow-up requirements
  • Anticipated life expectancy of at least three months

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT03876457

Principal Investigator

Chirag Gandhi, MD

Contact for Study Screening

Cristina.Falo@wmchealth.org

 

 

Pediatric 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

 

An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO® with Open-Label Safety Period in Pediatric Subjects with Epilepsy 

Eligibility

  • Patient is between two to five years of age
  • Clinical diagnosis of epilepsy
  • Partial or generalized epilepsy with motor seizures or seizures with clear alteration of awareness for which rescue medications are used at least once a month for the last three months

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05076838

Principal Investigator

Steven Wolf, MD

Contact for Study Screening

ppena_ar@nymc.edu

dzogejan@nymc.edu