An Open-Label, Parallel, Randomized Study to Evaluate the Performance of Needle Placements for Diagnostic and Therapeutic Neuraxial Procedures, Using a Handheld Tactile Imaging-based Method Versus Palpation

Date Added
April 27th, 2021
PRO Number
Pro00109240
Researcher
Jonathan Halford

List of Studies


Keywords
Spinal Cord, Surgery
Summary

The purpose of this study is to test a new device called VerTouch. This is a handheld device that is designed to help the doctor perform the LP. LP is a Lumbar Puncture and is also known as a spinal tap. It is a medical procedure in which a needle is inserted into the spinal canal, most commonly to collect cerebrospinal fluid for diagnostic testing. The main reason for a lumbar puncture is to help diagnose diseases of the central nervous system, including the brain and spine. An EAI is an epidural anesthesia procedure that delivers medicines that numb parts of your body to block pain. They are given through shots in or around the spine.The regular way to perform the LP and EAI procedure is for the doctor to feel the patient's back with their hands to find the location of the bones of the spine, and then insert a needle between the spinal bones into the body area near the theca sac (for the EAI procedure) or into the thecal sac, where the spinal fluid is (for the LP procedure). The Vertouch device has an electronic system which feels the pressure of the skin around the back, and shows the doctor a picture of where the bones of the spine may be. This may help the doctor insert the needle between the bones more accurately. The device just creates an image of the underlying structure; it does not guide the user to any particular spot within that image (beyond the user being instructed to pick the lowest pressure area between SPs, to put it simply). So the device itself does not do any decision-making in regard to how the procedure is performed.

The purpose of this study is to measure if the Vertouch device helps the doctor perform the LP and EAI procedures more quickly and accurately. This study plans to include approximately 96 patients at 3 different hospital, with 32 of those patients being at MUSC.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
bulgarino@musc.edu

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus

Date Added
February 23rd, 2021
PRO Number
Pro00107718
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This is a research study to evaluate a medication for the treatment of status epilepticus. Status epilepticus is a condition when a patient has continuous seizure activity which usually causes them to be unconscous, be very confused and sometimes to have abnormal body movements. Sometime status epilepticus will not stop after treatment with medications which are currently used by doctors. New medications to stop status epilepticus are needed. This is a study of a medication called ganalaxone which would be administered intravenously to patients with status epilepticus after two typical medications have been tried and not worked. This is a placebo controlled study, meaning that some of the patients will be randomly selected to receive the study medication and some will be selected to receive the placebo medication (which in this case is just salt water given intravenously). Patients in the study will be monitored using continuous electroencephalography (EEG) monitoring and physical exams to determine if the status epilepticus stops. Patients will be called several weeks after treatment to see how well they are doing.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
bulgarino@musc.edu

A 57-WEEK, MULTICENTER, ACTIVE-TREATMENT, OPEN-LABEL EXTENSION TRIAL OF CVL-865 AS ADJUNCTIVE THERAPY IN ADULTS WITH DRUG-RESISTANT FOCAL ONSET SEIZURES

Date Added
February 9th, 2021
PRO Number
Pro00106750
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This 57-week, active-treatment, open-label (all participants will receive study drug throughout the study) extension trial ( enrolls participants of a previous clinical trial into another study) in which all participants gets the study drug is designed to assess the safety and tolerability of CVL-865 as adjunctive treatment (another treatment used together with the primary treatment) in subjects with drug-resistant focal onset seizures. This trial is open to subjects who completed treatment with the investigational medicinal product (IMP) in the double-blind (neither the participant or researchers know what study drug they are receiving) Phase 2 Trial CVL-865-SZ-001 and who, in the opinion of the investigator, could potentially benefit from treatment with CVL-865. There are 17 visits for a duration of 57 active-treatment weeks. The visits are approximately one month apart.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
bulgarino@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Trial of CVL-865 as Adjunctive Therapy in Adults with Drug-Resistant Focal Onset Seizures (REALIZE Trial)

Date Added
March 10th, 2020
PRO Number
Pro00096604
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

The purpose of this study is to find out if a drug called CVL-865 is safe and effective in the treatment for focal onset epilepsy. The study has an 8-week screening period, followed by a treatment period where adults 18 - 75 years of age that qualify for treatment will be randomly assigned to 3 different dose levels of the study drug. This is followed by a 4-week safety follow up period. The study will last approximately 25 weeks with approximately 7 research related clinic appointments. Participants that successfully complete the treatment period will also have the option of participating in a separate open-label extension study and all participants will be taking the study drug.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
Bulgarino@musc.edu



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