Clinical Trials

Our team is currently enrolling participants for:

NeuroPace Responsive Neurostimulator System (RNSTM) NeuroPace
IRB# PN106007
Primary investigator, Dr. Gregory Bergey, 410.955.7338

The NeuroPace Responsive Neurostimulator System (RNSTM) is an investigational medical device. The RNSTM is limited by federal law to investigational use. The safety and efficacy of the RNSTM have not been demonstrated. Strip or depth leads are placed via an open craniotomy of the brain. The device is nested in the bony structure behind the patient’s ear and connected to the strips or depths. The device is programmed to monitor electrical activity in the brain where the leads are placed and to emit an electrical response to decrease detected Epileptiform activity.

Inclusion Criteria:

• Aged 18-65
• 4 seizures per month
• Focal Epilepsy (1 or 2 foci)
• Localizable seizure focus
• 2 or more medications tried
• VNS has to be turned off, no surgeries in the past 6 months
• Are able to complete a seizure diary
• Probably should live locally, lots of visits

Exclusion Criteria:

• Vagal Nerve Stimulator (not turned off)
• Other medical conditions that would preclude surgery
• Pseudoseizures
• Severe Depression

Atkins Diet Protocol
Adult IRB# 04-02-27-08
Pediatric IRB# 05-01-26-05
Primary investigator, Dr. Eric Kossoff, 410.614.6054

This trial is now in the research phase for teens and adults. The investigators use the Atkins diet to induce benign dietary ketosis and monitor the effect of the Atkins diet on seizure control. Children as young as 8 years of age can participate.

Inclusion Criteria:

• 1 or more seizure(s) per week (any type)
• 2 or more medications tried
• Can't have kidney, heart or cholesterol disease
• Can't have major psychiatric disorders
• Can't have tried ketogenic diet in the past year
• Willing to make 4 trips over a 6-month period
• Labs, clinic visits and dietitian are free (for adult patients)

SP 754 (lacosamide - formerly called harkoseride )
WIRB# 20040117
Primary investigator, Dr. Gregory Krauss, 410.955.2822

Study Design:
A multicenter, double-blind, randomized, placebo-controlled, parallel group trial to investigate the efficacy and safety of SPM 927 (400 mg/day, and 600 mg/day) as adjunctive therapy in subjects with partial seizures with or without secondary generalization.

Study Population:
20 patients with complex partial seizures

Major Inclusion Criteria:

• Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures with or without secondary generalization.
• Patient must have had partial onset sz. for at least the last 2 years despite prior therapy with at least 2 AEDs.
• Patient must have been observed to have at least 4 partial onset seizures per 28 days on the average with seizure-free phase no longer than 21 days in 8-week period prior to entry into Baseline Phase.
• Stable dosage regimen of a maximum of 3 AEDs, with or without additional concurrent stable VNS. VNS must have been in place for at least 6 months.
• Dosages of AEDs and VNS must be kept constant for a period of at least 4 weeks prior to entry into Baseline phase.

Major Exclusion Criteria:

• Subject has abnormal ALT, AST, alkaline phosphatase, or total bilirubin level greater than or equal to 2 times the upper limit of normal.
• Subject with impaired renal function, ie, creatinine clearance is lower than 50mL/min at Visit 1.
• Subject with seizures that are uncountable due to clustering.
• Subject with concomitant treatment of felbamate or previous felbamate therapy within the last six months prior to trial entry.
• Subject with concomitant treatment of vigabatrin. Subjects with previous vigabatrin therapy must have had a visual field test (perimetry) prior to trial entry.
• Subject taking one of the following medications influencing the central nervous system within four weeks prior to trial entry: Neuroleptics, MAO inhibitors, tricyclic antidepressants, anxiolytics, amphetamines, sedative antihistamines, tranquilizers, hypnotics, narcotic analgesics, except for medication taken as epileptic treatment
• Subject has confirmed clinically significant abnormality in ECG.

Efficacy of levetiracetam for language dysfunction associated with benign epilepsy with centrotemporal spikes (benign rolandic epilepsy) (BRE)
IRB# 05-02-18-06
Primary investigator, Dr. Eric Kossoff, 410.614.6054

This study investigates the Leviteracetam’s efficacy in treating language dysfunction associated with benign rolandic epilepsy.

Inclusion Criteria:

• Ages 6-12 years
• Have benign rolandic epilepsy
• Currently on another drug for seizures (besides Leviteracitam)
• Current language problems
• Normal hearing
• Will need to come for 3 visits over a 3 month period of time
• Study visits, EEG’s and medications are free