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Epilepsy Research

Cell transplantation for epilepsy: A First-in-human (FIH), Multicenter, Open Label, Single Arm, Dose Escalation Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)

Multicenter trial (Sponsor: Neurona)

Purpose: Neurona Therapeutics is studying an investigational drug (NRTX-1001) as a possible treatment for drug-resistant Mesial Temporal Lobe Epilepsy. NRTX-1001 is a cell product that will be placed surgically into the brain area that originates seizures. UTHealth Houston will serve as a center for the trial.

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Network based neuro-modulation for mesial temporal lobe epilepsy

Investigator: Nitin Tandon, MD

Purpose: Current stimulation treatment for MTLE involves the implantation of a recording/stimulation device with 2 electrodes placed bilaterally in the anterior nucleus of the thalamus (ANT), and the delivery of high-frequency stimulation to disrupt the epilepsy network. In this grant, we will implant two devices in each patient, which will give us 4 electrodes to implant in 4 different areas of the MTLE network. We will see if stimulating these different locations with low-frequency stimulation will produce greater seizure reduction.

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RNS System NAUTILUS Study (NAUTILUS)

Multicenter trial (Sponsor: NeuroPace)

Purpose: Researchers at UTHealth Houston are enrolling patients with drug-resistant idiopathic generalized epilepsy (IGE) in a multi-institutional trial evaluating the safety and effectiveness of thalamic stimulation with the NeuroPace RNS® System as an adjunctive treatment to reduce the frequency of primary generalized seizures.

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Autonomic and Imaging Biomarkers of Sudden Unexpected Death in Epilepsy (SUDEP). The Center For SUDEP Research (CSR), including the CSR Administrative and Informatics Cores

Investigator: Samden Lhatoo

Lead RC: Jaison Hampson

Key Inclusion Criteria: Diagnosis of epilepsy ages ≥ 1yr children and adults

Enrollment Status: Actively enrolling Clinical Trials.gov NCT # not required

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Study of Cerebrovascular Reactivity (CVR) to Hypercapnia using Blood Oxygenation Level-Dependent (BOLD) Magnetic Resonance Imaging (MRI).

Investigator: Samden Lhatoo

Lead RC: Sandhya Rani

Purpose: To study the relationship between Hypercapnic Ventilatory Response (HCVR), Respiratory depression and Sudden Unexpected Death in Epilepsy (SUDEP).

Key Inclusion Criteria: 18-60 yr old Healthy volunteers vs dx Epilepsy. (Respiratory or cardiac limitations to breathing are excluded)

Enrollment Status: Actively enrolling

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Occult Epileptic Seizures and Epileptiform Activity in Patients with Alzheimer’s Disease: A Prospective Study Using a Computer-Based Detector, High-Density Electroencephalography, and Magnetoencephalography

Investigator: Samden Lhatoo

Lead RC: Manuela Ochoa

Key Inclusion Criteria: AD, Dementia, or presymptomatic AD. ( Atypical course or etiologically mixed presentation excluded)

Enrollment Status: Actively enrolling

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Comprehensive EEG Database for Study of Definite, Probable and Possible Seizure Disorders

Investigator: Samden Lhatoo

Lead RC: Shirin Omadi

Purpose: Comprehensive database

Key Inclusion Criteria: Chart review only. All pts referred for EEG evaluation

Enrollment Status: Chart review only. Not enrolling.

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Human Autonomic and Respiratory Responses to Direct Cortical Stimulation

Investigator: Samden Lhatoo

Lead RC: Laura Vilella

Purpose: To study human autonomic and respiratory responses to direct cortical stimulation

Key Inclusion Criteria: 18 yrs and up with DX of epilepsy admitted to EMU for Intracranial video EEG eval

Enrollment Status: Actively enrolling.

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Outcome of epilepsy surgery in patients with refractory epilepsy and developmental cortical malformations

Investigator: Samden Lhatoo

Lead RC: Shirin Omadi

Key Inclusion Criteria: All patients with refractory epilepsy who have developmental cortical malformations.

Enrollment Status: Chart review only. Not enrolling.

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Genetics in epilepsy

Investigator: Samden Lhatoo

Lead RC: Shirin Omadi

Key Inclusion Criteria: All patients who have an established diagnosis of epilepsy. Seen at UTPB/Hermann plaza epilepsy or epilepsy surgery clinics or admitted in the EMU of Memorial Hermann Hospital

Enrollment Status: Actively enrolling

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Comparative study of Postictal generalized electroencephalographic (EEG) suppression (PGES) in surface EEG (sEEG) and intracranial EEG (iEEG)

Investigator: Samden Lhatoo

Lead RC: Shirin Omadi

Key Inclusion Criteria: Age ≥ 18 years with medical refractory epilepsy who undergo intra-cranial monitoring in the Adult EMU. (Patients with intra-cranial EEG monitoring who did not have at least one generalized tonic-clonic seizure during monitoring are excluded)

Enrollment Status: Actively enrolling

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Computational Ethnography Using Activity Logs from EpiToMe. Assessment of workflow, behavior and optimal EHR use

Investigator: Samden Lhatoo

Lead RC: Shiqiang Tao/Jaison Hampson

Key Inclusion Criteria: Review of activity logs (retrospective and prospective), Clinicians using EpiToMe

Enrollment Status: Actively Enrolling

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Analysis of multimodal sensor data and algorithms with a wearable device in patients undergoing epilepsy treatment

Investigator: Samden Lhatoo

Lead RC: Jaison Hampson

Key Inclusion Criteria: 18-80 yrs undergoing epilepsy treatment willing to wear device

Enrollment Status: Actively enrolling

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Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE)

Investigator: Nitin Tandon, MD

Lead RC: Jessica Johnson, NP

Purpose: The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).

Key Inclusion Criteria: history of drug resistant MTLE, on stable AEDS and Stable VNS setting (if applicable), on avg of at least 1 complex partial or secondary generalized SZ compatible with MTLE per month. If the subject has a VNS, must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months

Enrollment Status: Actively enrolling

Clinical Trials.gov NCT # https://clinicaltrials.gov/show/NCT02844465

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RNS® System Post-Approval Study in Epilepsy

Investigator: Nitin Tandon, MD

Lead RC: Connie Okon

Purpose: Observational study designed to assess the long-term safety and effectiveness of the RNS System as an adjunctive therapy in reducing the frequency of seizures.

Key Inclusion Criteria: Clinical decision to treat the patient with the RNS system. in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizure.

Enrollment Status: actively enrolling

Clinical Trials.gov NCT # https://clinicaltrials.gov/show/NCT02403843

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