Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Raktažodžiai
Santrauka
apibūdinimas
The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for necrotization or coagulation of epileptogenic foci in patients with intractable mesial temporal lobe epilepsy.
The study will include approximately 150 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events, and neuropsychological outcomes.
Datos
| Paskutinį kartą patikrinta: | 10/31/2019 |
| Pirmasis pateikimas: | 07/14/2016 |
| Numatytas registravimas pateiktas: | 07/20/2016 |
| Pirmas paskelbtas: | 07/25/2016 |
| Paskutinis atnaujinimas pateiktas: | 11/19/2019 |
| Paskutinis atnaujinimas paskelbtas: | 11/21/2019 |
| Faktinė studijų pradžios data: | 11/30/2016 |
| Numatoma pirminio užbaigimo data: | 04/30/2022 |
| Numatoma studijų užbaigimo data: | 04/30/2022 |
Būklė ar liga
Intervencija / gydymas
Device: Treatment
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: Treatment Visualase MRI-guided laser ablation procedure | Device: Treatment All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - History of drug-resistant mesial temporal lobe epilepsy (MTLE) - If the subject has a vagus nerve stimulator (VNS), must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months - On stable antiepileptic drugs (AEDs) (and/or stable VNS setting, if applicable) and compliant with medication use - An average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month - Seizure symptoms and/or auras compatible with MTLE - Video EEG shows evidence of seizures from one temporal lobe consistent with MTLE - MRI has evidence consistent with mesial temporal lobe sclerosis - Willing and able to remain on stable AEDs (and stable VNS setting, if applicable) for 12 months following the Visualase procedure - Willing and able to comply with protocol requirements - Able to complete study assessments in English or Spanish language Exclusion Criteria: - Unwilling or unable to sign the study informed consent form - Pregnant or intends to become pregnant during the course of the study - Currently implanted with a device contraindicating MRI - Progressive brain lesions and/or tumors not associated with epileptic disease state - History of previous intracranial surgery for treatment of epileptic seizures - Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes on EEG - Seizures with contralateral or extra-temporal ictal onset on EEG - Aura and/or ictal behavior suggest an extra-temporal focus - MRI evidence of epileptogenic, extra-temporal lesions, dual pathology in the temporal lobe, or contralateral hippocampal MRI increased signal and/or loss of architecture - If additional testing has been performed, results are discordant with the seizure focus scheduled for ablation - Non-compliance with AED requirements - IQ < 70 - Dementia or other progressive neurological disease - Unstable major psychiatric illness, psychogenic non-epileptic seizures, or medical illness that would contraindicate the Visualase procedure or affect the neuropsychological assessments - Participation in other research that may potentially interfere with SLATE endpoint(s) - Allergy to gadolinium |
Rezultatas
Pirminės rezultatų priemonės
1. Incidence of qualifying adverse events [12 months]
2. Seizure freedom, defined as Engel Classification of Postoperative Outcome Class I [12 months]
Antrinės rezultatų priemonės
1. Seizure freedom compared to historical controls [12 months]
2. Seizure freedom, including subjects retreated with Visualase [12 months]
3. Change in Boston Naming Test scores [Baseline and 12 months]
4. Change in Rey Auditory Verbal Learning Test scores [Baseline and 12 months]
5. Change in Short Form-36 (SF-36) Health Survey scores [Baseline and 12 months]
6. Change in Quality of Life in Epilepsy (QOLIE-31) scores [Baseline and 12 months]
