TY - JOUR
T1 - A phase 1 open-label trial evaluating focused ultrasound unilateral anterior thalamotomy for focal onset epilepsy
AU - Krishna, Vibhor
AU - Mindel, Jesse
AU - Sammartino, Francesco
AU - Block, Cady
AU - Dwivedi, Alok Kumar
AU - Van Gompel, Jamie J.
AU - Fountain, Nathan
AU - Fisher, Robert
N1 - Publisher Copyright:
© 2023 International League Against Epilepsy.
PY - 2023/4
Y1 - 2023/4
N2 - Objective: Focused ultrasound ablation (FUSA) is an emerging treatment for neurological and psychiatric diseases. We describe the initial experience from a pilot, open-label, single-center clinical trial of unilateral anterior nucleus of the thalamus (ANT) FUSA in patients with treatment-refractory epilepsy. Methods: Two adult subjects with treatment-refractory, focal onset epilepsy were recruited. The subjects received ANT FUSA using the Exablate Neuro (Insightec) system. We determined the safety and feasibility (primary outcomes), and changes in seizure frequency (secondary outcome) at 3, 6, and 12 months. Safety was assessed by the absence of side effects, that is, new onset neurological deficits or performance deterioration on neuropsychological testing. Feasibility was defined as the ability to create a lesion within the anterior nucleus. The monthly seizure frequency was compared between baseline and postthalamotomy. Results: The patients tolerated the procedure well, without neurological deficits or serious adverse events. One patient experienced a decline in verbal fluency, attention/working memory, and immediate verbal memory. Seizure frequency reduced significantly in both patients; one patient was seizure-free at 12 months, and in the second patient, the frequency reduced from 90–100 seizures per month to 3–6 seizures per month. Significance: This is the first known clinical trial to assess the safety, feasibility, and preliminary efficacy of ANT FUSA in adult patients with treatment-refractory focal onset epilepsy.
AB - Objective: Focused ultrasound ablation (FUSA) is an emerging treatment for neurological and psychiatric diseases. We describe the initial experience from a pilot, open-label, single-center clinical trial of unilateral anterior nucleus of the thalamus (ANT) FUSA in patients with treatment-refractory epilepsy. Methods: Two adult subjects with treatment-refractory, focal onset epilepsy were recruited. The subjects received ANT FUSA using the Exablate Neuro (Insightec) system. We determined the safety and feasibility (primary outcomes), and changes in seizure frequency (secondary outcome) at 3, 6, and 12 months. Safety was assessed by the absence of side effects, that is, new onset neurological deficits or performance deterioration on neuropsychological testing. Feasibility was defined as the ability to create a lesion within the anterior nucleus. The monthly seizure frequency was compared between baseline and postthalamotomy. Results: The patients tolerated the procedure well, without neurological deficits or serious adverse events. One patient experienced a decline in verbal fluency, attention/working memory, and immediate verbal memory. Seizure frequency reduced significantly in both patients; one patient was seizure-free at 12 months, and in the second patient, the frequency reduced from 90–100 seizures per month to 3–6 seizures per month. Significance: This is the first known clinical trial to assess the safety, feasibility, and preliminary efficacy of ANT FUSA in adult patients with treatment-refractory focal onset epilepsy.
KW - anterior nucleus
KW - clinical trial
KW - epilepsy
KW - focused ultrasound
KW - thalamotomy
UR - http://www.scopus.com/inward/record.url?scp=85150212091&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85150212091&partnerID=8YFLogxK
U2 - 10.1111/epi.17535
DO - 10.1111/epi.17535
M3 - Article
C2 - 36745000
AN - SCOPUS:85150212091
SN - 0013-9580
VL - 64
SP - 831
EP - 842
JO - Epilepsia
JF - Epilepsia
IS - 4
ER -