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The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Thalamic Ventral Intermediate as adjunctive therapy for alleviating symptoms in refractory familial cortical myoclonus with epilepsy.
This project aims to include 5 participants, and evaluate the effectiveness and safety of Thalamic Ventral Intermediate electrical stimulation in patients with refractory familial cortical myoclonus with epilepsy through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with refractory familial cortical myoclonus with epilepsy with alternative treatment options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thalamic Ventral Intermediate-DBS group | Experimental | Participants will undergo Thalamic Ventral Intermediate-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalamic Ventral Intermediate-DBS | Procedure | Participants will undergo Thalamic Ventral Intermediate-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Tremors | A difference in tremor severity before and after treatment according to the TETRAS scale has been observed. | Up to 3 months after Thalamic Ventral Intermediate-DBS |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Responder Rate | The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency. | Up to 3 months after Thalamic Ventral Intermediate-DBS |
| Life quality evaluation | Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. The minimum and maximum values, and whether higher scores mean a better or worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Rate of adverse events which were judged to be study-related throughout the study. | Up to 3 months after Thalamic Ventral Intermediate-DBS |
| Serious Adverse Event | Rate of serious adverse events which were judged to be study-related throughout the study. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liankun Ren | Contact | 13681576621 | renlk2022@outlook.com |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Up to 3 months after Thalamic Ventral Intermediate-DBS |
| Up to 3 months after Thalamic Ventral Intermediate-DBS |
| Incidence of Sudden Unexpected Death in Epilepsy (SUDEP) | The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up. | Up to 3 months after Thalamic Ventral Intermediate-DBS |