Clinical trial NCT06593444: Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy
Official title: The Efficacy and Safety of Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy: a Prospective, Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy (treatment Refractory)
Keywords: Deep Brain Stimulation
Thalamic Ventral Intermediate
Refractory Familial Cortical Myoclonus with Epilepsy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 5
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 30-70, meeting the diagnostic criteria for Refractory Familial Cortical Myoclonus with Epilepsy (FCMTE), meaning that tremors and/or seizures have not significantly improved despite long-term, stable use of current treatment medications, regardless of gender.
* Tremors and seizures severely impact the patients\&#39; work and quality of life.
* Experiencing drug resistance or intolerable adverse reactions to medication.
* After being adequately informed about the nature and risks of the study, willing to provide written informed consent before participating in any study-related procedures.
* Willing to adhere to the relevant trial protocol and regulations, including attending follow-up visits and undergoing related examinations within the specified timeframe.

Exclusion Criteria:

* Patients with FCMTE whose symptoms are essentially controlled after standardized medication and other treatments.
* Presence of structural abnormalities in the VIM (ventral intermediate nucleus).
* Presence of an implanted electrical stimulator (e.g., pacemaker, spinal cord stimulator, repetitive nerve stimulator) or metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagus nerve stimulation (with stable parameters for at least 3 months) is not an exclusion criterion.
* IQ \&amp;lt; 55, severe cognitive impairment that prevents participation in the study.
* Pregnant individuals or those planning to conceive within 2 years.
* Presence of progressive neurological diseases such as brain tumors, arteriovenous malformations, or cavernous hemangiomas.
* Presence of other serious neuropsychiatric disorders such as dementia, severe depression (hospitalized in a psychiatric facility within the past 5 years or any suicidal or self-harming tendencies), schizophrenia, or neurodegenerative diseases. Resolved postictal psychiatric or behavioral abnormalities are not an exclusion criterion.
* Conditions that may increase the risk of seizures during or after surgery (e.g., coagulation disorders) or require long-term oral anticoagulants or antiplatelet drugs.
* Other severe physical illnesses, psychiatric disorders, internal diseases, or severe liver or kidney dysfunction; participation in other clinical trials within the past three months.

Primary outcomes:
measure: Severity of Tremors
timeFrame: Up to 3 months after Thalamic Ventral Intermediate-DBS
Secondary outcomes:
measure: Seizure Responder Rate
timeFrame: Up to 3 months after Thalamic Ventral Intermediate-DBS
measure: Life quality evaluation
timeFrame: Up to 3 months after Thalamic Ventral Intermediate-DBS
Other outcomes:
measure: Adverse Events
timeFrame: Up to 3 months after Thalamic Ventral Intermediate-DBS
measure: Serious Adverse Event
timeFrame: Up to 3 months after Thalamic Ventral Intermediate-DBS
measure: Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
timeFrame: Up to 3 months after Thalamic Ventral Intermediate-DBS
Locations:
Study officials:
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