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Not yet recruiting NCT06593444

Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy

No phase Interventional Epilepsy (treatment Refractory)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thalamic Ventral Intermediate-DBS.
Who it may be relevant to
Registry conditions: Epilepsy (treatment Refractory). Basic parameters: 30 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Efficacy and Safety of Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy: a Prospective, Pilot Trial

Overview

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.

Interventions

  • Procedure Thalamic Ventral Intermediate-DBS
    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.

Primary outcome measures

  • Severity of Tremors [Time frame: Up to 3 months after Thalamic Ventral Intermediate-DBS]
Secondary outcome measures (2)
  • Seizure Responder Rate [Time frame: Up to 3 months after Thalamic Ventral Intermediate-DBS]
  • Life quality evaluation [Time frame: Up to 3 months after Thalamic Ventral Intermediate-DBS]

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\' 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 \< 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06593444 · 2024-213-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗