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

NCT06593444 | Not Yet Recruiting DMC

• 1 other identifier: 2024-213-003
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy (treatment Refractory)

Keywords

Deep Brain Stimulation; Thalamic Ventral Intermediate; Refractory Familial Cortical Myoclonus with Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Seizure Responder Rate

  Up to 3 months after Thalamic Ventral Intermediate-DBS

• Life quality evaluation

  Up to 3 months after Thalamic Ventral Intermediate-DBS

Other Outcomes (3)

• Adverse Events

  Up to 3 months after Thalamic Ventral Intermediate-DBS

• Serious Adverse Event

  Up to 3 months after Thalamic Ventral Intermediate-DBS

• Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)

  Up to 3 months after Thalamic Ventral Intermediate-DBS

Study Arms (1)

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.

Procedure: Thalamic Ventral Intermediate-DBS

Interventions

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.

Thalamic Ventral Intermediate-DBS group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with FCMTE whose symptoms are essentially controlled after standardized medication and other treatments.
• Presence of structural abnormalities in the VIM (ventral intermediate nucleus).
• 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.
• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Liankun Ren

CONTACT

13681576621; renlk2022@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: March 20, 2025
• Study Completion: September 20, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share