Trials Sponsors Conditions Drugs Pricing

Conditions

Epilepsy Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis

Keywords

Radio-frequency thermocoagulationStereoelectroencephalographySubiculum

Outcome Measures

Primary Outcomes (1)

Seizure frequency (SF28)
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28.
Up to 1 year after subculum-SEEG Guided RF-TC

Secondary Outcomes (6)

Seizure Responder Rate
Up to 1 year after subculum-SEEG Guided RF-TC
Life quality evaluation
Up to 1 year after subculum-SEEG Guided RF-TC
Cognitive function evaluation (MMSE)
Up to 1 year after subculum-SEEG Guided RF-TC
Cognitive function evaluation (MoCA)
Up to 1 year after subculum-SEEG Guided RF-TC
Adverse Events
Up to 1 year after subculum-SEEG Guided RF-TC
+1 more secondary outcomes

Study Arms (1)

Subiculum RF-TC group

EXPERIMENTAL

SEEG recording and Subiculum RF-TC minimal invasive treatment for mTLE-HS

Procedure: Subiculum RF-TC

Interventions

Subiculum RF-TCProcedure

SEEG implantation after evaluation, record the interictal and ictal EEG, and perform Subiculum RF-TC.

Subiculum RF-TC group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age14 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Participants are between the ages of 14 -65 years of age
Refractory to anti-seizure medications (ASMs).

Sponsors & Collaborators

Xuanwu Hospital, Beijing
Otherlead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

Liankun Ren, MD
Xuanwu Hospital, Beijing
PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren

CONTACT

+86 13681576621 renlk2022@outlook.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 19, 2024

Study Start

August 9, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 20, 2025

Estimated (date passed)

High Selective Subiculum SEEG Guided RF-TC for mTLE-HS

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Subiculum RF-TC group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Subiculum RF-TC group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record