Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy

NCT06248333 | Recruiting DMC

• 1 other identifier: 2023-174-002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of subthalamic nucleus (STN) as adjunctive therapy for reducing the frequency of seizures in drug-resistant focal motor epilepsy.

Conditions

Epilepsy, Drug Resistant

Keywords

Deep Brain Stimulation; Drug Resistant Epilepsy; Subthalamic Nucleus; Focal Motor Epilepsy

Outcome Measures

Primary Outcomes (1)

• Median Percent Change in Seizure Frequency

  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.

  Through the end of the three-month blinded phase

Secondary Outcomes (13)

• Seizure Responder Rate

  Through the end of the three-month blinded phase

• Seizure Severity

  Through the end of the three-month blinded phase

• Seizure-free Days

  Through the end of the three-month blinded phase

• The maximum length of seizure-free Intervals

  Through the end of the three-month blinded phase

• Life quality evaluation

  Through the end of the three-month blinded phase

Study Arms (2)

Active Stimulation

EXPERIMENTAL

After randomization, participants will undergo STN-DBS ON in the 3-month blinded phase (Month 2 to Month 5) with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.

Device: STN-DBS ON

Sham Stimulation

SHAM COMPARATOR

After randomization, participants will undergo STN-DBS OFF in the 3-month blinded phase (Month 2 to Month 5) with 0mA current, then the stimulator will be turned on with individual stimulation parameters and left on for the remainder of the study.

Device: STN-DBS OFF

Interventions

STN-DBS ON DEVICE

Stimulation ON

Active Stimulation

STN-DBS OFF DEVICE

Stimulation OFF

Sham Stimulation

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age, inclusive, at Screening Visit.
• Refractory to anti-seizure medications (ASMs).
• Diagnosed with focal motor epilepsy, which meets the following items:
• Seizure mainly presents as focal tonic, myoclonic, or primary motor seizure (including primary sensory seizure), with or without secondary bilateral tonic-clonic seizure.
• After a comprehensive evaluation, the epileptogenic zone was presumed to predominantly involve the unilateral or bilateral central area (precentral gyrus, postcentral gyrus, and paracentral lobule) or supplementary motor area according to comprehensive presurgical evaluation.
• Within 1 month prior to the Screening Visit (M-3), the following conditions are met:
• At least 3 focal onset seizures (with or without secondary bilateral tonic-clonic seizure).
• Subject is receiving at least one type of ASM\[s\], and the regimen has been stable (no addition or removal of ASM\[s\] \[not counting brief rescue medicines such as benzodiazepines\]; dose adjustments are permitted to ASM\[s\]).
• Within the baseline period (3 months after the Screening Visit \[M-3\]), the following conditions are met:
• The patient or their caregiver is capable of completing the seizure diary.
• Seizure diary shows an average of 3 or more partial-onset seizures (with or without secondary bilateral tonic-clonic seizure) per month during the Baseline Period, with no more than 30 days between seizures.
• The regimen of ASM\[s\] has been stable (no addition or removal of ASM\[s\] \[not counting brief rescue medicines such as benzodiazepines\]; dose adjustments are permitted to ASM\[s\]).
• After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.
• Informed consent signed.

You may not qualify if:

• Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
• Seizures mainly present as complex motor seizures (e.g., hyperkinetic, automatisms, etc.);
• Tonic-clonic status epilepticus within12 months;
• Psychogenic non-epileptic seizures within 12 months;
• Structural lesion of the subthalamic nucleus;
• Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
• Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
• IQ \< 55 or severe cognitive dysfunction, unable to complete the study;
• Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
• Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
• Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
• Pregnant, or planning to pregnant within 2 years;
• Participation in another clinical study within 3 months;
• Not suitable for enrollment as assessed by the multidisciplinary team of the center.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Beijing Tiantan Hospital: collaborator
• Beijing Sanbo Brain Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Peking University: collaborator

Study Sites (1)

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy, Partial, Motor

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsies, Partial

Study Officials

• Liankun Ren, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren, MD

CONTACT

+86 13681576621; renlk2022@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One day before the first programming, the grouper and the programmer will release the cover independently. Only the grouper and the programmer will know the group information of each patient, in which the programmer does not communicate with the patient about the programming parameters. After each programming, the results are uniformly placed in the programmer to keep the others (patients, neurologists) blind about grouping and parameters. The evaluation will be finished by neurologists, who do not participate in the surgical treatment and programmer. So that the participants, care providers, investigators, and outcomes assessors will not know which group are assigned to from randomization (Month 2) to Month 5. The statistical team is independent of other researchers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: After completion of DBS surgery (Month 0), participants will undergo an 8-day parameter exploration period after 1-month postoperative recovery (month 1), and DBS off after individual parameters have been determined. At Month 2, participants will be randomly assigned to one of two groups: Group A or Group B. Group A (Activate Stimulation) will have their stimulator turned on after randomization. Group B (Sham Stimulation) will receive sham stimulation, meaning the stimulator will remain off until Study Month 5. At Month 5, Group A will continue to receive stimulation and not have the stimulator turned off, and the stimulator in Group B will be turned on and left on for the remainder of the study (Month 11).

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 8, 2024
• Study Start: February 14, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)