Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-11-30
2028-11-30
Brief Summary
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Detailed Description
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This study aims to investigate the treatment efficacy of TI deep brain stimulation by including drug-resistant patients aged 6-60. During and after TI stimulation, clinical and electrophysiology data will be recorded. Clinical, imaging and electrophysiology data will be analyzed and processed to advance the treatment of drug-resistant epilepsy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Temporal Interference
The investigators perform temporal interference (TI) stimulation to patients with drug-resistant epilepsy. They observe clinical manifestations before, during, and after stimulation to investigate the efficiency of TI.
Temporal Interference
Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of drug resistant epilepsy patients.
Interventions
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Temporal Interference
Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of drug resistant epilepsy patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be clinically evaluated as having drug resistant epilepsy.
* Persistence of disabling seizures at least 2 times per months or greater.
* Informed consent signed.
Exclusion Criteria
* 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.
6 Years
60 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Liankun_Ren
Professor
Principal Investigators
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Liankun Ren, MD
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-316-002
Identifier Type: -
Identifier Source: org_study_id