Temporal Interference for Drug Resistant Epilepsy
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: Temporal Interference.
- Who it may be relevant to
- Registry conditions: Drug Resistant Epilepsy. Basic parameters: 6 years — 60 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Noninvasive Temporal Interference Stimulation for the Treatment of Drug Resistant Epilepsy
Overview
This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60.
Detailed description
Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.
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.
Interventions
- Other Temporal Interference
Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of drug resistant epilepsy patients.
Primary outcome measures
- Seizure Frequency (SF28) [Time frame: Up to 1 year after TI stimulation]
Secondary outcome measures (6)
- Seizure Responder Rate [Time frame: Up to 1 year after TI stimulation]
- Life quality evaluation [Time frame: Up to 1 year after TI stimulation]
- Cognitive function evaluation (MMSE) [Time frame: Up to 1 year after TI stimulation]
- Cognitive function evaluation (MoCA) [Time frame: Up to 1 year after TI stimulation]
- Adverse Events [Time frame: Up to 1 year after TI stimulation]
- Incidence of Sudden Unexpected Death in Epilepsy (SUDEP) [Time frame: Up to 1 year after TI stimulation]
Eligibility criteria
Inclusion criteria
- Participants are between the ages of 6 -60 years of age.
- 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
- Psychogenic non-epileptic seizures within 12 months;
- 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.
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
- Treatment
Study locations
China · 1 center
- Xuanwu Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06708143 · 2024-316-002