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This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporal Interference | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporal Interference | Other | Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of drug resistant epilepsy patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 TI stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Responder Rate | The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency. | Up to 1 year after TI stimulation |
| Life quality evaluation | Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. The minimum and maximum values, and whether higher scores mean a better or worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liankun Ren, MD | Contact | +86 13681576621 | renlk2022@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Liankun Ren, MD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Up to 1 year after TI stimulation |
| Cognitive function evaluation (MMSE) | Percentage change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE score ranges from 0 to 30, with higher scores representing better cognitive function and lower scores indicating greater cognitive impairment. | Up to 1 year after TI stimulation |
| Cognitive function evaluation (MoCA) | Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score. The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores suggesting greater cognitive impairment. | Up to 1 year after TI stimulation |
| Adverse Events | Rate of adverse events which were judged to be study-related throughout the study. | Up to 1 year after TI stimulation |
| Incidence of Sudden Unexpected Death in Epilepsy (SUDEP) | The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up. | Up to 1 year after TI stimulation |