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Exploratory Study on Non-Invasive Transcranial Deep Brain Electrical Stimulation for the Treatment of Drug-Resistant Epilepsy

Exploratory Study on Non-Invasive Transcranial Deep Brain Electrical Stimulation for the Treatment of Drug-Resistant Epilepsy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104506
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-03-18
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

Single group:Different stimulation parameters and targets

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18 and 60 years, regardless of gender; (2) Diagnosed with drug-resistant epilepsy, with focal seizures; drug-resistant epilepsy is defined as failure to achieve sustained seizure freedom after the application of two anti-epileptic drugs (either as monotherapy or in combination); (3) For the stimulation frequency comparison experiment, subjects must have undergone intracranial electrode implantation, with electrode placements including the hippocampus, thalamus, anterior cingulate gyrus, and insula; (4) The patient or their family must fully understand the treatment method, cooperate in completing the clinical trial, and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: (1)Presence of brain tumors or other central neurodegenerative disorders, (2)Significant organic brain alterations (3)Severe cognitive impairment (4)Psychogenic non-epileptic seizures (PNES) (5)Generalized or specific types of hereditary epilepsy (6)Having undergone epilepsy-related surgical interventions within 6 months prior to implantation (7)Women who are lactating or pregnant (8)Participation in other clinical trials within 3 months before screening (9)Pre-existing psychiatric conditions that would preclude required examinations (10)Other severe systemic diseases or clinically significant laboratory abnormalities (e.g., hepatic/renal dysfunction) that may affect follow-up (11)Objective factors preventing completion of follow-up (economic constraints, transportation limitations, etc.) (12)Clinically significant abnormal laboratory findings during screening period (13)Unwillingness to sign informed consent documents

Design outcomes

Primary

MeasureTime frame
Interictal epileptiform discharges and high-frequency oscillations in intracranial EEG recordings before and after each experimental session;

Secondary

MeasureTime frame
Waveform changes in intracranial EEG recordings before and after each experimental session;

Countries

China

Contacts

Public ContactTao Yu

Xuanwu Hospital, Capital Medical University

yutaoly@sina.com+86 133 9176 9290

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026