- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07790224
Multi-Parameter Temporal Interference Stimulation in Patients With Epilepsy Undergoing SEEG Monitoring
24. august 2026 oppdatert av: Jian Zhou, Beijing Sanbo Brain Hospital
A Stereoelectroencephalography-Based Study of Brain Functional Modulation by Multi-Parameter Temporal Interference Stimulation in Patients With Epilepsy
This prospective exploratory interventional study aims to investigate the neurophysiological effects and safety of multi-parameter temporal interference (TI) stimulation in patients undergoing stereoelectroencephalography (SEEG) monitoring.
Participants who have already undergone SEEG electrode implantation for clinical indications will receive non-invasive TI stimulation targeting selected deep brain regions according to their individual electrode coverage and neuroimaging data.
Multiple stimulation frequencies will be tested while intracranial SEEG signals are recorded before, during, and after stimulation.
The study will characterize frequency-dependent changes in local and distributed brain activity and explore the relationship between TI stimulation parameters and neurophysiological responses, providing in vivo evidence for parameter optimization of non-invasive deep brain stimulation.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jian Zhou
- Telefonnummer: +86(10)85130669
- E-post: zhoujian5151@163.com
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100018
- Beijing Sanbo Brain Hospital
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Ta kontakt med:
- Jian Zhou
- Telefonnummer: +86(10)85130669
- E-post: zhoujian5151@163.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Aged 18 to 70 years, inclusive, with no restriction on sex.
- Has undergone stereoelectroencephalography (SEEG) electrode implantation, with electrode contacts covering the target deep brain region(s), such as the thalamus, hippocampus, amygdala, or cingulate cortex.
- Is in the postoperative SEEG monitoring period, is clinically stable, and is able to comply with the study procedures.
- The participant or the participant's legally authorized representative is able to fully understand the purpose and procedures of the study and voluntarily provides written informed consent.
Exclusion Criteria:
- Contraindications to magnetic resonance imaging (MRI), such as incompatible metallic implants or a cardiac pacemaker.
- Psychiatric disorders or severe cognitive impairment.
- Structural brain abnormalities, such as cerebral infarction, hydrocephalus, or severe thalamic atrophy.
- Other severe neurological disorders that may interfere with participation in the study.
- Medical or psychiatric contraindications, including recent myocardial infarction, cardiac arrhythmia, stroke, autonomic dysfunction, endocrine disorders, uncontrolled or difficult-to-control hypertension or hypotension, deep brain stimulation for other reasons, degenerative central nervous system disorders, or severe electrolyte disturbances.
- Pregnancy or breastfeeding.
- Participation in another drug or medical device clinical study within 3 months before screening.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Multi-Parameter Temporal Interference Stimulation
Participants will receive multi-parameter temporal interference (TI) stimulation targeting one or two individualized deep brain regions selected according to SEEG electrode coverage and neuroimaging data.
For each target, multiple stimulation frequencies will be administered in a randomized within-participant sequence, with SEEG activity recorded before, during, and after each stimulation condition.
Repeated stimulation sequences and cortical-cortical evoked potential measurements will be performed to characterize the reproducibility and neurophysiological effects of TI stimulation.
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Participants will receive individualized temporal interference (TI) stimulation targeting one or two deep brain regions selected according to SEEG electrode coverage and individual neuroimaging data.
Scalp electrode placement and stimulation intensity will be optimized using individualized finite-element modeling.
Multiple beat-frequency conditions corresponding to delta, theta, alpha, beta, gamma, and high-gamma frequency ranges will be administered in randomized order.
SEEG activity will be recorded before, during, and after stimulation.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change From Pre-stimulation Baseline in SEEG Power Spectral Density
Tidsramme: On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before each TI stimulation condition, during the 90-second stimulation period, and immediately after completion of the stimulation condition.
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On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before each TI stimulation condition, during the 90-second stimulation period, and immediately after completion of the stimulation condition.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in Cortical-Cortical Evoked Potential (CCEP) Amplitude Following TI Stimulation
Tidsramme: On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before and immediately after each 90-second TI stimulation condition.
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On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before and immediately after each 90-second TI stimulation condition.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. august 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
14. august 2026
Først innsendt som oppfylte QC-kriteriene
24. august 2026
Først lagt ut (Faktiske)
27. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SBNK-YJ-2026-013-02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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