NCT06708143

Brief Summary

This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Nov 2024Nov 2028

First Submitted

Initial submission to the registry

November 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 30, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

4 years

First QC Date

November 23, 2024

Last Update Submit

November 23, 2024

Conditions

Drug Resistant Epilepsy

Keywords

Temporal InterferenceDrug Resistant Epilepsy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Seizure Responder Rate

    Up to 1 year after TI stimulation

  • Life quality evaluation

    Up to 1 year after TI stimulation

  • Cognitive function evaluation (MMSE)

    Up to 1 year after TI stimulation

  • Cognitive function evaluation (MoCA)

    Up to 1 year after TI stimulation

  • Adverse Events

    Up to 1 year after TI stimulation

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: Temporal Interference

Interventions

Temporal InterferenceOTHER

Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of drug resistant epilepsy patients.

Also known as: TI
Temporal Interference

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Liankun Ren, MD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren, MD

CONTACT

+86 13681576621renlk2022@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2024

First Posted

November 27, 2024

Study Start

November 30, 2024

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations

CN(1)