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Exploratory Study on the Safety and Efficacy of Non-invasive Transcranial Temporal Interference Electrical Stimulation in Improving Epilepsy and related Cognitive Impairment

Exploratory Study on the Safety and Efficacy of Non-invasive Transcranial Temporal Interference Electrical Stimulation in Improving Epilepsy-Related Cognitive Impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102528
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Epilepsy and related Cognitive Impairment

Interventions

Intervention group:Single-session stimulation parameters: frequencies: f1 = 2 kHz, f2= 2.005 kHz
current intensity: 2 mA (within the safe range for human application)
Duration: 30 minutes. Continuous stimulation protocol: consistent with single-session stimulation (f1 = 2 kHz, f2= 2.005 kHz
current intensity: 2 mA
Duration: 30 minutes), once daily, 14 consecutive days.

Sponsors

The second affiliated hospital of Army medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis meeting the criteria for drug-resistant epilepsy (DRE). 2. Age between 18–60 years, with no gender restrictions. 3. Cognitive impairment defined by the Addenbrooke’s Cognitive Examination-III (ACE-III): 1–9 years of education: Score 16 years of education: Score < 80; Intact communication ability (verbal/written). 4. No history of traumatic brain injury or other severe neurological disorders (except epilepsy). 5. No prior neuromodulation therapy (e.g., TI-TES, tDCS, rTMS). 6. Written informed consent obtained after full disclosure of alternative treatments and potential risks.

Exclusion criteria

Exclusion criteria: 1. Presence of psychiatric, cognitive, or psychological disorders that impair the ability to provide informed consent or comply with testing procedures. 2. Patients with secondary epilepsy due to cerebrovascular disease, tumors, infections, or autoimmune disorders. 3. Medication use: Current use of drugs that may alter central nervous system (CNS) function. 4. Skin conditions: Active skin infections, wounds, or lesions at the neurostimulation device contact sites. 5. Substance dependence: History of drug abuse or alcohol dependence.

Design outcomes

Primary

MeasureTime frame
Change in SEEG, ACE-III cognitive assessment scores of epilepsy patients on stimulation day compared to baseline (pre-stimulation);

Secondary

MeasureTime frame
Changes in SEEG, ACE-III scores of epilepsy patients at one month after two-week continuous stimulation compared to baselineChanges in ACE-III scores of epilepsy patients at one month after two-week continuous stimulation compared to baseline;Changes in reaction time and accuracy rate on memory and decision-making paradigm tests in epilepsy patients on stimulation day compared to baseline;Changes in SEEG, ACE-III scores, reaction time and accuracy rate on memory and decision-making paradigm tests in epilepsy patients at one month after two-week continuous stimulation compared to baseline;

Countries

China

Contacts

Public ContactZhang Chun-Qing

The second affiliated hospital of Army medical university

cqzhang@tmmu.edu.cn+86 189 8320 4130

Outcome results

None listed

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