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Exploratory study on the low-intensity transcranial focused ultrasound stimulation for tuberous sclerosis complex-related refractory epilepsy.

Exploratory study on the low-intensity transcranial focused ultrasound stimulation for tuberous sclerosis complex-related refractory epilepsy.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077707
Enrollment
Unknown
Registered
2023-11-16
Start date
2023-11-30
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

tuberous sclerosis complex

Interventions

Center group:The patient will undergo a course of low-intensity transcranial focused ultrasound treatment. The course consists of continuous treatment for 14 days, with each treatment session lasting
Center and perituberal tissue group:The patient will undergo a course of low-intensity transcranial focused ultrasound treatment. The course consists of continuous treatment for 14 days, with each tre

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for TSC (clinical and/or genetic) revised by the International TSC Alliance in 2012; (2) Meet the diagnostic criteria for refractory epilepsy: after regular treatment with two or more anti-epileptic drugs, the frequency of seizures is still not completely controlled; (3) Good compliance of subjects, able to cooperate to complete treatment and follow-up requirements; (4) The subject and their family members agree to participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with severe systemic diseases such as heart, brain, liver, kidney, blood, autoimmune diseases, chronic severe infections, etc.; (2) Contraindication to magnetic resonance imaging (MRI) (presence of metal implants in the body); (3) Currently participating in other interventional clinical trials; (4) Other reasons that the researcher considers inappropriate for inclusion.

Design outcomes

Primary

MeasureTime frame
Frequency of seizures;

Secondary

MeasureTime frame
Cognitive outcomes;Anxiety and depression;Epileptic EEG signals;

Countries

China

Contacts

Public ContactLei Chen

West China Hospital, Sichuan University

leilei_25@126.com+86 189 8060 5819

Outcome results

None listed

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