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Long term effects of DBS on ANT in epilepsy patients: A clinical study protocol for multimodal imaging omics and behavioral studies

Long term effects of DBS on ANT in epilepsy patients: A clinical study protocol for multimodal imaging omics and behavioral studies

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080037
Enrollment
Unknown
Registered
2024-01-18
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

epilepsy

Interventions

DBS:DBS therapy

Sponsors

the Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age: The age range of the subjects is 14 to 70 years old. Clinical diagnosis of epilepsy: Participants must be diagnosed with drug-resistant epilepsy. The diagnosis will be based on established diagnostic criteria, such as the International League Against Epilepsy (ILAE) epilepsy classification system. Disease severity: The Global Assessment of Severity of Epilepsy (GASE) Scale4 is used to assess the severity of seizures in subjects using the epilepsy rating scale. Previous treatment: Participants should undergo drug trials, physical therapy, or other standard treatments for epilepsy for at least two years. Recording past treatments can evaluate treatment outcomes and potential impacts on the long-term efficacy of DBS. Preoperative evaluation: including detailed medical history collection, long-term video electroencephalography of 3 or more clinical seizures, epilepsy series MR examination, and PET-MR examination. After multidisciplinary consultation (MDT), it was determined that epilepsy could not be surgically removed, or seizures still occurred after surgical removal. Willingness to undergo DBS surgery: Participants must indicate their willingness to undergo DBS surgery as a treatment option. Informed consent will be obtained to ensure that participants fully understand the risks, benefits, and alternative treatment options associated with DBS. Participants who are unwilling to undergo surgical intervention will be excluded from the study. Other factors: In the selection process, other factors such as overall physical health, cognitive function, and medication history need to be considered to ensure the safety of participants and the universality of research results. These factors will be screened through medical records, physical examinations, cognitive assessments, and interviews.

Exclusion criteria

Exclusion criteria: 1) There is a significant cognitive impairment that can affect the patient's daily living abilities (such as social, work, and medication use). 2) Clearly severe (refractory) mental illnesses such as depression, anxiety, and schizophrenia. 3) Clearly coexisting medical diseases affect surgery or survival.

Design outcomes

Primary

MeasureTime frame
Improvement of epilepsy symptoms;

Secondary

MeasureTime frame
Improvement of cognitive function;Improvement of psychological and mental disorders;

Countries

China

Contacts

Public ContactXiao Qihua

Affiliated Hospital of Xuzhou Medical University

709094385@qq.com+86 180 5226 8701

Outcome results

None listed

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