epilepsy
Conditions
Interventions
Experimental group:nucleus accumbens deep brain stimulation
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged 14 to 65 years; 2)Diagnosed as refractory epilepsy (resistant to AED medication for at least 2 years); and considering as the temporal lobe epilepsy after comprehensive presurgical evaluation. 3)With major depression disorder diagnosed according to the Chinese Classification of Mental Disorders version 3 (CCMD-3) and the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV); HAMD-17 score =24, MADRS score =30and unresponsive to multiple antidepressant combinations, psychotherapy and electroconvulsive therapy. 4)At least three disabling seizures (DS), defined as sum of complex partial seizures (CPS) and generalized tonic–clonic seizures (GTCS) per month at baseline. 5)Agree to participate in this study and signed on the informed consent; 6)Comply with the protocol of this study and agree on the follow-up examination as request.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1)Suffer from other psychiatric disorders diagnosed according to DSM-IV, such as schizophrenia, anxiety spectrum disorders, mental retardation, and psychotic disorders caused by psychoactive substances such as alcohol and drugs. 2)Suffer from brain tumors or other degenerative diseases of the central nervous system; 3)There are structural changes in the nucleus accumbens; 4)Severe cognitive dysfunction, IQ<55; 5)Comprehensive or special types of hereditary epilepsy; 6)Women who are pregnant, lactating or planning to become pregnant; 7)Patients with high risk of bleeding; 8)Other severe medical disorders or abnormal liver and kidney function in laboratory tests; 9)Patients who cannot complete the electrical stimulation test due to objective factors, for example, Metal implants, claustrophobia; 10)Abnormal laboratory examinations during the screening period, or other abnormal laboratory examinations considered to be clinically important 11)Participated in other clinical trials within the last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of epilepsy treatment;The score of depression scale(HAMD-17? MADRS) and Anxiety scale(SAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| The severity of seizures;The patient's quality of life(QOLIE-31 scale); | — |
Countries
China
Contacts
Public ContactLiankun Ren
Xuanwu Hospital, Capital Medical University
Outcome results
None listed