Refractory Epilepsy
Conditions
Keywords
PINS, Deep Brain Stimulator, Refractory Epilepsy, Anterior Thalamic Nucleus
Brief summary
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.
Interventions
PROCEDUREPINS'Deep Brain Stimulator device
deep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time
Sponsors
Beijing Tiantan Hospital
Beijing Pins Medical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* age 12-60. * having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose. * at least 6 seizures per month. * in good health except epilepsy. * to with normal MMSE score * patients or his(her) familys could understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up
Exclusion criteria
* results of MRI remind epilepsy caused by intracranial space-occupying lesions. * the vagus nerve lesion and damage * tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in seizure frequency from baseline to the seizure count evaluation period 6 month | 6 month of stimulation |
Secondary
| Measure | Time frame |
|---|---|
| Changes in seizure frequency from baseline to the seizure count evaluation period | 1,3,6,12 months of stimulation |
| Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment | Mean change from baseline QOLIE-31 Overall Score at 1,3,6,12 months |
| Change in the Number of Anti-epileptic Drugs Prescribed | At 1,3,6,12 months |
| Change from Baseline in the Engel and McHugh description | At 1,3,6,12 months |
Countries
China
Contacts
Primary ContactFumin Jia
Backup ContactLuming Li
Outcome results
None listed