Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
Not Applicable
- Conditions
- Refractory Epilepsy
- Interventions
- Procedure: PINS'Deep Brain Stimulator device
- Registration Number
- NCT02602899
- Lead Sponsor
- Beijing Pins Medical Co., Ltd
- Brief Summary
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PINS Deep Brain Stimulator PINS'Deep Brain Stimulator device Deep Brain Stimulator is on,continuous stimulation to the brain,
- Primary Outcome Measures
Name Time Method Changes in seizure frequency from baseline to the seizure count evaluation period 6 month 6 month of stimulation
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China