Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
ANT-DBS-RE
1 other identifier
interventional
30
1 country
1
Brief Summary
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 12, 2016
October 1, 2016
2.5 years
October 10, 2015
December 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
6 month of stimulation
Secondary Outcomes (4)
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
Study Arms (1)
PINS Deep Brain Stimulator
EXPERIMENTALDeep Brain Stimulator is on,continuous stimulation to the brain,
Interventions
deep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Pins Medical Co., Ltdlead
- Beijing Tiantan Hospitalcollaborator
Study Sites (1)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luming Li
study principal investigator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2015
First Posted
November 11, 2015
Study Start
April 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
December 12, 2016
Record last verified: 2016-10