Deep Brain Stimulation of the Anterior Nucleus of the Tha... | NCT02602899

Studies
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy

NCT02602899

Sponsor

Beijing Pins Medical Co., Ltd

Status

Unknown status

Last Update Posted

Dec 12, 2016Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Refractory Epilepsy

Interventions

PINS'Deep Brain Stimulator device

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Oct 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Oct 10, 2015

First Submission Date that Met QC Criteria

Nov 10, 2015

First Posted Date

Nov 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2016

Last Update Posted Date

Dec 12, 2016Estimated

Name	Class
Beijing Tiantan Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PINS Deep Brain Stimulator	Experimental	Deep Brain Stimulator is on,continuous stimulation to the brain,	Procedure: PINS'Deep Brain Stimulator device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PINS'Deep Brain Stimulator device	Procedure	deep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time	PINS Deep Brain Stimulator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month		6 month of stimulation

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fumin Jia	Contact	+86 010-59361265		pins_medical@163.con
Luming Li	Contact	+86 010-60736388

Overall Officials

Name	Affiliation	Role
Luming Li	study principal investigator	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tiantan Hospital	Recruiting	Beijing	Beijing Municipality	100050	China

Condition Browse Module

MeSH Terms

ID	Term
D000069279	Drug Resistant Epilepsy

Ancestor Terms

ID	Term
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided