NCT02378792

Brief Summary

Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2014

Typical duration for early_phase_1

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 12, 2016

Status Verified

April 1, 2016

Enrollment Period

3.2 years

First QC Date

February 27, 2015

Last Update Submit

October 11, 2016

Conditions

Refractory Epilepsy

Keywords

PINS VNS Refractory Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month

    4,8,12,16,20,24 months of stimulation

Secondary Outcomes (5)

  • Changes in seizure frequency from baseline to the seizure count evaluvation period

    4,8,12,16,20,24 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 12,24 months

  • Changes in the Number of Anti-epileptic Drugs Prescribed

    At12,24 months

  • Changes from Basline in the Engel and McHugh description

    At 12,24 months

  • Changes from Basline in 24 hour ECG description

    At 12,24 months

Study Arms (2)

Vagus Verve Stimulation is on

EXPERIMENTAL
Device: Vagus Nerve Stimulation

Placebo Vagus Verve Stimulation is off

SHAM COMPARATOR
Device: Vagus Nerve Stimulation

Interventions

Vagus Nerve StimulationDEVICE

Vagus Nerve Stimulator

Also known as: PINS Stimulator System
Placebo Vagus Verve Stimulation is offVagus Verve Stimulation is on

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 6-60.
  • 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 1 seizure per month.
  • In good health except epilepsy.
  • With normal MMSE score
  • Patients or his(her) familyscould 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，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication
  • Alcohol addiction, smoking, and sleep-related breathing disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

The first hospital of jilin university

Changchun, Jilin, 130021, China

RECRUITING

The general of shenyang military

Shenyang, Liaoning, 110011, China

RECRUITING

Qilu hospital of shandong university

Jinan, Shandong, 250012, China

RECRUITING

The second affiliated hospital zhejiang university school of medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

  • Liu H, Zhan P, Meng F, Wang W. Chronic vagus nerve stimulation for drug-resistant epilepsy may influence fasting blood glucose concentration. Biomed Eng Online. 2020 May 29;19(1):40. doi: 10.1186/s12938-020-00784-1.

    PMID: 32471438DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Central Study Contacts

Jia Fumin, PhD

CONTACT

+86 010-59361265pins_medical@163.com

Li Luming, PhD

CONTACT

+86 010-60736388

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 4, 2015

Study Start

August 1, 2014

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

October 12, 2016

Record last verified: 2016-04

Locations

CN(5)