NCT01569503

Brief Summary

The purpose of this study is to determine whether (VNS) Vagus Nerve Stimulation , is effective in the treatment of Crohn's disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
Last Updated

May 3, 2018

Status Verified

August 1, 2017

Enrollment Period

5.1 years

First QC Date

March 30, 2012

Last Update Submit

May 2, 2018

Conditions

Crohn's Disease

Keywords

Crohn's DiseaseVNSvagus nerve stimulationinflammationInflammatory bowel diseasesTNF

Outcome Measures

Primary Outcomes (1)

  • Clinical remission 12 months after initiation of VNS

    Clinical remission at 12 months : 1. Patient without corticoids or a dose of 20mg without dose adjustment (stable treatment) and without anti-TNF, 2. CDAI \<150 or CDAI has dropped by at least 70 or 100 points (Δ70, Δ100) compared with the baseline CDAI 3. Stable immunosuppressive therapy.

    12 months after initiation of VNS

Secondary Outcomes (6)

  • Clinical remission 6 months after initiation of VNS

    6 months after initiation of VNS

  • VNS tolerance

    12 months

  • Assessment of VNS effectiveness with biological markers

    12 months

  • Endoscopic and ultrasound Assessment of VNS effectiveness

    12 months

  • Assessment of the central effects of VNS

    At 6 weeks, at 6 months, at 12 months

  • +1 more secondary outcomes

Study Arms (1)

VSN

EXPERIMENTAL

VNS therapy

Device: vagus nerve stimulation (VNS)

Interventions

vagus nerve stimulation (VNS)DEVICE

VNS therapy consists of an implanted pacemaker-like device that delivers mild, intermittently pulsed signals to the patient's left vagus nerve. Roughly the size of a small pocket-watch and weighing less than one ounce, the pulse generator is implanted in the patient's left chest area. A thin thread-like wire, attached to the generator, runs under the skin to the left vagus nerve in the neck

VSN

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CD involving the ileo-colon, diagnosed for at least 3 months prior to screening in flare (220\<CDAI\<450) of their disease despite a treatment reference (corticosteroids and/or immunosuppressives) with a stable dose will be included
  • CRP\>5mg/l and/or fecal calprotectin \<100µg/l
  • CDEIS \> 7 (Crohn's disease endoscopic index of severity)
  • Consenting patient

You may not qualify if:

  • Known cardiac pathology
  • VNS contraindication
  • Anoperineal CD only or associated with ileocolic lesion
  • Diagnosis of indeterminate colitis, positive stool culture for enteric pathogens
  • CD Surgery within 3 months before screening
  • Short small intestine (\<1m)
  • Koenig syndrome
  • Intra-abdominal abscess
  • Fistula with clinical or radiological abscess evidence
  • Anoperineal CD with or without rectal involvement
  • Ileostomy, colostomy, enteral or parenteral feeding
  • Clinical condition medically or surgically unstable that, at the discretion of the investigator would not be compatible with the patient's participation in the study
  • Any recent neoplasia, in the year prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble university hospital

Grenoble, Isere, 38043, France

Location

Related Publications (2)

  • Meregnani J, Clarencon D, Vivier M, Peinnequin A, Mouret C, Sinniger V, Picq C, Job A, Canini F, Jacquier-Sarlin M, Bonaz B. Anti-inflammatory effect of vagus nerve stimulation in a rat model of inflammatory bowel disease. Auton Neurosci. 2011 Feb 24;160(1-2):82-9. doi: 10.1016/j.autneu.2010.10.007. Epub 2010 Nov 11.

    PMID: 21071287BACKGROUND

  • Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62. doi: 10.1038/35013070.

    PMID: 10839541BACKGROUND

MeSH Terms

Conditions

Crohn DiseaseInflammationInflammatory Bowel Diseases

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Bruno BONAZ, MD, PHD

    Grenoble university hsopital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

March 1, 2012

Primary Completion

March 30, 2017

Study Completion

May 30, 2017

Last Updated

May 3, 2018

Record last verified: 2017-08

Locations

FR(1)