NCT01726751

Brief Summary

To elucidate Spinal Cord Stimulation (SCS) as treatment for IBS. An SCS system with a 4-polar electrode at the T5-8 level is implanted. In a randomized, cross-over study design, active stimulation is compared to a period without stimulation, with an ensuing tailing stimulation period, twice as long. Patients recorded average pain level, pain attacks, number of diarrheas and global quality of life. At the end of the study patients can choose to retain their SCS stimulation system or have it removed. The outcome of the present trial will show whether SCS is a useful treatment of IBS. The long-term follow-up will show the continuous amelioration of SCS over at least six months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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, 2005

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

8.7 years

First QC Date

October 30, 2012

Last Update Submit

November 5, 2018

Conditions

Irritable Bowel SyndromeConstipationDiarrheaPain

Keywords

Spinal cord stimulationIrritable bowel syndromeAbdominal painDiarrhea

Outcome Measures

Primary Outcomes (1)

  • To investigate if typical abdominal pain of IBS can be ameliorated by SCS?

    During the whole study period each patient will record the number of pain attacks. Patients are scheduled for regular outpatient controls, at 2, 8, 14, 26 and 28 weeks after implantation

    According to protocol for 26 weeks

Secondary Outcomes (1)

  • To record effects of SCS on diarrhea/constipation

    According to protocol for 26 weeks

Other Outcomes (1)

  • To evaluate quality of life and side effects, feasibility and tolerability of SCS, validated as willingness to retain the stimulation equipment.

    According to protocol for 26 weeks

Study Arms (2)

Early off-stimulation (group B)

OTHER

Late SCS treatment. After 2 weeks without SCS, randomization to either of two study arms: Group B starting with no SCS for a period of six weeks (A) followed by a period of active SCS (on-period for 6 weeks). Thereafter, free stimulation for 12 weeks, followed by a concluding 2 sweeks of no SCS.

Device: Spinal Cord Stimultion (SCS)Device: Spinal cord nerve stimulation

Early on-stimulation (group A)

OTHER

Early SCS treatment. After 2 weeks without SCS, randomization to either of two study arms: Group A starting with SCS for a period of six weeks (A) followed by a period of no SCS (off-period for 6 weeks). Thereafter, free stimulation for 12 weeks, followed by a concluding 2 sweeks of no SCS.

Device: Spinal Cord Stimultion (SCS)Device: Spinal cord nerve stimulation

Interventions

Spinal Cord Stimultion (SCS)DEVICE

Electric stimulation of the spinal cord

Also known as: Quad-plus®, Medtronic Inc., MN, USA
Early off-stimulation (group B)Early on-stimulation (group A)
Spinal cord nerve stimulationDEVICE
Early off-stimulation (group B)Early on-stimulation (group A)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-60, Rome II criteria, abdominal pain \>4 (0-10 VAS), stable symptoms for \>2 years

You may not qualify if:

  • other gastrointestinal disease, somatic or psychiatric co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Solna, Stockholm County, 17176, Sweden

Location

Related Publications (1)

  • O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

    PMID: 34854473DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeConstipationDiarrheaPainAbdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Officials

  • Per M Hellström, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Spinal cord stimulation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, senior consultant

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 15, 2012

Study Start

August 1, 2005

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations

SE(1)