NCT00653887

Brief Summary

Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 16, 2012

Status Verified

February 1, 2012

Enrollment Period

1.7 years

First QC Date

April 2, 2008

Last Update Submit

February 14, 2012

Conditions

IncontinenceConstipation

Keywords

Biofeedbackanal sphinctercortical excitabilitymagnetic stimulationincontinenceconstipation

Outcome Measures

Primary Outcomes (1)

  • external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction

    final

Study Arms (2)

A

ACTIVE COMPARATOR

biofeedback (active group)

Other: Biofeedback

B

PLACEBO COMPARATOR

discussion about digestive tract (placebo group)

Other: Placebo

Interventions

BiofeedbackOTHER

4 sessions of biofeedback one session each week

A
PlaceboOTHER

4 sessions, one each week, of discussion about anorectal disease

B

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers between 18 years old and 35 years old
  • Right handed\*

You may not qualify if:

  • Pregnancy
  • Pace-maker or other metallic piece implanted in the body
  • Neurological disease
  • Epilepsy
  • Digestive disease
  • Traumatic delivery
  • Anorectal surgery
  • Biofeedback
  • Psychiatric disease
  • Treatment anti-epileptic, hypnotic, psychotropic
  • Participation to a previous protocol within 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiology Unit - Rouen university Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Constipation

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Anne-Marie LEROI, PhD

    CHU Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 7, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

February 16, 2012

Record last verified: 2012-02

Locations

FR(1)