NCT02428790

Brief Summary

Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied. The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Status
completed

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

First Submitted

Initial submission to the registry

April 17, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

April 17, 2015

Last Update Submit

December 1, 2015

Conditions

Brain InjuryConstipation

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal transit time (GITT) [in days]

    During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.

Secondary Outcomes (1)

  • Association between heart rate variability (HRV) and GITT

    During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.

Study Arms (1)

ABI Patients

Patients with acquired brain injury.

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at Hammel Neurocenter and University Clinic, during rehabilitation after aquired brain injury

You may qualify if:

  • ABI:
  • Moderate to severe traumatic brain injury (TBI) (Glasgow Coma Scale (GCS) score 3-12 at admission)
  • or Stroke
  • or Anoxic brain injury
  • Ability to swallow the capsules used to assess GITT
  • Ability to give meaningful informed consent to participate in the study

You may not qualify if:

  • Major abdominal disorders
  • Severe acute comorbidity
  • Known cancer
  • Pregnancy
  • Known autonomic neuropathy
  • Other known neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain InjuriesConstipation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Henning Andersen, Professor, Dr. med. PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 29, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-01