Chewing Efficiency Measured by a Two Colour Chewing Gum Test in Amyotrophic Lateral Sclerosis (ALS) Patients?

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Genton Graf Laurence, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01772888
First received: January 17, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.


Condition
Amyotrophic Lateral Sclerosis 11

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chewing Efficiency Measured by a Two Colour Chewing Gum Test: a Marker of Insufficient Nutritional Intakes and Percutaneous Gastrostomy (PEG) Necessity in ALS Patients?

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • - Chewing efficiency [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lip force [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Bite force [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Calorie and protein intakes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Saliva volume [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with ALS
All subjects aged > 18 years, diagnosed with an ALS and included in the multidisciplinary follow-up of the HUG at time of diagnosis will be considered and included, if possible, at their first visit.
Healthy age and gender-matched subjects
Controls matched for age and gender and dental status and without a medical history for neurological or otolaryngologic disease (1 control for 1 patient). They will be recruited among hospital staff and patients of the dental school.

Detailed Description:

Study center: University Hospitals of Geneva Study type: Cohort study with matched controls Study population: 25 ALS patients included in the multidisciplinary cohort study of the University Hospital Geneva between October 2012 and October 2014 and followed for 3 years maximum and 25 controls, matched for age, sex and dental status.

Study duration: Inclusion from October 2012 to October 2014. Follow-up for 3 years.

Study hypothesis: Chewing efficiency, maximum bite and lip force decrease with time in ALS patients and may be a marker of texture adaptation and PEG necessity.

Study aims: The primary aim is to determine whether chewing efficiency, determined by a two-colour mixing ability test, and maximum bite and lip force decrease in ALS patients.

The secondary aims are to determine, in ALS patients, whether:

  • Maximum bite and lip force decrease.
  • Chewing efficiency, maximum bite and lip force decrease more in ALS patients with bulbar than with spinal onset.
  • Chewing efficiency and bite force correlate with energy intakes, nasofibroscopic assessment, and a validated swallowing questionnaire.
  • Saliva volume increases with time and progression of disease and influences masticatory efficiency.
  • Saliva volume is associated with nasofibroscopy assessment.

Methods : Every three months, we will perform:

  • As part of the ongoing cohort study (already accepted by the Ethical Committee) calculation of energy intakes through a 24h recall, nasofibroscopy, swallowing questionnaire and score of disease severity.
  • As part of this study: assessment of dental status at first visit, chewing efficiency test by a with a colour mixing ability test, maximum voluntary bite and lip force, saliva volume and calculation of a 3-day dietary recall instead of a 24h recall.

Statistics: Evolutions with time and between groups, of chewing efficiency, bite and lip force will be assessed by repeated measures ANOVA. Correlations between two continuous variables will be examined by Spearman's correlation coefficients at the different time points. Correlations between a continuous variable and a binary variable (nasofibroscopic assessment) will be explored by logistic regression with mixed effect model.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

ALS patients participating in the cohort study of the University Hospital Geneva

Criteria

Inclusion Criteria:

  • ALS patients
  • > 18 years
  • Participation in the cohort study

Exclusion Criteria:

  • Refusal of participating in the cohort study
  • Presence of PEG
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772888

Contacts
Contact: Laurence Genton, MD +41223729344
Contact: Claude Pichard, MD PhD

Locations
Switzerland
University Hospital Recruiting
Geneva, Switzerland, 1211
Contact: Laurence Genton, MD         
Principal Investigator: Laurence Genton, MD         
Sub-Investigator: Valérie Viatte         
Sub-Investigator: Véronique Karsegard         
Sub-Investigator: Claude Pichard, MD PhD         
Sub-Investigator: Dimitrios Samaras, MD         
Sub-Investigator: Schimmel Martin, MD         
Sub-Investigator: Frauke Müller, MD         
Sub-Investigator: Anne-Chantal Héritier, MD         
Sub-Investigator: Ruxandra Iancu Ferfoglia, MD         
Sub-Investigator: Jean-Paul Janssens, MD         
Sub-Investigator: Igor Leuchter, MD         
Sub-Investigator: Dan Adler, MD         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Laurence Genton, MD University Hospital, Geneva
  More Information

Publications:
Responsible Party: Genton Graf Laurence, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01772888     History of Changes
Other Study ID Numbers: 12-103
Study First Received: January 17, 2013
Last Updated: March 10, 2014
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014