Subacute Effect of Pharyngeal Pharmacological Sensory Stimulation in Elderly Patients With Oropharyngeal Dysphagia
FIS2018
Subacute Effect of Pharmacological Sensory Stimulation of the Oropharynx by Agonists of TRP Receptors in Swallowing Neurophysiology in the Elderly With Oropharyngeal Dysphagia.
1 other identifier
interventional
150
1 country
1
Brief Summary
Oropharyngeal sensory impairments are a potential target for treatment of oropharyngeal dysphagia (OD) in older patients. We previously found acute administration of TRP sensory stimulants improved VFS signs and swallow response. We hypothesized that sub-acute administration of TRP pharyngeal sensory stimulants, would improve cortical neuroplasticity and will lead into a faster and stronger swallow response, however desensitization of TRP receptors may occur. Therefore, the aim of the present study was to assess the biomechanical (Videofluoroscopy) and neurophysiological (pharyngeal sensory evoked potentials -PSEPs- and motor-evoked potentials (MEPs)) effect of 2 week treatment with TRP agonists in older patients with OD. Design: 150 older (\>70yr) patients with OD will be included in a Randomized Control Trial assessing the effect of oral administration of either: a) capsaicin (TRPV1); b) piperine (TRPV1/TRPA1) c) cinnamaldehyde (TRPA1); d) citric acid (ASIC3); e) capsaicin+citric acid (TRPV1/ASIC3); and f) placebo (Control). Measurements: 1) VFS signs of safety and efficacy of swallow and timing and extent of swallow response; 2) Latency, amplitude and cortical representation of PSEP and MEP; 3) Substance P concentration in saliva by ELISA as a marker of peripheral stimulation. Results from this study might help to develop new and effective pharmacological treatments for older dysphagic patients, from compensation to recovery of swallow function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
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 17, 2019
CompletedFirst Submitted
Initial submission to the registry
January 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2022
CompletedJuly 13, 2022
July 1, 2022
3.2 years
January 29, 2021
July 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the score of the Penetration Aspiration Scale
Differences found in the videofluoroscopy Penetration Aspiration Scale (from 1 (safe swallow) to 8 (silent aspiration)) between treatments and vs. the placebo group.
Baseline versus 2/3 days after the intervention
Secondary Outcomes (11)
Impaired safety of swallow
Baseline versus 2/3 days after the intervention
Impaired efficacy
Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (laryngeal vestibule closure time)
Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (upper esophageal opening time)
Baseline versus 2/3 days after the intervention
Oropharyngeal swallow response (laryngeal vestibule opening time)
Baseline versus 2/3 days after the intervention
- +6 more secondary outcomes
Study Arms (6)
Capsaicin 10microM
ACTIVE COMPARATOR10mL capsaicin 10microM solution 3 times/day during 14 consecutive days (2 weeks).
Piperine 150microM
ACTIVE COMPARATOR10mL Piperine 150microM solution 3 times/day during 14 consecutive days (2 weeks).
Cinnamaldehyde 756,6microM + zinc 70microM
ACTIVE COMPARATOR10mL Cinnamaldehyde 756,6microM + zinc 70microM solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks).
Citric acid 457,5microM (pH=3,5)
ACTIVE COMPARATOR10mL Citric acid 457,5microM (pH=3,5) solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks).
Capsaicin 10microM + Citric acid 457,5microM (pH=3,5)
ACTIVE COMPARATOR10mL Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks).
Placebo
PLACEBO COMPARATOR10mL placebo solution 3 times/day during 14 consecutive days (2 weeks).3 times/day during 14 consecutive days (2 weeks).
Interventions
10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.
10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.
10 mL Cinnamaldehyde 756,6microM + zinc 70microM solution 3 times per day (before each meal) during 14 consecutive days.
10 mL Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days.
10 mL Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days.
10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.
Eligibility Criteria
You may qualify if:
- More than 70 years old.
- Oropharyngeal dysphagia with impaired safety of swallow (penetration aspiration score higher or equal than 2).
- Patients able to comply with the study protocol.
- Signature or the written informed consent.
You may not qualify if:
- Previous history of severe gastrointestinal diseases.
- Epilepsy or previous convulsive crisis episodes.
- Pacemaker or implanted defibrillator carriers.
- Cardiopulmonary instability.
- Oropharyngeal dysphagia of structural cause.
- Previous history of head and neck surgery.
- Neurodegenerative disease.
- Advanced dementia (GDS higher than 5).
- Gastroesophageal reflux.
- Taking drugs with effects on dopamine.
- Neoplasia or active infection.
- Alcohol, tobacco or drugs dependence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Consorci Sanitari del Maresme (Hospital de Mataró)
Mataró, Barcelona, 08301, Spain
Related Publications (1)
Guanyabens N, Tomsen N, Palomeras E, Mundet L, Clave P, Ortega O. Neurophysiological characterization of oropharyngeal dysphagia in older patients. Clin Neurophysiol. 2024 Jun;162:129-140. doi: 10.1016/j.clinph.2024.03.030. Epub 2024 Apr 4.
PMID: 38615499DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pere Clavé, PhD
Hospital de Mataró
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 29, 2021
First Posted
February 5, 2021
Study Start
January 17, 2019
Primary Completion
March 27, 2022
Study Completion
March 27, 2022
Last Updated
July 13, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share