Subacute Effect of Pharyngeal Pharmacological Sensory Stimulation in Elderly Patients With Oropharyngeal Dysphagia

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.

Conditions

• Oropharyngeal Dysphagia
• Dysphagia
• Swallowing Disorder

Interventions

OTHER

Capsaicin 10microM (TRPV1 natural agonist)

10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.

OTHER

Piperine 150microM (TRPV1 & TRPA1 natural agonist)

10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.

OTHER

Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist)

10 mL Cinnamaldehyde 756,6microM + zinc 70microM solution 3 times per day (before each meal) during 14 consecutive days.

OTHER

Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist)

10 mL Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days.

OTHER

Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists)

10 mL Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days.

OTHER

Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)

10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.

Sponsors & Collaborators

• Hospital de Mataró

  lead OTHER

Principal Investigators

• Pere Clavé, PhD · Hospital de Mataró

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-17

Primary Completion

2022-03-27

Completion

2022-03-27

Countries

• Spain

Study Locations