Clinical trial NCT05958173: Effects of 6-month of Treatment With TRPV1 and TRPA1 Agonists in Older Patients With OD
Official title: Biomechanical, Neurophysiological and Clinical Effects of 6-month Stimulation Using TRPV1 and TRPA1 Agonists in Older Patients With Oropharyngeal Dysphagia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oropharyngeal Dysphagia
Swallowing Disorder
Keywords: TRP agonists
Sensory stimulation
Rehabilitation
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, double-blinded, three-arm randomized clinical trial
Primary purpose: TREATMENT

Brief summary: In recent years, the investigators have characterized the impairments in pharyngeal sensory function associated with swallowing disorders in older patients with oropharyngeal dysphagia (OD). The investigators have demonstrated the acute and sub-acute therapeutic effect of TRP agonists on mechanical and neural swallow responses in patients with OD. The present hypothesis is that 6-months treatment with TRPV1 (capsaicin) or TRPA1 (piperine) agonists will improve the biomechanics and neurophysiology of the swallow response without inducing desensitization. The aim of this study is to evaluate the effect on biomechanics assessed by videofluoroscopy (VFS), neurophysiology (pharyngeal evoked sensory potentials -pSEP- and motor evoked potentials -pMEP-), and clinical outcomes during a 6-month treatment with TRP agonists added to the alimentary bolus 3 times a day in older patients with OD. Design: 150 older patients (\>70y) with OD will be included in a randomized clinical trial with three treatment arms, in which the effect of oral administration of 1) capsaicin 10µM (TRPV1 agonist), 2) piperine 150µM (TRPA1), and 3) placebo (Control), will be evaluated. Measurements: 1) VFS signs of swallowing safety and efficacy and timing of swallow response ; 2) Spontaneous swallowing frequency; 3) Latency, amplitude and cortical representation of pSEP and pMEP; 4) Concentration of substance P and CGRP in saliva, 5) Clinical outcomes (respiratory and nutritional complications). The results of this study will increase evidence for a new generation of pharmacological treatments for older patients with OD, moving from compensation to rehabilitation of the swallowing function.


Eligibility criteria: Inclusion Criteria:

* ≥70 years
* With a positive Volume-Viscosity Swallow Test for oropharyngeal dysphagia
* Penetration-aspiration scale \>1 in videofluoroscopy
* Able to follow the protocol and to give written informed consent.

Exclusion Criteria:

* Life expectancy \< 3m or palliative care
* Allergy to iodinated contrast or to the components of the treatment solutions
* Cancer or active infection
* Implanted electronic device
* Epilepsy
* Metal in the head
* Participation in another clinical trial (previous month).

Primary outcomes:
measure: Severity of oropharyngeal dysphagia
timeFrame: Pre treatment visit
measure: Severity of oropharyngeal dysphagia
timeFrame: 1 month follow-up visit
measure: Severity of oropharyngeal dysphagia
timeFrame: 3 month follow-up visit
measure: Severity of oropharyngeal dysphagia
timeFrame: 6 month follow-up visit
measure: Safety impairment signs
timeFrame: Pre treatment visit
measure: Safety impairment signs
timeFrame: 1 month follow-up visit
measure: Safety impairment signs
timeFrame: 3 month follow-up visit
measure: Safety impairment signs
timeFrame: 6 month follow-up visit
measure: Efficacy impairment signs
timeFrame: Pre treatment visit
measure: Efficacy impairment signs
timeFrame: 1 month follow-up visit
measure: Efficacy impairment signs
timeFrame: 3 month follow-up visit
measure: Efficacy impairment signs
timeFrame: 6 month follow-up visit
measure: Swallow biomechanics
timeFrame: Pre treatment visit
measure: Swallow biomechanics
timeFrame: 1 month follow-up visit
measure: Swallow biomechanics
timeFrame: 3 month follow-up visit
measure: Swallow biomechanics
timeFrame: 6 month follow-up visit
measure: Pharyngeal sensory evoked potential (pSEP)
timeFrame: Pre treatment visit
measure: Pharyngeal sensory evoked potential (pSEP)
timeFrame: 1 month follow-up visit
measure: Pharyngeal sensory evoked potential (pSEP)
timeFrame: 3 month follow-up visit
measure: Pharyngeal sensory evoked potential (pSEP)
timeFrame: 6 month follow-up visit
measure: Pharyngeal motor evoked potentials (pMEP)
timeFrame: Pre treatment visit
measure: Pharyngeal motor evoked potentials (pMEP)
timeFrame: 1 month follow-up visit
measure: Pharyngeal motor evoked potentials (pMEP)
timeFrame: 3 month follow-up visit
measure: Pharyngeal motor evoked potentials (pMEP)
timeFrame: 6 month follow-up visit
Secondary outcomes:
measure: Spontaneous swallowing frequency (SSF)
timeFrame: Pre treatment visit and 1, 3 and 6 month follow-up visits
measure: Clinical outcomes: Hospital readmission rate
timeFrame: Pre treatment visit and 1, 3 and 6 month follow-up visits
measure: Clinical outcomes: Prevalence of lower respiratory tract infections
timeFrame: Pre treatment visit and 1, 3 and 6 month follow-up visits
measure: Clinical outcomes: Mortality
timeFrame: Pre treatment visit and 1, 3 and 6 month follow-up visits
measure: Responders rate
timeFrame: 6 month follow-up visit
measure: Treatment palatability: Taste
timeFrame: 1, 3 and 6 month follow-up visits
measure: Treatment palatability: Texture
timeFrame: 1, 3 and 6 month follow-up visits
measure: Treatment palatability: Future Adherence
timeFrame: 1, 3 and 6 month follow-up visits
measure: Salivary neuropeptides
timeFrame: 1, 3 and 6 month follow-up visits
measure: Treatment safety
timeFrame: From the inclusion to the study until the end of their participation (6 month)
measure: Treatment compliance
timeFrame: Pre treatment visit and 1, 3 and 6 month follow-up visits
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
Study officials:
References: