Biomechanical, Neurophysiological and Clinical Effects of 6-month Stimulation Using TRPV1 and TRPA1 Agonists in Older Patients With Oropharyngeal Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Severity of oropharyngeal dysphagia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The products will be prepared in the Pharmacy Department and will be labeled with a code that does not allow its identification neither by the patient nor by the investigator who administers it.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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
- •Metal in the head
- •Participation in another clinical trial (previous month).
结局指标
主要结局
Severity of oropharyngeal dysphagia
时间窗: 6 month follow-up visit
The severity of oropharyngeal dysphagia will be determined according the penetration-aspiration scale during the videofluoroscopy: 1. Material does not enter the airway. 2. Material enters the airway. Remains above vocal cords and is ejected from the airway. 3. Material is above vocal cords and is not ejected from the airway. 4. Material enters the airway, contacts vocal cords and is ejected from the airway. 5. Material contacts the vocal cords and is not ejected from the airway. 6. Material passes below the vocal cords and is ejected into larynx or out of the airway. 7. Material passes below the vocal cords and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal cords and no effort is made to eject the material
Safety impairment signs
时间窗: 6 month follow-up visit
Prevalence of safety impairment signs (penetrations and/or aspirations) according to videofluoroscopic results
Efficacy impairment signs
时间窗: 6 month follow-up visit
Prevalence of efficacy impairment signs (oral and pharyngeal residue) according to videofluoroscopic results
Swallow biomechanics
时间窗: 6 month follow-up visit
Measurement of the timing of oropharyngeal swallow response during the videofluoroscopy: * Time to laryngeal vestibule closure * Time to upper esophageal sphincter opening * Time to laryngeal vestibule opening
Pharyngeal motor evoked potentials (pMEP)
时间窗: 6 month follow-up visit
pMEPs for both brain hemispheres will be recorded with an intra-pharyngeal catheter by applying 10 pulses of transcraneal magnetic stimulus to each hotspot (tenar and pharyngeal).
Pharyngeal sensory evoked potential (pSEP)
时间窗: 6 month follow-up visit
pSEP will be recorded with a 32-electrode EEG recording cap (10/20 system) during a series of electrical stimuli applied to the pharynx with an intra-pharyngeal catheter.
次要结局
- Clinical outcomes: Prevalence of lower respiratory tract infections(Pre treatment visit and 1, 3 and 6 month follow-up visits)
- Clinical outcomes: Mortality(Pre treatment visit and 1, 3 and 6 month follow-up visits)
- Treatment palatability: Texture(1, 3 and 6 month follow-up visits)
- Treatment safety(From the inclusion to the study until the end of their participation (6 month))
- Spontaneous swallowing frequency (SSF)(Pre treatment visit and 1, 3 and 6 month follow-up visits)
- Clinical outcomes: Hospital readmission rate(Pre treatment visit and 1, 3 and 6 month follow-up visits)
- Responders rate(6 month follow-up visit)
- Treatment palatability: Taste(1, 3 and 6 month follow-up visits)
- Salivary neuropeptides(1, 3 and 6 month follow-up visits)
- Treatment palatability: Future Adherence(1, 3 and 6 month follow-up visits)
- Treatment compliance(Pre treatment visit and 1, 3 and 6 month follow-up visits)
研究者
Pere Clave
Principal Investigator
Hospital de Mataró