Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia.

NCT04052178 | Completed

• 1 other identifier: FIS2014
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study design: Multicenter, experimental, randomized, crossed, double blind study (patient and results analysis). Aim: To evaluate the effect of different neurostimulation techniques on the neurophysiological and biomechanical swallowing mechanisms of patients with dysphagia associated with chronic stroke and select those techniques with the best results to be evaluated in the second phase of the study (medium-term effects). Outcome measures:

• Videofluoroscopy: prevalence of impaired efficacy and safety of swallow (penetrations and aspirations), penetration aspiration scale (PAS: from 0 to 8), biomechanical parameters (time to laryngeal vestibule closure, upper esophageal sphincter opening).
• Pharyngeal sensory evoked potentials (pSEP): latency and amplitude of obtained evoked potentials. Higher latency (0 onwards) means worse outcome and higher amplitude (0 onwards) means better outcome.
• Pharyngeal motor evoked potentials (pMEP): latency, amplitude, duration and area of obtained evoked potentials. Higher latency (0 onwards) means worse outcome and higher amplitude (0 onwards) means better outcome. Treatments and patients: 36 post-stroke patients with oropharyngeal dysphagia (PAS superior or equal to 2) randomized patients in 3 treatment arms (3 groups of 12 patients).
• Active and sham repetitive transcranial magnetic stimulation (rTMS): 90% of the resting motor threshold, 1250 pulses, 5 Hz.
• Active and sham Intrapharyngeal Electrical Stimulation (PES): 75% of tolerance threshold, pulses of 0.2 ms, 5 Hz, 10 min.
• Oral Capsaicin (active intervention, 10-5M, TRPV1 agonist) and placebo solution (sham): 100 mL, single administration. Administration of study therapies: The study will be performed in two visits separated for one week. In each visit patients will randomly receive active or sham treatment and a pre-post evaluation of biomechanics of deglutition (with VFS) and neurophysiological mechanisms (swallowing afferent and efferent pathways) will be performed in each visit. Acute randomized administration -\> 1 active session (pre/post evaluation with VFS/pSEP/pMEP) + 1 separate control session 1 week apart (pre/post evaluation with VFS/pSEP/pMEP).

Conditions

Swallowing Disorder; Dysphagia; Stroke; Neurophysiologic Abnormality

Keywords

Oropharyngeal dysphagia; Stroke; Sensory stimulation

Outcome Measures

Primary Outcomes (3)

• Pharyngeal motor evoked potential (pMEP): latency and amplitude

  Study the magnitude of the effect by calculating the change of the evoked potential from baseline immediately after the application of the intervention produced by the different treatments. This will be examined and compared between active and sham intervention.

  The event wil be assessed with pMEP immediately after the application of the intervention (time frame maximum up to 2 hours).

• Pharyngeal sensory evoked potential (pSEP): latency and amplitude

  Study the magnitude of the effect by calculating the change of the evoked potential from baseline immediately after the application of the intervention produced by the different treatments. This will be examined and compared between active and sham intervention.

  The event wil be assessed with pSEPs immediately after the application of the intervention (time frame maximum up to 2 hours).

• Penetration-aspiration scale (PAS) score

  Study the magnitude of the effect by calculating the change on the prevalence of unsafe swallow (PAS≥2) in videofluoroscopy (VFS) from baseline immediately after the application of the intervention. This will be examined and compared between active and sham intervention.

  The event wil be assessed with the PAS score immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

Secondary Outcomes (5)

• Opening and closing time of the laryngeal vestibule

  The event wil be assessed with VFS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

• Prevalence of pharyngeal residue

  The event will be assessed with VFS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

• Resting motor threshold (RMT) of the pharyngeal cortex

  The event wil be assessed with TMS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

• Pharyngeal sensory thresholds

  The event wil be assessed with pharyngeal electrical stimulation immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment).

• Incidence of Treatment-Emergent Adverse Events

  Although its occurrence is early after the TMS session, seizures and other side effects will be monitored up to 3 months after the intervention.

Study Arms (3)

Repetitive transcranial magnetic stimulation (rtMS)

ACTIVE COMPARATOR

Acute repetitive transcranial magnetic stimulation on the pharyngeal sensory cortex. Applied intensity 90% of the resting motor threshold, 1250 pulses at 5 Hz. Each treatment arm was placebo/sham compared with a time separation of one week. The assignment to either active or sham was randomized.

Device: rTMS active and sham

Intrapharyngeal electrical stimulation (PES)

ACTIVE COMPARATOR

Intrapharyngeal electrical stimulation applied to an intensity of 75% of the tolerance threshold with 0.2 ms pulses at 5 Hz during 10 min. Each treatment arm was placebo/sham compared with a time separation of one week. The assignment to either active or sham was randomized.

Device: PES active and sham

Capsaicin

ACTIVE COMPARATOR

100 mL of oral capsaicin solution at a concentration of 10-5M. Each treatment arm was placebo/sham compared with a time separation of one week. The assignment to either active or sham was randomized

Dietary Supplement: Capsaicin active and placebo

Interventions

rTMS active and sham DEVICE

Repetitive transcranial magnetic stimulation of the pharyngeal sensory cortex.

Also known as: Repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rtMS)

PES active and sham DEVICE

Intrapharyngeal electrical stimulation with a catheter delivering electrical pulses.

Also known as: Intrapharyngeal electrical stimulation

Intrapharyngeal electrical stimulation (PES)

Capsaicin active and placebo DIETARY_SUPPLEMENT

Capsaicin solution (TRPV1 agonist) at a concentration of 10-5M or placebo solution.

Also known as: TRPV1 agonist (capsaicin at 10-5M) or placebo

Capsaicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years.
• Patients with a diagnosis of stroke of more than 3 months of evolution.
• Patients with clinical signs of dysphagia according to the volume viscosity swallowing test (V-VST).
• Patients capable of complying with the study protocol.
• Explained study and signed informed consent.

You may not qualify if:

• History of severe neurodegenerative, digestive diseases, epilepsy or previous seizures.
• Pacemaker or implanted defibrillator carriers.
• Implanted electrode carriers or other stimulation systems.
• Implant carriers or metal plates on the head or neck.
• Cochlear implant carriers.
• Medication pump carriers.
• History of hearing loss associated with noise.
• Cardiopulmonary instability.
• Oropharyngeal dysphagia of structural causes.
• History of head and neck surgery.
• Alcohol or drug dependence.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Hospital de Mataró: lead

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Pere Clavé, PhD

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Director of Research and Development of the Hospital de Mataró

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 9, 2019
• Study Start: February 10, 2016
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share