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

NCT ID: NCT04052178

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-10
• Study Completion Date: 2018-12-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Repetitive transcranial magnetic stimulation (rtMS)

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.

Group Type: ACTIVE_COMPARATOR

rTMS active and sham

Intervention Type: DEVICE

Repetitive transcranial magnetic stimulation of the pharyngeal sensory cortex.

Intrapharyngeal electrical stimulation (PES)

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.

Group Type: ACTIVE_COMPARATOR

PES active and sham

Intervention Type: DEVICE

Intrapharyngeal electrical stimulation with a catheter delivering electrical pulses.

Capsaicin

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

Group Type: ACTIVE_COMPARATOR

Capsaicin active and placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

rTMS active and sham

Repetitive transcranial magnetic stimulation of the pharyngeal sensory cortex.

Intervention Type: DEVICE

PES active and sham

Intrapharyngeal electrical stimulation with a catheter delivering electrical pulses.

Intervention Type: DEVICE

Capsaicin active and placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Repetitive transcranial magnetic stimulation; Intrapharyngeal electrical stimulation; TRPV1 agonist (capsaicin at 10-5M) or placebo

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Participate or have participated in another clinical interventionist trial in the 4 weeks prior to inclusion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Mataró

OTHER

Sponsor Role: lead

Responsible Party

Pere Clave

Academic Director of Research and Development of the Hospital de Mataró

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pere Clavé, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Mataró

Other Identifiers

FIS2014

Identifier Type: -

Identifier Source: org_study_id