Status:

COMPLETED

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

Lead Sponsor:

Hospital de Mataró

Conditions:

Swallowing Disorder

Dysphagia

Eligibility:

All Genders

18+ years

Phase:

NA

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 neurophysi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 10 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 21 2018

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT04052178

Start Date

February 10 2016

End Date

December 21 2018

Last Update

August 13 2019

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