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Completed

NCT Number: NCT03253354

Neurostimulation for Dysphagia in Parkinson's Disease

This study will explore the effects of 3 different neurostimulation methods on swallowing function in patients with dysphagia secondary to Parkinson's Disease

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Key information

Conditions

Dysphagia Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Otorhinolaryngologic Diseases Parkinson Disease Parkinsonian Disorders Pharyngeal Diseases Swallowing Disorder.Other Specified Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salford Royal Hospital

Salford, Manchester, M6 8HD, United Kingdom

About this study

The aim of this study is to assess 3 novel neuromodulation approaches - namely, pharyngeal stimulation, high frequency (5Hz) repetitive transcranial magnetic stimulation and low frequency (1Hz) repetitive transcranial magnetic stimulation on swallowing function in patients with dysphagia after Parkinson's Disease. A total of 66 patients are planned to be recruited, randomised to one of the 3 technologies or a sham treatment. A single treatment will be given and the effects will be assessed with a barium exam called videofluoroscopy within the 1st hour after the treatment. In addition, some measures of brain function will be recorded, before and after the treatments using single pulse transcranial magnetic stimulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Confirmed Parkinson's Disease with dysphagia

Exclusion criteria

Contraindications to magnetic stimulation, such as pacemakers, significant neuroleptic medications, pregnancy Other causes for dysphagia Unable to give informed written consent

Treatment and study plan

repetitive magnetic stimulation

Device

Neurostimulation

Other names: pharyngeal stimulation

Primary outcomes

  1. Videofluoroscopy

    Time frame: 1 hour

    Changes in penetration aspiration scale

Secondary outcomes

  1. Brain excitability

    Time frame: Immediately after, 30 and 60 minutes

    Measures of brain function to single pulse TMS

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • Northern Care Alliance NHS Foundation Trust

Registry information

Official study title

Exploring Novel Neurostimulation Based Therapies for Swallowing Impairments in Parkinson's Disease

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2017
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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