Neurostimulation for Dysphagia in Parkinson's Disease

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03253354

Enrollment

Registered

2017-08-17

Start date

2017-08-01

Completion date

2021-08-30

Last updated

2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Diseases, Dysphagia, Parkinson Disease, Swallowing Disorder.Other Specified

Brief summary

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

Detailed description

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.

Interventions

DEVICErepetitive magnetic stimulation

Neurostimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Patient blinding

Intervention model description

4 arm randomised single dose study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Videofluoroscopy	1 hour	Changes in penetration aspiration scale

Secondary

Measure	Time frame	Description
Brain excitability	Immediately after, 30 and 60 minutes	Measures of brain function to single pulse TMS

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026