Neurostimulation for Dysphagia in Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: repetitive magnetic stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 arm randomised single dose study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharyngeal stimulation<br>Pharyngeal stimulation given at 5Hz for 10 minutes | Device: repetitive magnetic stimulation<br>* Neurostimulation<br>* Other names: pharyngeal stimulation;|
| Active Comparator: repetitive magnetic stimulation (1Hz)<br>repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses | Device: repetitive magnetic stimulation<br>* Neurostimulation<br>* Other names: pharyngeal stimulation;|
| Active Comparator: repetitive magnetic stimulation (5Hz)<br>repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses | Device: repetitive magnetic stimulation<br>* Neurostimulation<br>* Other names: pharyngeal stimulation;|
| Sham Comparator: Sham treatment<br>Sham repetitive transcranial magnetic stimulation using the coil tilt technique | Device: repetitive magnetic stimulation<br>* Neurostimulation<br>* Other names: pharyngeal stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Videofluoroscopy | Changes in penetration aspiration scale | 1 hour | 

Secondary Outcome Measures

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