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NCT03253354 Clinical Trial

Neurostimulation for Dysphagia in Parkinson's Disease

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03253354
Other study ID # IRAS: 200591
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date August 30, 2021

Study information
Verified date June 2022
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date August 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• repetitive magnetic stimulation
Neurostimulation

Locations
Country Name City State
United Kingdom Salford Royal Hospital Salford Manchester

Sponsors (2)
Lead Sponsor Collaborator
University of Manchester Northern Care Alliance NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Videofluoroscopy Changes in penetration aspiration scale 1 hour
Secondary Brain excitability Measures of brain function to single pulse TMS Immediately after, 30 and 60 minutes
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