Neurostimulation for Dysphagia in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease; Swallowing Disorder.Other Specified; Dysphagia; Brain Diseases
• Interventions: Device: repetitive magnetic stimulation

• Registration Number: NCT03253354
• Lead Sponsor: University of Manchester

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-17
• Primary Completion: 2021-04-30
• Study Completion: 2021-08-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
repetitive magnetic stimulation (5Hz)	repetitive magnetic stimulation	repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses
Sham treatment	repetitive magnetic stimulation	Sham repetitive transcranial magnetic stimulation using the coil tilt technique
repetitive magnetic stimulation (1Hz)	repetitive magnetic stimulation	repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses
Pharyngeal stimulation	repetitive magnetic stimulation	Pharyngeal stimulation given at 5Hz for 10 minutes

Primary Outcome Measures

Name	Time	Method
Videofluoroscopy	1 hour	Changes in penetration aspiration scale

Secondary Outcome Measures

Name	Time	Method
Brain excitability	Immediately after, 30 and 60 minutes	Measures of brain function to single pulse TMS

Trial Locations

Locations (1)

Salford Royal Hospital; 🇬🇧 Salford, Manchester, United Kingdom