Neurostimulation for Dysphagia in Parkinson's Disease

University of Manchester

Status: Completed

Conditions: Dysphagia; Swallowing Disorder.Other Specified; Parkinson Disease; Brain Diseases

Treatments: Device: repetitive magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03253354

IRAS: 200591

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 4 patient groups

Pharyngeal stimulation

Active Comparator group

Description:

Pharyngeal stimulation given at 5Hz for 10 minutes

Treatment:

Device: repetitive magnetic stimulation

repetitive magnetic stimulation (1Hz)

Active Comparator group

Description:

repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses

Treatment:

Device: repetitive magnetic stimulation

repetitive magnetic stimulation (5Hz)

Active Comparator group

Description:

repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses

Treatment:

Device: repetitive magnetic stimulation

Sham treatment

Sham Comparator group

Description:

Sham repetitive transcranial magnetic stimulation using the coil tilt technique

Treatment:

Device: repetitive magnetic stimulation