Neurostimulation for Dysphagia in Parkinson's Disease

NCT ID: NCT03253354

Last Updated: 2022-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2021-08-30

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.

Conditions

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Dysphagia Parkinson Disease Swallowing Disorder.Other Specified Brain Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 arm randomised single dose study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patient blinding

Study Groups

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Pharyngeal stimulation

Pharyngeal stimulation given at 5Hz for 10 minutes

Group Type ACTIVE_COMPARATOR

repetitive magnetic stimulation

Intervention Type DEVICE

Neurostimulation

repetitive magnetic stimulation (1Hz)

repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses

Group Type ACTIVE_COMPARATOR

repetitive magnetic stimulation

Intervention Type DEVICE

Neurostimulation

repetitive magnetic stimulation (5Hz)

repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses

Group Type ACTIVE_COMPARATOR

repetitive magnetic stimulation

Intervention Type DEVICE

Neurostimulation

Sham treatment

Sham repetitive transcranial magnetic stimulation using the coil tilt technique

Group Type SHAM_COMPARATOR

repetitive magnetic stimulation

Intervention Type DEVICE

Neurostimulation

Interventions

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repetitive magnetic stimulation

Neurostimulation

Intervention Type DEVICE

Other Intervention Names

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pharyngeal stimulation

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Care Alliance NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Prof Shaheen Hamdy PhD FRCP

Professor of Neurogastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaheen Hamdy, PhD FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Salford Royal Hospital

Salford, Manchester, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IRAS: 200591

Identifier Type: -

Identifier Source: org_study_id

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