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Neurostimulation for Dysphagia in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03253354
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Collaborator:
Salford Royal NHS Foundation Trust
Information provided by (Responsible Party):
Prof Shaheen Hamdy PhD FRCP, 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

Condition or disease Intervention/treatment Phase
Dysphagia Parkinson Disease Swallowing Disorder.Other Specified Brain Diseases Device: repetitive magnetic stimulation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 4 arm randomised single dose study
Masking: Single (Participant)
Masking Description: Patient blinding
Primary Purpose: Treatment
Official Title: Exploring Novel Neurostimulation Based Therapies for Swallowing Impairments in Parkinson's Disease
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pharyngeal stimulation
Pharyngeal stimulation given at 5Hz for 10 minutes
Device: repetitive magnetic stimulation
Neurostimulation
Other Name: pharyngeal stimulation

Active Comparator: repetitive magnetic stimulation (1Hz)
repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses
Device: repetitive magnetic stimulation
Neurostimulation
Other Name: pharyngeal stimulation

Active Comparator: repetitive magnetic stimulation (5Hz)
repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses
Device: repetitive magnetic stimulation
Neurostimulation
Other Name: pharyngeal stimulation

Sham Comparator: Sham treatment
Sham repetitive transcranial magnetic stimulation using the coil tilt technique
Device: repetitive magnetic stimulation
Neurostimulation
Other Name: pharyngeal stimulation




Primary Outcome Measures :
  1. Videofluoroscopy [ Time Frame: 1 hour ]
    Changes in penetration aspiration scale


Secondary Outcome Measures :
  1. Brain excitability [ Time Frame: Immediately after, 30 and 60 minutes ]
    Measures of brain function to single pulse TMS



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253354


Contacts
Contact: Emilia Michou, PhD +44 161 2064363 emilia.michou@manchester.ac.uk
Contact: Shaheen Hamdy, PhD, FRCP + 44 161 2064363 shaheen.hamdy@manchester.ac.uk

Locations
United Kingdom
Salford Royal Hospital Recruiting
Salford, Manchester, United Kingdom, M6 8HD
Sponsors and Collaborators
University of Manchester
Salford Royal NHS Foundation Trust
Investigators
Principal Investigator: Shaheen Hamdy, PhD FRCP University of Manchester

Responsible Party: Prof Shaheen Hamdy PhD FRCP, Professor of Neurogastroenterology, University of Manchester
ClinicalTrials.gov Identifier: NCT03253354     History of Changes
Other Study ID Numbers: IRAS: 200591
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymized swallowing physiology data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Diseases
Parkinson Disease
Deglutition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases