Neurostimulation for Dysphagia in Parkinson's Disease

June 8, 2022 updated by: Prof Shaheen Hamdy PhD FRCP, University of Manchester

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Manchester
      • Salford, Manchester, United Kingdom, M6 8HD
        • Salford Royal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pharyngeal stimulation
Pharyngeal stimulation given at 5Hz for 10 minutes
Device: repetitive magnetic stimulation
Neurostimulation
Other Names:
  • pharyngeal stimulation
ACTIVE_COMPARATOR: repetitive magnetic stimulation (1Hz)
repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses
Device: repetitive magnetic stimulation
Neurostimulation
Other Names:
  • pharyngeal stimulation
ACTIVE_COMPARATOR: repetitive magnetic stimulation (5Hz)
repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses
Device: repetitive magnetic stimulation
Neurostimulation
Other Names:
  • pharyngeal stimulation
SHAM_COMPARATOR: Sham treatment
Sham repetitive transcranial magnetic stimulation using the coil tilt technique
Device: repetitive magnetic stimulation
Neurostimulation
Other Names:
  • pharyngeal stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Videofluoroscopy
Time Frame: 1 hour
Changes in penetration aspiration scale
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain excitability
Time Frame: Immediately after, 30 and 60 minutes
Measures of brain function to single pulse TMS
Immediately after, 30 and 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Collaborators

Northern Care Alliance NHS Foundation Trust

Investigators

  • Principal Investigator: Shaheen Hamdy, PhD FRCP, University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

August 30, 2021

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (ACTUAL)

August 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS: 200591

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized swallowing physiology data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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