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CompletedNCT03253354Updated Jun 9, 2022

Neurostimulation for Dysphagia in Parkinson's Disease

An interventional study of repetitive magnetic stimulation in Dysphagia, Parkinson Disease and Swallowing Disorder.Other Specified, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by University of Manchester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dysphagia
  • Parkinson Disease
  • Swallowing Disorder.Other Specified
  • Brain Diseases
03

In context

Deglutition Disorders

723 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 482 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

University of Manchester is the lead sponsor of 201 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Confirmed Parkinson's Disease with dysphagia

Exclusion criteria

Exclusion Criteria:

Contraindications to magnetic stimulation, such as pacemakers, significant neuroleptic medications, pregnancy Other causes for dysphagia Unable to give informed written consent

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Pharyngeal stimulation

    Pharyngeal stimulation given at 5Hz for 10 minutes

    Device: repetitive magnetic stimulation

  • Active comparator
    repetitive magnetic stimulation (1Hz)

    repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses

    Device: repetitive magnetic stimulation

  • Active comparator
    repetitive magnetic stimulation (5Hz)

    repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses

    Device: repetitive magnetic stimulation

  • Sham comparator
    Sham treatment

    Sham repetitive transcranial magnetic stimulation using the coil tilt technique

    Device: repetitive magnetic stimulation

Interventions

  • Devicerepetitive magnetic stimulation

    Neurostimulation

    Also known as: pharyngeal stimulation

06

What researchers measure

Primary outcomes

  1. Videofluoroscopy

    Changes in penetration aspiration scale

    Time frame: 1 hour

Secondary outcomes

  1. Brain excitability

    Measures of brain function to single pulse TMS

    Time frame: Immediately after, 30 and 60 minutes

07

Study locations

1 site
  • Salford Royal Hospital
    Salford, Manchester M6 8HD, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided — Anonymized swallowing physiology data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03253354
Collaborators
Northern Care Alliance NHS Foundation Trust
Responsible party
Prof Shaheen Hamdy PhD FRCP (Professor of Neurogastroenterology, University of Manchester) — Principal investigator
First posted
Aug 17, 2017
Start date
Aug 1, 2017
Primary completion
Apr 30, 2021
Completion
Aug 30, 2021
Last update
Jun 9, 2022

Study contacts

Shaheen Hamdy, PhD FRCP
principal investigator · University of Manchester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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