Back to resultsNeurostimulation for Dysphagia in Parkinson's Disease
Primary Purpose
Dysphagia, Parkinson Disease, Swallowing Disorder.Other Specified
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
repetitive magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia
Eligibility 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
Sites / Locations
- Salford Royal Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Pharyngeal stimulation
repetitive magnetic stimulation (1Hz)
repetitive magnetic stimulation (5Hz)
Sham treatment
Arm Description
Pharyngeal stimulation given at 5Hz for 10 minutes
repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses
repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses
Sham repetitive transcranial magnetic stimulation using the coil tilt technique
Outcomes
Primary Outcome Measures
Videofluoroscopy
Changes in penetration aspiration scale
Secondary Outcome Measures
Brain excitability
Measures of brain function to single pulse TMS
Full Information
NCT ID
NCT03253354
First Posted
August 15, 2017
Last Updated
June 8, 2022
Sponsor
University of Manchester
Collaborators
Northern Care Alliance NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03253354
Brief Title
Neurostimulation for Dysphagia in Parkinson's Disease
Official Title
Exploring Novel Neurostimulation Based Therapies for Swallowing Impairments in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
Northern Care Alliance NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Parkinson Disease, Swallowing Disorder.Other Specified, Brain Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 arm randomised single dose study
Masking
Participant
Masking Description
Patient blinding
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharyngeal stimulation
Arm Type
Active Comparator
Arm Description
Pharyngeal stimulation given at 5Hz for 10 minutes
Arm Title
repetitive magnetic stimulation (1Hz)
Arm Type
Active Comparator
Arm Description
repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses
Arm Title
repetitive magnetic stimulation (5Hz)
Arm Type
Active Comparator
Arm Description
repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
Sham repetitive transcranial magnetic stimulation using the coil tilt technique
Intervention Type
Device
Intervention Name(s)
repetitive magnetic stimulation
Other Intervention Name(s)
pharyngeal stimulation
Intervention Description
Neurostimulation
Primary Outcome Measure Information:
Title
Videofluoroscopy
Description
Changes in penetration aspiration scale
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Brain excitability
Description
Measures of brain function to single pulse TMS
Time Frame
Immediately after, 30 and 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaheen Hamdy, PhD FRCP
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salford Royal Hospital
City
Salford
State/Province
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Anonymized swallowing physiology data
Learn more about this trial
Neurostimulation for Dysphagia in Parkinson's Disease
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