NCT03253354

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

3.7 years

First QC Date

August 15, 2017

Last Update Submit

June 8, 2022

Conditions

DysphagiaParkinson DiseaseSwallowing Disorder.Other SpecifiedBrain Diseases

Outcome Measures

Primary Outcomes (1)

  • Videofluoroscopy

    Changes in penetration aspiration scale

    1 hour

Secondary Outcomes (1)

  • Brain excitability

    Immediately after, 30 and 60 minutes

Study Arms (4)

Pharyngeal stimulation

ACTIVE COMPARATOR

Pharyngeal stimulation given at 5Hz for 10 minutes

Device: repetitive magnetic stimulation

repetitive magnetic stimulation (1Hz)

ACTIVE COMPARATOR

repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses

Device: repetitive magnetic stimulation

repetitive magnetic stimulation (5Hz)

ACTIVE COMPARATOR

repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses

Device: repetitive magnetic stimulation

Sham treatment

SHAM COMPARATOR

Sham repetitive transcranial magnetic stimulation using the coil tilt technique

Device: repetitive magnetic stimulation

Interventions

repetitive magnetic stimulationDEVICE

Neurostimulation

Also known as: pharyngeal stimulation
Pharyngeal stimulationSham treatmentrepetitive magnetic stimulation (1Hz)repetitive magnetic stimulation (5Hz)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed Parkinson's Disease with dysphagia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salford Royal Hospital

Salford, Manchester, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Deglutition DisordersParkinson DiseaseBrain Diseases

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesParkinsonian DisordersBasal Ganglia DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Shaheen Hamdy, PhD FRCP

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient blinding
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 4 arm randomised single dose study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurogastroenterology

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 17, 2017

Study Start

August 1, 2017

Primary Completion

April 30, 2021

Study Completion

August 30, 2021

Last Updated

June 9, 2022

Record last verified: 2022-06

Locations

GB(1)