DysphagiaNCT03253354
Neurostimulation for Dysphagia in Parkinson's Disease
A study testing repetitive magnetic stimulation in people with Dysphagia and Parkinson Disease, run by University of Manchester at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Parkinson Disease, Swallowing Disorder.Other Specified
- What is being tested?
- repetitive magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2017to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Parkinson's Disease with dysphagia
Who cannot join
- Contraindications to magnetic stimulation, such as pacemakers, significant neuroleptic medications, pregnancy Other causes for dysphagia Unable to give informed written consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salford Royal Hospital
Salford, Manchester, M6 8HD
About this study
Official title: 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
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.
- Being tested
- repetitive magnetic stimulation
- Medical subject headings
- Deglutition Disorders, Parkinson Disease, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive magnetic stimulationDevice
Also called pharyngeal stimulation
Neurostimulation
| Study group | Role | What they receive |
|---|---|---|
| Pharyngeal stimulation | Active comparator | Pharyngeal stimulation given at 5Hz for 10 minutes Receives: Device: repetitive magnetic stimulation |
| repetitive magnetic stimulation (1Hz) | Active comparator | repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses Receives: Device: repetitive magnetic stimulation |
| repetitive magnetic stimulation (5Hz) | Active comparator | repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses Receives: Device: repetitive magnetic stimulation |
| Sham treatment | Sham comparator | Sham repetitive transcranial magnetic stimulation using the coil tilt technique Receives: Device: repetitive magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Videofluoroscopy
Changes in penetration aspiration scale
Measured: 1 hour
Secondary outcomes (1)
Brain excitability
Measures of brain function to single pulse TMS
Measured: Immediately after, 30 and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Aug 2017
- Primary completion30 Apr 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 arm randomised single dose study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Responsible party
- Principal investigator, Prof Shaheen Hamdy PhD FRCP, University of Manchester
- Investigators
- Shaheen Hamdy, PhD FRCP, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253354
- Sponsor's protocol ID
- IRAS: 200591
- Status last verified
- Jun 2022
- First submitted
- 15 Aug 2017
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized swallowing physiology data
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Novel Neurostimulation Based Therapies for Swallowing Impairments in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03253354
- Acronym / sponsor ID
- IRAS: 200591
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 4 arm randomised single dose study
| Arm | Type | Receives |
|---|---|---|
| Pharyngeal stimulation | Active comparator | Device: repetitive magnetic stimulationPharyngeal stimulation given at 5Hz for 10 minutes |
| repetitive magnetic stimulation (1Hz) | Active comparator | Device: repetitive magnetic stimulationrepetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses |
| repetitive magnetic stimulation (5Hz) | Active comparator | Device: repetitive magnetic stimulationrepetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses |
| Sham treatment | Sham comparator | Device: repetitive magnetic stimulationSham repetitive transcranial magnetic stimulation using the coil tilt technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed Parkinson's Disease with dysphagia
Key exclusion criteria (1 listed)
- Contraindications to magnetic stimulation, such as pacemakers, significant neuroleptic medications, pregnancy Other causes for dysphagia Unable to give informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive magnetic stimulationAlso: pharyngeal stimulationNeurostimulation | Device | Pharyngeal stimulation, Sham treatment, repetitive magnetic stimulation (1Hz), repetitive magnetic stimulation (5Hz) |
Primary outcome
Videofluoroscopy
Time frame: 1 hour
Changes in penetration aspiration scale
1 secondary outcome
Brain excitability
Time frame: Immediately after, 30 and 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: Undecided. Anonymized swallowing physiology data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaheen Hamdy, PhD FRCP principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive magnetic stimulation in people with Dysphagia and Parkinson Disease, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Videofluoroscopy (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.