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| Name | Class |
|---|---|
| Northern Care Alliance NHS Foundation Trust | OTHER |
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This study will explore the effects of 3 different neurostimulation methods on swallowing function in patients with dysphagia secondary to Parkinson's Disease
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharyngeal stimulation | Active Comparator | Pharyngeal stimulation given at 5Hz for 10 minutes |
|
| repetitive magnetic stimulation (1Hz) | Active Comparator | repetitive transcranial magnetic stimulation at 1Hz applied for 600 pulses |
|
| repetitive magnetic stimulation (5Hz) | Active Comparator | repetitive transcranial magnetic stimulation at 5Hz applied for 600 pulses |
|
| Sham treatment | Sham Comparator | Sham repetitive transcranial magnetic stimulation using the coil tilt technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive magnetic stimulation | Device | Neurostimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Videofluoroscopy | Changes in penetration aspiration scale | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Brain excitability | Measures of brain function to single pulse TMS | Immediately after, 30 and 60 minutes |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Shaheen Hamdy, PhD FRCP | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salford Royal Hospital | Salford | Manchester | M6 8HD | United Kingdom |
Anonymized swallowing physiology data
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D010300 | Parkinson Disease |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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4 arm randomised single dose study
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Patient blinding
|
| D010038 | Otorhinolaryngologic Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |