Parkinson Disease
Conditions
Brief summary
Multimodal non-invasive neuromodulation paired with physical therapy is a promising treatment modality for Parkinson's Disease (PD), however the optimal stimulation method, dose, and associated therapeutic protocol for long-lasting clinical benefits have not yet been identified for this population. Here the investigators aim to develop and execute a preliminary clinical study exploring the potential benefits of multimodal non-invasive neuromodulation. The therapeutic intervention will involve translingual neurostimulation +/- galvanic neurostimulation, paired with an intensive physical and cognitive therapy program.
Interventions
DEVICEGalvanic stimulation
Galvanic stimulation during physiotherapy sessions
Sponsors
Pacific Parkinson's Research Institute
University of British Columbia
Ryan D'Arcy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Galvanic stimulation is masked (sham vs active)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of idiopathic PD 2. Disease staging between II and III (mild to moderate), according to the modified Hoehn and Yahr scale; 3. Currently taking prescribed antiparkinsonian medication regularly with: 4. No medication changes in the last 30 days 5. Responsive to oral dopamine replacement therapy 6. Score higher than 24, verified through the Montreal Cognitive Assessment33. 7. Must demonstrate moderate burden of motor symptoms (MDS-UPDRS part II \>12 and MDS-UPDRS part III scores \>35) 34 8. Must be able to voluntarily give written (or verbal) informed consent 9. Must have ability to reliably use the devices 10. Must be able to understand and complete all assessments (provided in English only)
Exclusion criteria
11. Diagnosis of atypical parkinsonism; 12. History of epilepsy 13. Presence of an implanted electrical device 14. Previous surgical intervention for PD (DBS implantation - deep brain stimulation); 15. Treated with a pump for continuous delivery of DRT (Dopamine replacement therapy) 16. Presence of severe freezing episodes. 17. Women who are pregnant or nursing 18. History of unstable mood disorder or unstable anxiety disorder or psychosis 19. Those with a recent history of substance abuse and/or dependence (alcohol or other drugs) 20. Have been diagnosed with neurological disease other than Parkinson's disease. 21. Have a major concomitant illness or illnesses including cancer or disease of the cardiovascular, respiratory and/or renal systems deemed significant medical risk in the opinion of the principle investigator 22. Have a diagnosed vestibular dysfunction 23. Have had eye surgery within the previous three months or ear surgery within the previous six months 24. Have participated in another clinical trial within the last 30 days or are currently enrolled in another interventional clinical trial 25. Contraindicated for PoNS, including: 25.1. Current disease or sensitivity of the oral cavity 25.2. History of oral cancer 25.3. Oral surgery within three months of screening 25.4. Oral cavity piercings that could interfere with PoNSTM use 25.5. Sensitivity to Nickel, Copper, or Gold 25.6. Currently enrolled in a PoNSTM treatment program or use of the PoNSTM device in the last 5 weeks 25.7. History of penetrating brain injuries 25.8. Chronic infectious disease 25.9. Unmanaged hypertension 25.10. Diabetes 25.11. History of seizures 26. Contraindicated for GVS, including: 26.1. Metallic brain implant(s) 26.2. Brain surgery within the past six months 26.3. Highly sensitive skin behind the ears
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MiniBESTest | Baseline to week 4 | Balance score |
| NeuroCom Sensory Organization Test (SOT) | Baseline to week 4 | Composite balance score |
| NeuroCom Limits of Stability test (LOS) | Baseline to week 4 | Postural stability score |
| NeuroCom Adaptation Test | Baseline to week 4 | Adaptation score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electroencephalography - latencies | Baseline to week 4 | Measured with NeuroCatch Platform 2 (NCP) |
| Unified Parkinson's Disease Rating Scale | Baseline to week 4 | Part II and part III: Motor function score |
| Electroencephalography - amplitudes | Baseline to week 4 | Measured with NeuroCatch Platform 2 (NCP) |
| Montreal Cognitive Assessment (MoCA) | Baseline to week 4 | Cognitive test; total score |
Countries
Canada
Outcome results
None listed