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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.
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Inclusion and exclusion criteria
Inclusion Criteria:
A diagnosis of idiopathic PD
Disease staging between II and III (mild to moderate), according to the modified Hoehn and Yahr scale;
Currently taking prescribed antiparkinsonian medication regularly with:
No medication changes in the last 30 days
Responsive to oral dopamine replacement therapy
Score higher than 24, verified through the Montreal Cognitive Assessment33.
Must demonstrate moderate burden of motor symptoms (MDS-UPDRS part II >12 and MDS-UPDRS part III scores >35) 34
Must be able to voluntarily give written (or verbal) informed consent
Must have ability to reliably use the devices
Must be able to understand and complete all assessments (provided in English only)
Exclusion Criteria:
Diagnosis of atypical parkinsonism;
History of epilepsy
Presence of an implanted electrical device
Previous surgical intervention for PD (DBS implantation - deep brain stimulation);
Treated with a pump for continuous delivery of DRT (Dopamine replacement therapy)
Presence of severe freezing episodes.
Women who are pregnant or nursing
History of unstable mood disorder or unstable anxiety disorder or psychosis
Those with a recent history of substance abuse and/or dependence (alcohol or other drugs)
Have been diagnosed with neurological disease other than Parkinson's disease.
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
Have a diagnosed vestibular dysfunction
Have had eye surgery within the previous three months or ear surgery within the previous six months
Have participated in another clinical trial within the last 30 days or are currently enrolled in another interventional clinical trial
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
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
Primary purpose
Allocation
Interventional model
Masking
32 participants in 4 patient groups
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Central trial contact
Natasha Campbell
Data sourced from clinicaltrials.gov
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