Multimodal Neuromodulation in Individuals With Parkinson's Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Ryan D'Arcy
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- NeuroCom Sensory Organization Test (SOT)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Ryan D'Arcy
Principal Investigator
HealthTech Connex Inc.
Eligibility 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 Assessment
- •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.
Outcomes
Primary Outcomes
NeuroCom Sensory Organization Test (SOT)
Time Frame: Baseline to week 4
Composite balance score
NeuroCom Limits of Stability test (LOS)
Time Frame: Baseline to week 4
Postural stability score
NeuroCom Adaptation Test
Time Frame: Baseline to week 4
Adaptation score
MiniBESTest
Time Frame: Baseline to week 4
Balance score
Secondary Outcomes
- Electroencephalography - latencies(Baseline to week 4)
- Electroencephalography - amplitudes(Baseline to week 4)
- Unified Parkinson's Disease Rating Scale(Baseline to week 4)
- Montreal Cognitive Assessment (MoCA)(Baseline to week 4)