Multimodal Neuromodulation in Individuals With Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Galvanic stimulation

• Registration Number: NCT05105776
• Lead Sponsor: Ryan D'Arcy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-11-03
• Study Start: 2022-02-09
• Status Verified: 2024-05
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-02
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham GVS (week 1) to active GVS (week 2)	Galvanic stimulation	Physiotherapy + translingual neurostimulation provided throughout
Active galvanic stimulation (GVS; week 1) to sham GVS (week 2)	Galvanic stimulation	Physiotherapy + translingual neurostimulation provided throughout
Active GVS throughout weeks 1 + 2	Galvanic stimulation	Physiotherapy + translingual neurostimulation provided throughout

Primary Outcome Measures

Name	Time	Method
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
MiniBESTest	Baseline to week 4	Balance score

Secondary Outcome Measures

Name	Time	Method
Electroencephalography - latencies	Baseline to week 4	Measured with NeuroCatch Platform 2 (NCP)
Electroencephalography - amplitudes	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
Montreal Cognitive Assessment (MoCA)	Baseline to week 4	Cognitive test; total score

Trial Locations

Locations (1)

Centre for Neurology Studies; 🇨🇦 Surrey, British Columbia, Canada