Multimodal Neuromodulation in Individuals With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Multimodal Neuromodulation in Individuals With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05105776
• Other study ID #: CNS_PD_001
• Status: Completed
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: May 2, 2024

Study information

• Verified date: May 2024
• Source: HealthTech Connex Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Galvanic stimulation
Galvanic stimulation during physiotherapy sessions

Locations

Country	Name	City	State
Canada	Centre for Neurology Studies	Surrey	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Ryan D'Arcy	Pacific Parkinson's Research Institute, University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NeuroCom Sensory Organization Test (SOT)	Composite balance score	Baseline to week 4
Primary	NeuroCom Limits of Stability test (LOS)	Postural stability score	Baseline to week 4
Primary	NeuroCom Adaptation Test	Adaptation score	Baseline to week 4
Primary	MiniBESTest	Balance score	Baseline to week 4
Secondary	Electroencephalography - amplitudes	Measured with NeuroCatch Platform 2 (NCP)	Baseline to week 4
Secondary	Electroencephalography - latencies	Measured with NeuroCatch Platform 2 (NCP)	Baseline to week 4
Secondary	Unified Parkinson's Disease Rating Scale	Part II and part III: Motor function score	Baseline to week 4
Secondary	Montreal Cognitive Assessment (MoCA)	Cognitive test; total score	Baseline to week 4