Multimodal Neuromodulation in Individuals With Parkinson's Disease

NCT ID: NCT05105776

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-09
• Study Completion Date: 2024-05-02

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physiotherapy only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active galvanic stimulation (GVS; week 1) to sham GVS (week 2)

Physiotherapy + translingual neurostimulation provided throughout

Group Type: EXPERIMENTAL

Galvanic stimulation

Intervention Type: DEVICE

Galvanic stimulation during physiotherapy sessions

Sham GVS (week 1) to active GVS (week 2)

Physiotherapy + translingual neurostimulation provided throughout

Group Type: EXPERIMENTAL

Galvanic stimulation

Intervention Type: DEVICE

Galvanic stimulation during physiotherapy sessions

Active GVS throughout weeks 1 + 2

Physiotherapy + translingual neurostimulation provided throughout

Group Type: EXPERIMENTAL

Galvanic stimulation

Intervention Type: DEVICE

Galvanic stimulation during physiotherapy sessions

Interventions

Galvanic stimulation

Galvanic stimulation during physiotherapy sessions

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacific Parkinson's Research Institute

UNKNOWN

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Ryan D'Arcy

INDUSTRY

Sponsor Role: lead

Responsible Party

Ryan D'Arcy

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Centre for Neurology Studies

Surrey, British Columbia, Canada

Countries

Canada

Other Identifiers

CNS_PD_001

Identifier Type: -

Identifier Source: org_study_id