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Multimodal Neuromodulation in Individuals With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT05105776
Recruitment Status : Recruiting
First Posted : November 3, 2021
Last Update Posted : August 10, 2022
Sponsor:
Collaborators:
Pacific Parkinson's Research Institute
University of British Columbia
Information provided by (Responsible Party):
Ryan D'Arcy, HealthTech Connex Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Galvanic stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Galvanic stimulation is masked (sham vs active)
Primary Purpose: Treatment
Official Title: Multimodal Neuromodulation in Individuals With Parkinson's Disease
Actual Study Start Date : February 9, 2022
Estimated Primary Completion Date : December 15, 2023
Estimated Study Completion Date : June 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Physiotherapy only
Experimental: Active galvanic stimulation (GVS; week 1) to sham GVS (week 2)
Physiotherapy + translingual neurostimulation provided throughout
 Device: Galvanic stimulation
Galvanic stimulation during physiotherapy sessions
Experimental: Sham GVS (week 1) to active GVS (week 2)
Physiotherapy + translingual neurostimulation provided throughout
 Device: Galvanic stimulation
Galvanic stimulation during physiotherapy sessions
Experimental: Active GVS throughout weeks 1 + 2
Physiotherapy + translingual neurostimulation provided throughout
 Device: Galvanic stimulation
Galvanic stimulation during physiotherapy sessions


Outcome Measures
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Primary Outcome Measures :
  1. NeuroCom Sensory Organization Test (SOT) [ Time Frame: Baseline to week 4 ]
    Composite balance score

  2. NeuroCom Limits of Stability test (LOS) [ Time Frame: Baseline to week 4 ]
    Postural stability score

  3. NeuroCom Adaptation Test [ Time Frame: Baseline to week 4 ]
    Adaptation score

  4. MiniBESTest [ Time Frame: Baseline to week 4 ]
    Balance score


Secondary Outcome Measures :
  1. Electroencephalography - amplitudes [ Time Frame: Baseline to week 4 ]
    Measured with NeuroCatch Platform 2 (NCP)

  2. Electroencephalography - latencies [ Time Frame: Baseline to week 4 ]
    Measured with NeuroCatch Platform 2 (NCP)

  3. Unified Parkinson's Disease Rating Scale [ Time Frame: Baseline to week 4 ]
    Part II and part III: Motor function score

  4. Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline to week 4 ]
    Cognitive test; total score


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05105776


Contacts
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Contact: Natasha Campbell 778-874-7758 natashacampbell@healthtechconnex.com

Locations
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Canada, British Columbia
Centre for Neurology Studies Recruiting
Surrey, British Columbia, Canada, V3V 0C6
Contact: Natasha Campbell    778-874-7758    natashacampbell@healthtechconnex.com   
Principal Investigator: Ryan D'Arcy, PhD         
Sub-Investigator: Martin McKeown, MD         
Sponsors and Collaborators
Ryan D'Arcy
Pacific Parkinson's Research Institute
University of British Columbia
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ryan D'Arcy, Principal Investigator, HealthTech Connex Inc.
ClinicalTrials.gov Identifier: NCT05105776    
Other Study ID Numbers: CNS_PD_001
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases