Multimodal Neuromodulation in Individuals With Parkinson's Disease

September 20, 2023 updated by: Ryan D'Arcy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Recruiting
        • Centre for Neurology Studies
        • Principal Investigator:
          • Ryan D'Arcy, PhD
        • Sub-Investigator:
          • Martin McKeown, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NeuroCom Sensory Organization Test (SOT)
Time Frame: Baseline to week 4
Composite balance score
Baseline to week 4
NeuroCom Limits of Stability test (LOS)
Time Frame: Baseline to week 4
Postural stability score
Baseline to week 4
NeuroCom Adaptation Test
Time Frame: Baseline to week 4
Adaptation score
Baseline to week 4
MiniBESTest
Time Frame: Baseline to week 4
Balance score
Baseline to week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography - amplitudes
Time Frame: Baseline to week 4
Measured with NeuroCatch Platform 2 (NCP)
Baseline to week 4
Electroencephalography - latencies
Time Frame: Baseline to week 4
Measured with NeuroCatch Platform 2 (NCP)
Baseline to week 4
Unified Parkinson's Disease Rating Scale
Time Frame: Baseline to week 4
Part II and part III: Motor function score
Baseline to week 4
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline to week 4
Cognitive test; total score
Baseline to week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryan D'Arcy

Collaborators

University of British Columbia
Pacific Parkinson's Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2022

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNS_PD_001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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