search
Back to results

Multimodal Neuromodulation in Individuals With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Galvanic stimulation
Sponsored by
Ryan D'Arcy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Neurology StudiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Physiotherapy only

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

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

Active GVS throughout weeks 1 + 2

Arm Description

Physiotherapy + translingual neurostimulation provided throughout

Physiotherapy + translingual neurostimulation provided throughout

Physiotherapy + translingual neurostimulation provided throughout

Outcomes

Primary Outcome Measures

NeuroCom Sensory Organization Test (SOT)
Composite balance score
NeuroCom Limits of Stability test (LOS)
Postural stability score
NeuroCom Adaptation Test
Adaptation score
MiniBESTest
Balance score

Secondary Outcome Measures

Electroencephalography - amplitudes
Measured with NeuroCatch Platform 2 (NCP)
Electroencephalography - latencies
Measured with NeuroCatch Platform 2 (NCP)
Unified Parkinson's Disease Rating Scale
Part II and part III: Motor function score
Montreal Cognitive Assessment (MoCA)
Cognitive test; total score

Full Information

First Posted
October 22, 2021
Last Updated
September 20, 2023
Sponsor
Ryan D'Arcy
Collaborators
Pacific Parkinson's Research Institute, University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT05105776
Brief Title
Multimodal Neuromodulation in Individuals With Parkinson's Disease
Official Title
Multimodal Neuromodulation in Individuals With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ryan D'Arcy
Collaborators
Pacific Parkinson's Research Institute, University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Galvanic stimulation is masked (sham vs active)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy only
Arm Type
No Intervention
Arm Title
Active galvanic stimulation (GVS; week 1) to sham GVS (week 2)
Arm Type
Experimental
Arm Description
Physiotherapy + translingual neurostimulation provided throughout
Arm Title
Sham GVS (week 1) to active GVS (week 2)
Arm Type
Experimental
Arm Description
Physiotherapy + translingual neurostimulation provided throughout
Arm Title
Active GVS throughout weeks 1 + 2
Arm Type
Experimental
Arm Description
Physiotherapy + translingual neurostimulation provided throughout
Intervention Type
Device
Intervention Name(s)
Galvanic stimulation
Intervention Description
Galvanic stimulation during physiotherapy sessions
Primary Outcome Measure Information:
Title
NeuroCom Sensory Organization Test (SOT)
Description
Composite balance score
Time Frame
Baseline to week 4
Title
NeuroCom Limits of Stability test (LOS)
Description
Postural stability score
Time Frame
Baseline to week 4
Title
NeuroCom Adaptation Test
Description
Adaptation score
Time Frame
Baseline to week 4
Title
MiniBESTest
Description
Balance score
Time Frame
Baseline to week 4
Secondary Outcome Measure Information:
Title
Electroencephalography - amplitudes
Description
Measured with NeuroCatch Platform 2 (NCP)
Time Frame
Baseline to week 4
Title
Electroencephalography - latencies
Description
Measured with NeuroCatch Platform 2 (NCP)
Time Frame
Baseline to week 4
Title
Unified Parkinson's Disease Rating Scale
Description
Part II and part III: Motor function score
Time Frame
Baseline to week 4
Title
Montreal Cognitive Assessment (MoCA)
Description
Cognitive test; total score
Time Frame
Baseline to week 4

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of idiopathic PD Disease staging between II and III (mild to moderate), according to the modified Hoehn and Yahr scale; Currently taking prescribed antiparkinsonian medication regularly with: No medication changes in the last 30 days Responsive to oral dopamine replacement therapy Score higher than 24, verified through the Montreal Cognitive Assessment33. Must demonstrate moderate burden of motor symptoms (MDS-UPDRS part II >12 and MDS-UPDRS part III scores >35) 34 Must be able to voluntarily give written (or verbal) informed consent Must have ability to reliably use the devices Must be able to understand and complete all assessments (provided in English only) Exclusion Criteria: Diagnosis of atypical parkinsonism; History of epilepsy Presence of an implanted electrical device Previous surgical intervention for PD (DBS implantation - deep brain stimulation); Treated with a pump for continuous delivery of DRT (Dopamine replacement therapy) Presence of severe freezing episodes. Women who are pregnant or nursing History of unstable mood disorder or unstable anxiety disorder or psychosis Those with a recent history of substance abuse and/or dependence (alcohol or other drugs) Have been diagnosed with neurological disease other than Parkinson's disease. 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 Have a diagnosed vestibular dysfunction Have had eye surgery within the previous three months or ear surgery within the previous six months Have participated in another clinical trial within the last 30 days or are currently enrolled in another interventional clinical trial 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Campbell
Phone
778-874-7758
Email
natashacampbell@healthtechconnex.com
Facility Information:
Facility Name
Centre for Neurology Studies
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Campbell
Phone
778-874-7758
Email
natashacampbell@healthtechconnex.com
First Name & Middle Initial & Last Name & Degree
Ryan D'Arcy, PhD
First Name & Middle Initial & Last Name & Degree
Martin McKeown, MD

12. IPD Sharing Statement

Learn more about this trial

Multimodal Neuromodulation in Individuals With Parkinson's Disease

We'll reach out to this number within 24 hrs