Multimodal Neuromodulation in Individuals With Parkinson's Disease

NCT05105776 | Completed

• 1 other identifier: CNS_PD_001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• NeuroCom Sensory Organization Test (SOT)

  Composite balance score

  Baseline to week 4

• NeuroCom Limits of Stability test (LOS)

  Postural stability score

  Baseline to week 4

• NeuroCom Adaptation Test

  Adaptation score

  Baseline to week 4

• MiniBESTest

  Balance score

  Baseline to week 4

Secondary Outcomes (4)

• Electroencephalography - amplitudes

  Baseline to week 4

• Electroencephalography - latencies

  Baseline to week 4

• Unified Parkinson's Disease Rating Scale

  Baseline to week 4

• Montreal Cognitive Assessment (MoCA)

  Baseline to week 4

Study Arms (4)

Physiotherapy only

NO INTERVENTION

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

EXPERIMENTAL

Physiotherapy + translingual neurostimulation provided throughout

Device: Galvanic stimulation

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

EXPERIMENTAL

Physiotherapy + translingual neurostimulation provided throughout

Device: Galvanic stimulation

Active GVS throughout weeks 1 + 2

EXPERIMENTAL

Physiotherapy + translingual neurostimulation provided throughout

Device: Galvanic stimulation

Interventions

Galvanic stimulation DEVICE

Galvanic stimulation during physiotherapy sessions

Active GVS throughout weeks 1 + 2; Active galvanic stimulation (GVS; week 1) to sham GVS (week 2); Sham GVS (week 1) to active GVS (week 2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• Ryan D'Arcy: lead
• Pacific Parkinson's Research Institute: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Centre for Neurology Studies

Surrey, British Columbia, V3V 0C6, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Galvanic stimulation is masked (sham vs active)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: February 9, 2022
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

CA (1)