Parkinson DiseaseNCT05105776
Multimodal Neuromodulation in Individuals With Parkinson's Disease
A study testing Galvanic stimulation in people with Parkinson Disease, run by Ryan D'Arcy at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Galvanic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 9 Feb 2022to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Galvanic stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galvanic stimulationDevice
Galvanic stimulation during physiotherapy sessions
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy only | No intervention | Not described |
| Active galvanic stimulation (GVS; week 1) to sham GVS (week 2) | Experimental | Physiotherapy + translingual neurostimulation provided throughout Receives: Device: Galvanic stimulation |
| Sham GVS (week 1) to active GVS (week 2) | Experimental | Physiotherapy + translingual neurostimulation provided throughout Receives: Device: Galvanic stimulation |
| Active GVS throughout weeks 1 + 2 | Experimental | Physiotherapy + translingual neurostimulation provided throughout Receives: Device: Galvanic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
NeuroCom Sensory Organization Test (SOT)
Composite balance score
Measured: Baseline to week 4
NeuroCom Limits of Stability test (LOS)
Postural stability score
Measured: Baseline to week 4
NeuroCom Adaptation Test
Adaptation score
Measured: Baseline to week 4
MiniBESTest
Balance score
Measured: Baseline to week 4
Secondary outcomes (4)
Electroencephalography - amplitudes
Measured with NeuroCatch Platform 2 (NCP)
Measured: Baseline to week 4
Electroencephalography - latencies
Measured with NeuroCatch Platform 2 (NCP)
Measured: Baseline to week 4
Unified Parkinson's Disease Rating Scale
Part II and part III: Motor function score
Measured: Baseline to week 4
Montreal Cognitive Assessment (MoCA)
Cognitive test; total score
Measured: Baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start9 Feb 2022
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryan D'Arcy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pacific Parkinson's Research Institute, University of British Columbia
- Responsible party
- Sponsor-investigator, Ryan D'Arcy, HealthTech Connex Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105776
- Sponsor's protocol ID
- CNS_PD_001
- Status last verified
- May 2024
- First submitted
- 22 Oct 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Neuromodulation in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05105776
- Acronym / sponsor ID
- CNS_PD_001
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ryan D'ArcyIndustry (pharma, biotech, devices)
- Collaborators
- Pacific Parkinson's Research Institute, University of British Columbia
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy only | No intervention | – |
| Active galvanic stimulation (GVS; week 1) to sham GVS (week 2) | Experimental | Device: Galvanic stimulationPhysiotherapy + translingual neurostimulation provided throughout |
| Sham GVS (week 1) to active GVS (week 2) | Experimental | Device: Galvanic stimulationPhysiotherapy + translingual neurostimulation provided throughout |
| Active GVS throughout weeks 1 + 2 | Experimental | Device: Galvanic stimulationPhysiotherapy + translingual neurostimulation provided throughout |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galvanic stimulationGalvanic stimulation during physiotherapy sessions | Device | 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) |
Primary outcome
NeuroCom Sensory Organization Test (SOT)
Time frame: Baseline to week 4
Composite balance score
NeuroCom Limits of Stability test (LOS)
Time frame: Baseline to week 4
Postural stability score
NeuroCom Adaptation Test
Time frame: Baseline to week 4
Adaptation score
MiniBESTest
Time frame: Baseline to week 4
Balance score
4 secondary outcomes
Electroencephalography - amplitudes
Time frame: Baseline to week 4
Electroencephalography - latencies
Time frame: Baseline to week 4
Unified Parkinson's Disease Rating Scale
Time frame: Baseline to week 4
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galvanic stimulation in people with Parkinson Disease, run by Ryan D'Arcy at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NeuroCom Sensory Organization Test (SOT) (time frame: Baseline to week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.