Multimodal Neuromodulation in Individuals With Parkinson's Disease

H

HealthTech Connex

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: Galvanic stimulation

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05105776
CNS_PD_001

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

32 participants in 4 patient groups

Physiotherapy only
No Intervention group
Active galvanic stimulation (GVS; week 1) to sham GVS (week 2)
Experimental group
Description:
Physiotherapy + translingual neurostimulation provided throughout
Treatment:
Device: Galvanic stimulation
Sham GVS (week 1) to active GVS (week 2)
Experimental group
Description:
Physiotherapy + translingual neurostimulation provided throughout
Treatment:
Device: Galvanic stimulation
Active GVS throughout weeks 1 + 2
Experimental group
Description:
Physiotherapy + translingual neurostimulation provided throughout
Treatment:
Device: Galvanic stimulation

Trial contacts and locations

1

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Central trial contact

Natasha Campbell

Data sourced from clinicaltrials.gov

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