Parkinson's Disease
Conditions
Brief summary
This is a pilot open study to test the hypothesis that home-based transcranial static magnetic field stimulation (tSMS) of the supplementary motor area is safe and feasible to modulate corticostriatal activity in patients with Parkinson's disease.
Interventions
DEVICETranscranial static magnetic field stimulation (tSMS) of the supplementary motor area
Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability. Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. The investigators will use a cylindrical neodymium magnet of 60 mm diameter and 30 mm of thickness (MAG60r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the supplementary motor area (SMA) using an ergonomic helmet (MAGsv1.1, Neurek SL, Toledo, Spain).
Sponsors
Fundación de investigación HM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* idiopathic Parkinson's disease (Brain Bank criteria) * optimal clinical response to dopaminergic medication (\>30% MDS-UPDRS-III improvement)
Exclusion criteria
* MRI-incompatible metal objects in the body (e.g. cardiac pacemakers) * presence of levodopa-induced dyskinesias * other main neuropsychiatric co-morbidity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (safety) | From the start to 3 months after the end of treatment (5 months) | Number of device-related AE |
| Feasibility of home-based tSMS | From the start to the end of treatment (8 weeks) | Number of home-based tSMS sessions completed, according to patient's diaries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective improvement | Within one week after the end of treatment compared to baseline | Patient global impression of change (PGIC) |
| Motor improvement | Within one week after the end of treatment compared to baseline | MDS-UDPRS III scale |
| Sleep improvement | Within one week after the end of treatment compared to baseline | SCOPA-sleep scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in corticostriatal activity by resting-state fMRI | Within one week after the end of treatment compared to baseline | Functional connectivity between SMA and motor striatum |
| Changes in corticostriatal activity by FDG-PET | Within one week after the end of treatment compared to baseline | FDG-PET uptake in SMA and motor striatum |
| Changes in corticostriatal microstructure by diffusion-tensor imaging (DTI) | Within one week after the end of treatment compared to baseline | Fractional anisotropy and diffusivity in SMA and motor striatum. |
| Change in corticospinal excitability | Within one week after the end of treatment compared to baseline | Amplitude of motor evoked potentials (MEPs) evoked by transcranial magnetic stimulation of the motor cortex |
Countries
Spain
Contacts
Primary ContactGuglielmo Foffani, PhD
Outcome results
None listed