Essential Tremor
Conditions
Brief summary
This is randomized double-blind study to study the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex improves tremor in patients with essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other half of the right hemisphere.
Interventions
DEVICEtSMS
Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability (Oliviero et al., 2011; Oliviero et al., 2015; Dileone et al., 2018). Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the left or right motor cortex, using a tSMS helmet (MAGmv1.0; Neurek SL, Toledo, Spain).
DEVICEsham
A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain) of motor cortex contralateral to the stimulated hemisphere.
Sponsors
Fundación de investigación HM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Essential tremor
Exclusion criteria
* MRI-incompatible metal objects in the body (e.g. cardiac pacemakers) * other main neuropsychiatric co-morbidity * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry. | Immediately after treatment compared baseline |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry. | 15 minutes after treatment compared to baseline |
| Change from baseline in rest tremor amplitude, as measured by accelerometry. | Immediately after treatment and 15 minutes after treatment compared baseline. |
| Change from baseline in tremor frequency, as measured by accelerometry. | Immediately after treatment and 15 minutes after treatment compared baseline. |
| Change from baseline in the Clinical Rating Scale for Tremor part B (drawing) | 5 minutes after treatment and 20 minutes after treatment compared to baseline |
Countries
Spain
Outcome results
None listed