1,000
Participants
Start Date
December 10, 2019
Primary Completion Date
December 28, 2024
Study Completion Date
December 28, 2025
lumbar puncture and blood withdrawal
lumbar puncture performed to detect OCB for diagnostic purposes and blood withdrawal for SNP screening
Intermittent theta burst stimulation (iTBS) therapeutic protocol for spasticity
iTBS will be delivered over the scalp site corresponding to the leg area of primary motor cortex contralateral to the affected limb. The active motor threshold (AMT) will be defined as the minimum stimulation intensity required to evoke a liminal motor potential from the Soleus muscle during voluntary contraction. The stimulation intensity will be about 80% of AMT. The iTBS stimulation protocol consists of 10 bursts, each burst composed of three stimuli at 50 Hz, repeated at a theta frequency of 5 Hz every 10 s for a total of 600 stimuli (200 s). If no MEP will be detectable from the contralateral leg, the site of stimulation will be determined as symmetrical to the motor hot spot. If no MEP will be detectable even from the contralateral leg the coil will be held tangentially to the scalp with its centre placed 1 cm ahead and 1 cm lateral from CZ (10-20 EEG system). In these cases, stimulation intensity will be set to 50% of the maximum stimulator output.
RECRUITING
IRCCS Neuromed, Pozzilli
Neuromed IRCCS
OTHER