Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis
Status:
Not yet recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Background: Transcranial Magnetic Stimulation (TMS) is a technique based on the principles of
electromagnetic induction. It applies pulses of magnetic radiation that penetrate the brain
tissue, and it is a non-invasive, painless and practically innocuous procedure. Previous
studies advocate the therapeutic capacity of TMS in several neurodegenerative and psychiatric
processes, both in animal models and in human studies. Its uses in Parkinson's disease,
Alzheimer's disease and in Huntington's chorea have shown improvement in the symptomatology
and in the molecular profile, and even in the cellular density of the brain. Consequently,
the extrapolation of these TMS results in the aforementioned neurodegenerative disease to
other entities with etiopathogenic and clinical analogy would raise the relevance and
feasibility of its use in multiple sclerosis (MS). The overall objective will be to
demonstrate the effectiveness of the TMS in terms of safety and clinical improvement, as well
as to observe the molecular changes in relation to the treatment.
Methods and design: Phase I clinical trial, unicentric, controlled, randomised, single blind.
A total of 90 patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) who meet
all the inclusion criteria and do not present any of the exclusion criteria that are
established and from which clinically evaluable results can be obtained. The patients
included will be assigned under the 1:1:1 randomization formula, constituting three groups
for the present study: 30 patients treated with natalizumab + white (placebo) + 30 patients
treated with natalizumab + TMS (1 Hertz) + 30 patients treated with natalizumab + TMS (5
Hertz).
Discussion: Results of this study will inform on the efficiency of the TMS for the treatment
of MS. The expected results are that TMS is a useful therapeutic resource to improve clinical
status (main parameters) and neurochemical profile (surrogate parameters); both types of
parameters will be checked.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba