Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis

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.

Conditions

• Multiple Sclerosis

Interventions

DEVICE

Transcranial Magnetic Stimulation (TMS)

By means of the magnetic stimulator we induce a cerebral electric current that is able to obtain a motor potential in the first dorsal interosseous bone of the left hand. The intervention procedure consists of two steps: First step: Obtaining the Motor Evoked Threshold at Rest: Each patient, regardless of to the group to which they belong will have his/her threshold evoked motor calculated at rest, by stimulation of the right motor cortex, evoking electromyographic responses in the contralateral muscles. Second step: Administration of TMS: To calculate the motive threshold as the percentage of the same to which the treatment will have to be applied, a device equipped with a coil. The treatment will be administered for 5 consecutive days, with 3 weeks of rest, between each stimulation. To complete a treatment period of 14 months. The stimulation with TMS will be carried out every day in the same time slot for 5 consecutive days every 4 weeks, during a period of 14 months.

DRUG

Placebos

Administration of Transcranial Magnetic Stimulation at 0 Hz (the patient will be only under drug standar therapy)

Sponsors & Collaborators

• Isaac Tunez-Fiñana

  collaborator UNKNOWN

• Eduardo Agüera-Morales

  collaborator UNKNOWN

• Maimónides Biomedical Research Institute of Córdoba

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2021-10-01

Completion

2022-10-01