NCT04062331

Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis

Status unknown Phase 1, PHASE2 Last updated 21 August 2019

What this trial tests

Phase 1, PHASE2 trial testing Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis in 90 participants. Status unknown.

Timeline

1 October 2019

Primary endpoint
1 October 2021

1 October 2022

Quick facts

Lead sponsor	Maimónides Biomedical Research Institute of Córdoba
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	90
Start date	1 October 2019
Primary completion	1 October 2021
Estimated completion	1 October 2022

Drugs / interventions tested

• Transcranial Magnetic Stimulation (TMS)
• Placebos — full drug profile →

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Who can join

14 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
2. Clinical and Neurochemical Effects of Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis: A Study Protocol for a Randomized Clinical Trial.
   Agüera E, Caballero-Villarraso J, Feijóo M, Escribano BM, et al · · 2020 · cited 6× · PMID 32849212 · DOI 10.3389/fneur.2020.00750
3. Adult and pediatric relapsing multiple sclerosis phase II and phase III trial design and their primary end points: A systematic review.
   Hiramatsu K, Maeda H. · · 2024 · cited 1× · PMID 38708586 · DOI 10.1111/cts.13794