Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Eduardo Agüera-Morales; Isaac Tunez-Fiñana

Criteria

Inclusion Criteria:

1. Patients diagnosed with RRMS in their inflammatory forms who have completed a 14-dose treatment with natalizumab.

2. Normal analytical parameters, defined by: Leukocytes> 3000 / mcl, Neutrophils> 1500 / mcl, Platelets> 100000 / mcl, AST/ALT <2.5 IU / L, Creatinine <2.5 mg / dl.

3. Patients of both sexes aged between 18 and 60 years.

4. EDSS: between 3.0 and 6.5 points.

5. Patients who give their informed consent for participation in the clinical trial.

6. Women of childbearing potential must obtain negative results in a pregnancy test performed at the time of inclusion in the study and commit to using a medically approved method of contraception for the duration of the study.

Exclusion Criteria:

1. Any active or chronic infection, including HIV infection, or hepatitis B or C.

2. History of neoplasia (basal cell carcinoma of the skin and in situ carcinoma in remission are excluded for more than one year).

3. Life expectancy severely limited by other co-morbidities.

4. Endocrine disease such as diabetes, hyper or hypothyroidism.

5. Chronic inflammatory or autoimmune disease such as ulcerative colitis, Crohn's disease, systemic lupus erythematosus and any other form of connective tissue disease or chronic arthropathy.

6. Chronic obstructive pulmonary disease.

7. Severe psychiatric illnesses.

8. Hepatic, or renal, or cardiac dysfunction (including coronary heart disease and heart failure).

9. Chronic anaemia.

10. Pregnancy or risk of pregnancy (including refusal to use contraception).

11. Women in breastfeeding period.

12. Inability to undergo MRI scans.

13. Inability to grant written informed consent.

14. Taking lipid-lowering drugs and vitamin supplements.

15. Treatment with steroids and/or non-steroidal anti-inflammatories, or alcohol intake 40 hours before the blood extraction and/or development of the different tests.

16. Chronic alcoholism and/or abuse of drugs of abuse (sporadic or chronic).

17. Metallic implants in the head.

18. Cardiac pacemaker device.