Status:
UNKNOWN
Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Collaborating Sponsors:
Isaac Tunez-Fiñana
Eduardo Agüera-Morales
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
14+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
It is based on the hypothesis that the application of transcranial magnetic stimulation (TMS) at 1 Hertz or 5 Hertz in patients with relapsing-remitting multiple sclerosis (RRMS) implies a neuroprotec...
Eligibility Criteria
Inclusion
- Patients diagnosed with RRMS in their inflammatory forms who have completed a 14-dose treatment with natalizumab.
- 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.
- Patients of both sexes aged between 18 and 60 years.
- EDSS: between 3.0 and 6.5 points.
- Patients who give their informed consent for participation in the clinical trial.
- 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
- Any active or chronic infection, including HIV infection, or hepatitis B or C.
- History of neoplasia (basal cell carcinoma of the skin and in situ carcinoma in remission are excluded for more than one year).
- Life expectancy severely limited by other co-morbidities.
- Endocrine disease such as diabetes, hyper or hypothyroidism.
- 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.
- Chronic obstructive pulmonary disease.
- Severe psychiatric illnesses.
- Hepatic, or renal, or cardiac dysfunction (including coronary heart disease and heart failure).
- Chronic anaemia.
- Pregnancy or risk of pregnancy (including refusal to use contraception).
- Women in breastfeeding period.
- Inability to undergo MRI scans.
- Inability to grant written informed consent.
- Taking lipid-lowering drugs and vitamin supplements.
- 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.
- Chronic alcoholism and/or abuse of drugs of abuse (sporadic or chronic).
- Metallic implants in the head.
- Cardiac pacemaker device.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04062331
Start Date
October 1 2019
End Date
October 1 2022
Last Update
August 21 2019
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