Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis
Clinical and Neurochemical Effects of Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis
1 other identifier
interventional
90
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-sclerosis
Started Oct 2019
Typical duration for phase_1 multiple-sclerosis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2019
CompletedFirst Posted
Study publicly available on registry
August 20, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedAugust 21, 2019
August 1, 2019
2 years
August 1, 2019
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Clinical activity of the disease
Expanded Disability Status Scale. Score from 0 (total absence of disability) to 10 (death due to multiple sclerosis).
up 1 year
Comprehensive clinical assessment of the disease
Multiple Sclerosis Functional Composite. It consists of three tests: Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Task. Score measured as a function of time. The higher, the worse the patient's condition.
up 1 year
Cognitive function
Brief Repeatable Battery of Neuropsychological Test. It consists of the selective reminding test, the 10/36 spatial recall test, the symbol digit modalities test, the paced auditory serial addition test and the word list generation test. A higher score means a better status in a person.
up 1 year
Secondary Outcomes (12)
Assessment of fatigue
up 1 year
Depression assessment
up 1 year
Image analysis
through study completion, an average of 1 year
Lipoperoxidation molecules
through study completion, an average of 1 year
Carbonylated proteins
through study completion, an average of 1 year
- +7 more secondary outcomes
Study Arms (3)
Placebo group
PLACEBO COMPARATORThis group will be under standard therapy (natalizumab) plus Transcranial Magnetic Stimulation (TMS) without any frequency (device doesn't running; it means, device turned off) but the same duration of sessions.
Group under TMS 1 Hertz treatment
EXPERIMENTAL1 Hertz group (1 Hertz ) will be under standard therapy (natalizumab) plus Transcranial Magnetic Stimulation (TMS) running with a frequency of 1 Hertz.
Group under TMS 5 Hertz treatment
EXPERIMENTAL5 Hertz group (5 Hertz ) will be under standard therapy (natalizumab) plus Transcranial Magnetic Stimulation (TMS) running with a frequency of 5 Hertz .
Interventions
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.
Administration of Transcranial Magnetic Stimulation at 0 Hz (the patient will be only under drug standar therapy)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maimónides Biomedical Research Institute of Córdobalead
- Isaac Tunez-Fiñanacollaborator
- Eduardo Agüera-Moralescollaborator
Related Publications (1)
Aguera E, Caballero-Villarraso J, Feijoo M, Escribano BM, Conde C, Bahamonde MC, Giraldo AI, Paz-Rojas E, Tunez I. Clinical and Neurochemical Effects of Transcranial Magnetic Stimulation (TMS) in Multiple Sclerosis: A Study Protocol for a Randomized Clinical Trial. Front Neurol. 2020 Aug 11;11:750. doi: 10.3389/fneur.2020.00750. eCollection 2020.
PMID: 32849212DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Single-blind. Investigator who applies transcranial stimulation knows the kind of treatment (placebo, TMS 1 Hertz, TMS 5 Hertz). The patients don't know the frequency (measured Hertz) which TMS is running (0 Hertz= placebo, 1 Hertz, 5 Hertz) and the device and duration of sessions are the same.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 1, 2019
First Posted
August 20, 2019
Study Start
October 1, 2019
Primary Completion
October 1, 2021
Study Completion
October 1, 2022
Last Updated
August 21, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The protocol study may be published in the last quarter of 2019. The results could be published at the end of the study (about 2022).
- Access Criteria
- Throug the website of research group https://www.imibic.org/grupo/35 or after request it (by previous e-mail from one of investigators)
To publish the protocol study and its results in Scientific Journals