Nervous System Diseases
Conditions
Interventions
melatonin ingestion
Sponsors
Department of physical medicine and functional rehabilitation Habib Bourguiba University Hospital
Neurology department Habib Bourguiba University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who signed a written consent form after being informed about the purpose and experimental procedure, as well as the benefits and risks of this study Patients who are between the ages of 19 and 45. Patients with MS in its relapsing-remitting form (RR) diagnosed by a neurologist according to McDonald's criteria Patients with an EDSS strictly lower than 6, that is to say they are able to walk approximately 100 m without assistance or rest,
Exclusion criteria
Exclusion criteria: * Obesity: BMI is greater than or equal to 30.* Hospitalization for an MS relapse * Patients with MS in its progressive forms (primary and secondary). * Pregnant women (impaired embryo-fetal development in rabbits by the toxic effect of melatonin) . * Women who are breastfeeding because exogenous melatonin can pass into breast milk (which may cause the baby to absorb large amounts) * Smokers, alcoholics or those who use drugs that can alter the sleep-wake cycle. *The use of any drug that can interact with MEL such as: antidepressants, antiepileptics, antihypertensive drugs (ie, nifedipine), antiplatelet agents, anticoagulants and immunosuppressants except natalizumab (active ingredient of Tysabri®, basic treatment administered at the rate of 1 infusion per month *Taking another supplement, antioxidant substances, anti-inflammatory drugs 3 months before the study and the use of hormonal or sleeping pills, anxiolytics and hypnotics 2 weeks before the study, and during the study because of the possibility of a pharmacodynamic interaction with melatonin. *Patients with orthopedic disorders, musculoskeletal disease and history of injury in the past 12 months requiring medical care, uncorrected visual and vestibular disorders as well as psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronotype type was evaluted by caen chronotype questionnaire, level of physical activity was determined using a validated questionnaire of of RICCI and GAGNON, epidemiological data was received from each participant through an anamnesis : Age, sex, weight, height, origin, lifestyle, profession, educational level, personal history (traumatic of the lower limbs, medical, surgical, orthopedic, physiotherapeutic) and we collected clinical parameters (data related to MS) using anamnesis and medical records: the date of diagnosis of the disease, the background treatment in progress, the date of the last outbreak of the disease, the existence of motor, sensory, vescio-sphincter disorders , EDSS Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of sleep was assessed by spiegel questionnaire; cognitive functions was evaluated by two diferents versions of montreal cognitive assesment having the same reliability and consistency, attention was assessed by simple reaction time test using REACT software; fatigue was evaluated by hooper index, the muscle strength assessment was carried out by "5 x sit to stand test" for the lower limbs and by "Nine Hole Peg test" for the upper limbs. nociceptive pain was assessed by the "analog visual scale" and neuropathic pain was evaluated by the "DN4"; the bipodal postural balance was evaluated using a force platform (STAEL) in static condition with double task (mental calculation: increment of 3) with open eyes then with closed eyes before and after supplementation, before and after fatiguing) task and in dynamic condition without double task, only with open eyes, unipodal balance was assessed using a single leg support clinical test; for the fall risk assessment, we used the Four Square Step Test (FSST); to evaluate functionnal mobility and walking speed we used respectively the Timed Up and Go (TUG) and the Timed 25 foot walk | — |
Countries
Tunisia
Contacts
Public ContactSalma Sakka
Neurology department CHU Habib Bourguiba Sfax
Outcome results
None listed