Abstract
BackgroundTourette Syndrome (TS) is a neurological condition presenting chronic motor and phonic tics, and important degree of comorbidity. Considered an uncommon illness, it first becomes apparent during childhood. Current standard treatment only achieves partial control of the condition, and provokes frequent, and sometimes severe, side effects.Methods and designMain aim:To show that, with respect to placebo treatment, the combination of 0.5 mEq/Kg magnesium and 2 mg/Kg vitamin B6 reduces motor and phonic tics and incapacity in cases of exacerbated TS among children aged 7–14 years, as measured on the Yale Global Tic Severity Scale (YGTSS).Secondary aims:Assess the safety of the treatment.Describe metabolic changes revealed by PET.Measure the impact of the experimental treatment on family life.MethodologyRandomized, blinded clinical trials. Phase IV study (new proposal for treatment with magnesium and vitamin B6). Scope: children in the geographic area of the study group. Recruitment of subjects: to include patients diagnosed with TS, in accordance with DSM-IV criteria (307.23), during a period of exacerbation, and provided none of the exclusion criteria are met. Instrumentation: clinical data and the YGTSS score will be obtained at the outset of a period of exacerbation (t0). The examinations will be made after 15 (t1), 30 (t2), 60 (t3) and 90 days (t4). PET will be performed at the t0 and t4. We evaluated decrease in the overall score (t0, t1, t2, t3, t4), PET variations, and impact made by the treatment on the patient's life (Psychological General Well-Being Index).DiscussionFew clinical trials have been carried out on children with TS, but they are necessary, as current treatment possibilities are insufficient and often provoke side effects. The difficulty of dealing with an uncommon illness makes designing such a study all the more complicated. The present study seeks to overcome possible methodological problems by implementing a prior, phase II study, in order to calculate the relevant statistical parameters and to determine the safety of the proposed treatment. Providing a collateral treatment with magnesium and vitamin B6 could improve control of the illness and help reduce side effects.This protocol was approved by the Andalusian Government Committee for Clinical Trials (Spain).This study was funded by the Health Department of the Andalusian Regional Government and by the Healthcare Research Fund of the Carlos III Healthcare Institute (Spanish Ministry of Health).Trial RegistrationCurrent Controlled Trials ISRCTN41082378
Highlights
Tourette Syndrome (TS) is a neurological condition presenting chronic motor and phonic tics, and important degree of comorbidity
TS is currently considered a neurological condition with a genetic background and varying degrees of penetration, presenting chronic motor and phonic tics, sometimes accompanied by a comorbid pathology, and with a natural rhythm of remissions and exacerbations [2,3]
TS is considered to be a rare neurological illness, increasingly high rates of prevalence are being reported in current studies
Summary
Design Type of clinical trials Blind, randomized clinical study, Phase IV (new indication for supplementary magnesium and vitamin B6). Randomization to either the treatment or the placebo group will only be performed when a patient, suffering exacerbated TS, is considered eligible to receive the medication included in this study. The parents/guardians will be informed, and on receipt of their informed consent, the previously randomized medication will be provided This medication is to be taken at the patient's home, and follow-up will be performed, at the healthcare clinic, at 15(t1), 30(t2), 60(t3) and 90(t4) days. The Spanish version of the Psychological General WellBeing Index will be calculated for the parents, at the beginning and end of the study in order to assess the psychological repercussions of the treatment on family life [30,32] This scale indicates the subjective feelings and psychological well-being (or otherwise) during the past week. The safety of the treatment will be described in terms of the percentage of adverse events, and according to levels of assignation of responsibility
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