Noninvasive Brain Stimulation for Cervical Dystonia
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- 18 és 85 év között vagy?
Forrás: NCT07681284: ki vehet részt
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Fondazione Policlinico Universitario Campus Bio-Medico
- Azonosító
- NCT07681284
- A regiszteradat frissítve
- 2026. szeptember 17.
- Eredeti leírás
The primary aim of this study is to assess whether continuous theta-burst stimulation (cTBS) can be helpful in reducing symptoms of idiopathic cervical dystonia. This will be a parallel-group, randomised, sham-controlled, double blind clinical trial. Patients and investigators measuring patient symptoms clinical scales will be blinded from allocation group, investigators delivering the intervention will not be blinded, as this is not feasible. Real cTBS will be compared to sham cTBS, with patients allocated to these two groups with a 1:1 recruitment ratio.A teljes eredeti leírásKevesebb
The Effect of Noninvasive Brain Stimulation on Symptoms of Cervical Dystonia
The primary aim of this study is to assess whether continuous theta-burst stimulation (cTBS) can be helpful in reducing symptoms of idiopathic cervical dystonia. This will be a parallel-group, randomised, sham-controlled, double blind clinical trial. Patients and investigators measuring patient symptoms clinical scales will be blinded from allocation group, investigators delivering the intervention will not be blinded, as this is not feasible. Real cTBS will be compared to sham cTBS, with patients allocated to these two groups with a 1:1 recruitment ratio.
Bilateral cTBS will be delivered four times daily, over eight days, for a total of 32 bilateral cTBS sessions. The primary outcome is the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). This will be administered at T1 (pre-cTBS), T2 (day 10, following days 2-9 where patients received the intervention), T3 (2 weeks post the final session of cTBS), and T4 (4-5 weeks post the final session of cTBS).
Secondary outcomes will be the TWSTRS subscales (severity, disability, pain), Quality of Life scale, Global dystonia severity rating scale (GDS), Fahn Tolosa Marin (FTM) modified (to include only questions relevant to head/neck tremor) tremor scale, kinematic data of patient's movement patterns, motor evoked potentials (MEPs), and resting-state fMRI data (fMRI).
Bevonási feltételek: Aged between 18 and 85 years; Diagnosis of idiopathic cervical dystonia made by an expert physician; Last botulinum toxin injection administered at least two months before the start of participation in the study (Albanese, Abbruzzese et al. 2015).
Kizáró feltételek: Head or neck trauma occurring less than 12 months before the onset of dystonia; Acquired dystonia (e.g., drug-induced, brain lesions or trauma); History of major psychiatric disorders (e.g., bipolar disorder, schizophrenia, obsessive-compulsive disorder); History of neurological diseases other than CD (e.g., epilepsy, Parkinson's disease); History of substance abuse or dependence; Other contraindications for TMS or brain MRI (e.g., metal in the head); Pregnant or breastfeeding women.