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Noninvasive Brain Stimulation for Cervical Dystonia

Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico • ClinicalTrials.gov ID: NCT07681284

Registry updated: 2026-09-17

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Description

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).

Interventions

Active continuous theta-burst stimulation (Device)
Continuous theta-burst stimulation (cTBS) will be delivered using a Magstim Rapid machine connected to a 70mm cooled coil at 80% of a participants resting motor threshold (RMT). cTBS will consist of three-pulse bursts at 50Hz repeated every 200ms (5Hz) for 40 seconds (600 pulses total) (Huang, Edwards et al. 2005). All cTBS procedures will be conducted bilaterally, with application first over the left hemisphere, before moving to the right (approximately one minute will separate each hemisphere). Bilateral cTBS will be delivered four times daily, over eight days, for a total of 32 bilateral cTBS sessions. This 4x day protocol will follow prior studies in neglect patients, delivered at time intervals of 0, 15, 60, and 75 minutes (Nyffeler, Cazzoli et al. 2008, Cazzoli, Müri et al. 2012, Nyffeler, Vanbellingen et al. 2019).
Sham continuous theta-burst stimulation (Device)
Sham cTBS procedures will be identical to those in the active cTBS arm but applied using a 70mm sham TMS coil.

Eligibility criteria

Inclusion Criteria * 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) Exclusion Criteria * 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) * Other contraindications for TMS or brain MRI (e.g., metal in the head) * Pregnant or breastfeeding women * History of substance abuse or dependence

Conditions

Cervical Dystonia

Locations

Università Campus Bio-Medico — Roma, Roma, Italy

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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