NCT07681284|Recruiting
Noninvasive Brain Stimulation for Cervical Dystonia
NetworkStim
The Effect of Noninvasive Brain Stimulation on Symptoms of Cervical Dystonia
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NetworkStim
The Effect of Noninvasive Brain Stimulation on Symptoms of Cervical Dystonia
Sponsor study identifier
interventional
26
1 country
1
Study Start
July 6, 2026
Actual (reported)Primary Completion
May 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 26, 2026
Actual (reported)July 2, 2026
Actual (reported)July 6, 2026
Actual (reported)May 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale total score
The total score on the Toronto Western Spasmodic Torticollis Rating Scale. Range: 0-85. Higher scores mean worse symptoms.
For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale subscales
For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Symptoms of cervical dystonia - kinematic recordings
For a single patient, 10 days. Pre and post cTBS
Motor evoked potentials
For a single patient, 10 days. Pre and post cTBS
Magnetic resonance imaging
For a single patient, 10 days. Pre and post cTBS
Fahn Tolosa Marin tremor scale
For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
The patients of this group will receive 4 sessions of bilateral somatosensory cortex cTBS per day for 8 days
The patients of this group will receive 4 sessions of bilateral somatosensory cortex cTBS per day for 8 days, delivered using a sham TMS coil.
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).
Università Campus Bio-Medico
Roma, Roma, 00128, Italy
Vincenzo Di Lazzaro, MD
Campus Bio-Medico Hospital
First Submitted
June 26, 2026
First Posted
July 2, 2026
Study Start
July 6, 2026
Actual (reported)Primary Completion
Sham cTBS procedures will be identical to those in the active cTBS arm but applied using a 70mm sham TMS coil.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
May 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 17, 2026
Record last verified: 2025-11
For patients who provide informed consent: pseudonymised MRI data will be uploaded to the 'OpenNeuro' repository, and pseudonymised brain stimulation data and code will be uploaded to the 'Big NIBS data' repository, with the associated clinical scores
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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