Cervical DystoniaNetworkStimNCT07681284
Noninvasive Brain Stimulation for Cervical Dystonia
A study testing Active continuous theta-burst stimulation in people with Cervical Dystonia, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Active continuous theta-burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jul 2026to 6 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università Campus Bio-Medico
Roma, Roma, 00128
Vincenzo Di Lazzaro, MD, +39 06225411220, v.dilazzaro@policlinicocampus.it
Ambra Salvati, Psy.D., +39 3491028595, ambra.salvati@unicampus.it
About this study
Official title: 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).
Read the detailed description
Cervical dystonia (CD) is the most common form of dystonia and is characterised by excessive and involuntary muscle contractions of the muscles in the neck. Whilst botulinum neurotoxin (BoNT) injections to the affected muscles can provide therapeutic relief to CD patients, up to one-third of patients report an inadequate response to treatment. In more severe cases, deep brain stimulation (DBS) of the globus pallidus interna (GPi) or subthalamic nucleus is an effective treatment for CD symptoms, directly and indirectly modulating networks thought to be abnormal in CD. Transcranial magnetic stimulation (TMS) trials have previously been conducted to investigate its potential to ameliorate CD symptoms. These studies have shown limited success, with small sample sizes, and variable results. A major factor limiting the more effective use of TMS in CD is that it is not yet known where to target with TMS, given the many structures implicated in the neurobiology of the disorder. A prior study using lesion network mapping in CD attempted to address this issue by localising a brain network connected to lesions causing CD. Corp, et al. demonstrated that although causal lesions were located throughout the brain, all lesions were functionally connected to a brain network involving positive connectivity to the cerebellum and negative connectivity to the somatosensory cortex (S1). Preliminary work from our group examined the effect of targeting this lesion network mapping-derived S1 cluster using TMS. First, a single session of continuous theta-burst stimulation (cTBS) to the S1 indicated target engagement, as demonstrated by abnormal metabolic response in CD patients, and next, a pilot trial of 10 days of daily cTBS demonstrated a 12% reduction in CD symptoms. The primary aim of this study is to assess whether a higher-dose of (4x daily) cTBS can increase therapeutic effect.
- Conditions
- Cervical Dystonia
- Being tested
- Active continuous theta-burst stimulation, Sham continuous theta-burst stimulation
- Keywords
- Cervical dystonia, Transcranial magnetic stimulation, Somatosensory cortex, Continuous theta-burst stimulation
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active continuous theta-burst stimulationDevice
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 stimulationDevice
Sham cTBS procedures will be identical to those in the active cTBS arm but applied using a 70mm sham TMS coil.
| Study group | Role | What they receive |
|---|---|---|
| Active cTBS | Experimental | The patients of this group will receive 4 sessions of bilateral somatosensory cortex cTBS per day for 8 days Receives: Device: Active continuous theta-burst stimulation |
| Sham cTBS | Sham comparator | 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. Receives: Device: Sham continuous theta-burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Secondary outcomes (6)
Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale subscales
The scores on each of the subscales of the Toronto Western Spasmodic Torticollis Rating Scale (severity, disability, pain). Higher scores mean worse symptoms.
Measured: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Symptoms of cervical dystonia - kinematic recordings
Metrics of patients' head and neck movements from a wearable motion sensor. Higher scores will mean greater movement error.
Measured: For a single patient, 10 days. Pre and post cTBS
Motor evoked potentials
Motor evoked potential amplitudes from input-output curves, measured using surface electromyography
Measured: For a single patient, 10 days. Pre and post cTBS
Magnetic resonance imaging
Functional connectivity changes from pre-defined regions of interest in the brain
Measured: For a single patient, 10 days. Pre and post cTBS
Fahn Tolosa Marin tremor scale
Measurement of head and neck tremor. Higher scores mean worse symptoms.
Measured: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Global dystonia severity rating scale
Measurement of dystonia in all body parts. Range: 0-100. Higher scores mean worse symptoms.
Measured: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start6 Jul 2026
- Primary completion6 May 2028 (estimated)
- Study completion6 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Vincenzo Di Lazzaro, MD, Principal investigator, Campus Bio-Medico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681284
- Sponsor's protocol ID
- NetworkStim 270.25 CET2 cbm
- Acronym
- NetworkStim
- Status last verified
- Nov 2025
- First submitted
- 26 Jun 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Noninvasive Brain Stimulation on Symptoms of Cervical Dystonia
- ClinicalTrials.gov ID
- NCT07681284
- Acronym / sponsor ID
- NetworkStim / NetworkStim 270.25 CET2 cbm
- Conditions
- Cervical Dystonia
- Keywords
- Cervical dystonia, Transcranial magnetic stimulation, Somatosensory cortex, Continuous theta-burst stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 6 May 2028 (estimated)
- Study completion
- 6 May 2028 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Cervical dystonia (CD) is the most common form of dystonia and is characterised by excessive and involuntary muscle contractions of the muscles in the neck. Whilst botulinum neurotoxin (BoNT) injections to the affected muscles can provide therapeutic relief to CD patients, up to one-third of patients report an inadequate response to treatment. In more severe cases, deep brain stimulation (DBS) of the globus pallidus interna (GPi) or subthalamic nucleus is an effective treatment for CD symptoms, directly and indirectly modulating networks thought to be abnormal in CD. Transcranial magnetic stimulation (TMS) trials have previously been conducted to investigate its potential to ameliorate CD symptoms. These studies have shown limited success, with small sample sizes, and variable results. A major factor limiting the more effective use of TMS in CD is that it is not yet known where to target with TMS, given the many structures implicated in the neurobiology of the disorder. A prior study using lesion network mapping in CD attempted to address this issue by localising a brain network connected to lesions causing CD. Corp, et al. demonstrated that although causal lesions were located throughout the brain, all lesions were functionally connected to a brain network involving positive connectivity to the cerebellum and negative connectivity to the somatosensory cortex (S1). Preliminary work from our group examined the effect of targeting this lesion network mapping-derived S1 cluster using TMS. First, a single session of continuous theta-burst stimulation (cTBS) to the S1 indicated target engagement, as demonstrated by abnormal metabolic response in CD patients, and next, a pilot trial of 10 days of daily cTBS demonstrated a 12% reduction in CD symptoms. The primary aim of this study is to assess whether a higher-dose of (4x daily) cTBS can increase therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cTBS | Experimental | Device: Active continuous theta-burst stimulationThe patients of this group will receive 4 sessions of bilateral somatosensory cortex cTBS per day for 8 days |
| Sham cTBS | Sham comparator | Device: Sham continuous theta-burst stimulationThe patients of this group will receive 4 sessions of bilateral somatosensory cortex cTBS per day for 8 days, delivered using a sham TMS coil. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active continuous theta-burst stimulationContinuous 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). | Device | Active cTBS |
| Sham continuous theta-burst stimulationSham cTBS procedures will be identical to those in the active cTBS arm but applied using a 70mm sham TMS coil. | Device | Sham cTBS |
Primary outcome
Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale total score
Time frame: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
The total score on the Toronto Western Spasmodic Torticollis Rating Scale. Range: 0-85. Higher scores mean worse symptoms.
6 secondary outcomes
Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale subscales
Time frame: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Symptoms of cervical dystonia - kinematic recordings
Time frame: For a single patient, 10 days. Pre and post cTBS
Motor evoked potentials
Time frame: For a single patient, 10 days. Pre and post cTBS
Magnetic resonance imaging
Time frame: For a single patient, 10 days. Pre and post cTBS
Fahn Tolosa Marin tremor scale
Time frame: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Global dystonia severity rating scale
Time frame: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincenzo Di Lazzaro, MD principal investigator
Campus Bio-Medico Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active continuous theta-burst stimulation in people with Cervical Dystonia, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel T Corp, PhD (+393445660971, danieltcorp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale total score (time frame: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.