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Noninvasive Brain Stimulation for Cervical Dystonia (NetworkStim)

14 september 2026 uppdaterad av: Fondazione Policlinico Universitario Campus Bio-Medico

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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

26

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Active cTBS
The patients of this group will receive 4 sessions of bilateral somatosensory cortex cTBS per day for 8 days
Enhet: Active continuous theta-burst stimulation
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 Comparator: Sham cTBS
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.
Enhet: Sham continuous theta-burst stimulation
Sham cTBS procedures will be identical to those in the active cTBS arm but applied using a 70mm sham TMS coil.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale total score
Tidsram: 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.
For a single patient, a minimum of 6 weeks and a maximum of 16 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Motor evoked potentials
Tidsram: For a single patient, 10 days. Pre and post cTBS
Motor evoked potential amplitudes from input-output curves, measured using surface electromyography
For a single patient, 10 days. Pre and post cTBS
Magnetic resonance imaging
Tidsram: For a single patient, 10 days. Pre and post cTBS
Functional connectivity changes from pre-defined regions of interest in the brain
For a single patient, 10 days. Pre and post cTBS
Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale subscales
Tidsram: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
The scores on each of the subscales of the Toronto Western Spasmodic Torticollis Rating Scale (severity, disability, pain). Higher scores mean worse symptoms.
For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Symptoms of cervical dystonia - kinematic recordings
Tidsram: For a single patient, 10 days. Pre and post cTBS
Metrics of patients' head and neck movements from a wearable motion sensor. Higher scores will mean greater movement error.
For a single patient, 10 days. Pre and post cTBS
Fahn Tolosa Marin tremor scale
Tidsram: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Measurement of head and neck tremor. Higher scores mean worse symptoms.
For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Global dystonia severity rating scale
Tidsram: For a single patient, a minimum of 6 weeks and a maximum of 16 weeks
Measurement of dystonia in all body parts. Range: 0-100. Higher scores mean worse symptoms.
For a single patient, a minimum of 6 weeks and a maximum of 16 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Samarbetspartners

European Commission

Utredare

  • Huvudutredare: Vincenzo Di Lazzaro, MD, Campus Bio-Medico Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 juli 2026

Primärt slutförande (Beräknad)

6 maj 2028

Avslutad studie (Beräknad)

6 maj 2028

Studieregistreringsdatum

Först inskickad

26 juni 2026

Först inskickad som uppfyllde QC-kriterierna

26 juni 2026

Första postat (Faktisk)

2 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2026

Senast verifierad

1 november 2025

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NetworkStim 270.25 CET2 cbm

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

The Study Protocol, SAP, and ICF will be made available with this pre-registration prior to study commencement. Generated participant data and code will be available after the pre-print of the publication describing it are released. There is no time limit for how long the data will be made available.

Kriterier för IPD Sharing Access

Public access as per the terms of clinicaltrials.gov and the OpenNeuro and Big NIBS data repositories.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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