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Noninvasive Brain Stimulation for Cervical Dystonia (NetworkStim)

14 de septiembre de 2026 actualizado por: 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).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

26

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Daniel T Corp, PhD
  • Número de teléfono: +393445660971
  • Correo electrónico: danieltcorp@gmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Italia
    • Roma
      • Roma, Roma, Italia, 00128
        • Reclutamiento
        • Università Campus Bio-Medico
        • Contacto:
        • Contacto:
        • Sub-Investigador:
          • Daniel T Corp, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Active cTBS
The patients of this group will receive 4 sessions of bilateral somatosensory cortex cTBS per day for 8 days
Dispositivo: 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).
Comparador falso: 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.
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Symptoms of cervical dystonia - Toronto Western Spasmodic Torticollis Rating Scale total score
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Motor evoked potentials
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fondazione Policlinico Universitario Campus Bio-Medico

Colaboradores

European Commission

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de julio de 2026

Finalización primaria (Estimado)

6 de mayo de 2028

Finalización del estudio (Estimado)

6 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

26 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de junio de 2026

Publicado por primera vez (Actual)

2 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de noviembre de 2025

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NetworkStim 270.25 CET2 cbm

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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