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Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia

29 de maio de 2026 atualizado por: Bruce Volpe, Northwell Health

The Effect of Repetitive Trans-cranial Magnetic (rTMS) Stimulation on Abnormal Cortical Hubs Identified by Functional Magnetic Resonance in Subjects With Dystonia.

By tracking resting-state fMRI scans, we aim to discover how repetitive transcranial magnetic stimulation (rTMS) changes brain connectivity in individuals with dystonia.

Visão geral do estudo

Status

Recrutamento

Descrição detalhada

Dystonia is a neurological movement disorder characterized by spontaneous involuntary muscle contractions that cause repetitive twisting motions. These involuntary movements affect various body regions, including the face (blepharospasm), jaw (bruxism, oromandibular dystonia), head and neck (torticollis), voice box (laryngeal spasm), hands (writer's cramp), or as multiple body segments simultaneously. Dystonia lacks defining neuropathological change, making diagnosis challenging, and rendering symptom management incomplete. Advanced imaging techniques, particularly spatial covariance analysis and graph theory computations have revealed insights into dystonia's underlying brain networks. This approach shows that the relative strength of the metabolic function at each brain region (called "hubs") regulates information flow within the network and between the network and the rest of the brain. The identification of accessible cortical hubs as integral parts of the dystonia network raises new therapeutic possibilities though non-invasive techniques. Continuous theta-burst stimulation (cTBS), a modified form of rTMS that mimics natural brain rhythms (theta 4-8Hz), can effectively inhibit the cortical hyperactivity in targeted hubs with shorter treatment times than traditional approaches. The rationale for this proposed pilot experiment is to combine advanced analysis of standard neuroimaging to refine target location for a test of whether the application of non-invasive rTMS (in the form of cTBS) modulates abnormal cortical regions or the entire brain network, or both, as these networks underlie dystonia.

Our PET investigations of patients with dystonia (DYT1 carriers both symptomatic and non-symptomatic) have identified hyperactive subcortical regions including the lentiform nuclei, cerebellum, and supplementary motor cortex. The dystonia-related brain metabolic networks that we generated with PET scanning, can now be generated with rs-fMRI, a less invasive technique that avoids radiation exposure and blood sampling. Graph Theory analysis indicates that the bilateral motor cortex (spanning the inter-hemispheric sulcus) and the left pre-motor region serve as critical hyperactive hubs. We hypothesize that modulating these hubs will disrupt the information flow in patients with dystonia. Using frameless stereotaxic optical system (Polaris Vicra, BrainSight 2.2), we can precisely target these cortical hubs with cTBS, the inhibitory form of rTMS.

We are encouraged by recent studies that showed that a single cTBS run (40sec) precisely targeted significantly modified brain networks in patients with dystonia.

Ameliorating dystonia has been one of the most controversial and challenging topics in treating hyperkinetic movement disorders, because it is difficult to estimate the overall whole brain responses after focal alterations caused by brain stimulation techniques. Our approach offers several innovations:

  1. Enhanced and personalized hypermetabolic cortical hub identification.
  2. Use of independent component analysis and graph theory to optimize location for cTBS delivery.
  3. Individual response to the single cTBS stimulation site will be used for customized modeling of the TMS effect.

Although previous attempts to use TMS to improve dystonia have been inconsistent, our precisely targeted approach may improve outcomes. Success with this method could expand TMS application beyond its established use in depression to other neurological disorders. The shift from PET to rs-fMRI for network mapping represents a significant advance, making the technique/treatment more accessible and easier on patients.

Tipo de estudo

Intervencional

Inscrição (Estimado)

10

Estágio

  • Fase inicial 1

Contactos e Locais

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Contato de estudo

Estude backup de contato

Locais de estudo

    • New York
      • Manhasset, New York, Estados Unidos, 11030
        • Recrutamento
        • Northwell Health/Feinstein Institutes
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Male or female
  • 18 and 80 years of age.
  • Patients who manifest dystonia - sustained involuntary movement of the head, neck, trunk or limbs.
  • The dystonia may be spontaneous or genetic, specifically DYT1 or DYT6 and then only those patients who are demonstrating dystonia. The patient/subject will have a normal neurological exam except for dystonia.

Exclusion Criteria:

  • Heredodegenrative dystonia of the type DYT8,9 or 10.
  • Past history of head trauma, stroke, epilepsy, demyelinating disease
  • Hypertension in excess of 160mmHg systolic and 90mmHg diastolic
  • Congestive heart failure
  • Diabetes
  • Past psychiatric conditions: e.g., depression
  • Systemic metabolic disease: e.g., Wilson's disease, progressive neurodegenerative disease (like supranuclear palsy or corticobasal ganglionic degeneration)
  • Magnetizable incorporated metal parts - like pacemakers
  • History or diagnosis of Parkinson's disease
  • Presence of myoclonus
  • No previous surgery for dystonia
  • Long term exposure to benzodiazepines, neuroleptics or anticonvulsants
  • No botulinum toxin within 12 weeks of baseline assessment and fMRI.
  • Moderate to severe cognitive impairment (judged by a minimental status of <24.)

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Active rTMS Arm
We will investigate how repetitive transcranial magnetic stimulation (rTMS) affects brain networks in patients with dystonia by measuring changes in resting state-functional magnetic resonance images (rs-fMRI).
Continuous theta-burst stimulation (cTBS), a modified form of rTMS that mimics natural brain rhythms (theta 4-8Hz), can effectively inhibit the cortical hyperactivity in targeted hubs with shorter treatment times than traditional approaches. The rationale for this proposed pilot experiment is to combine advanced analysis of standard neuroimaging to refine target location for a test of whether the application of non-invasive rTMS (in the form of cTBS) modulates abnormal cortical regions or the entire brain network, or both, as these networks underlie dystonia. This pilot study will provide the basis for a controlled study to test the effectiveness and robustness of any positive influence that TMS might have on the patients' dystonia.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Evaluating rs-fMRI Changes Following rTMS Treatment
Prazo: Two to four weeks.
The primary objective is to identify and modify replicable brain networks in dystonia patients using rs-fMRI. These networks reflect underlying disease processes, clinical symptomatology or both. The primary endpoint is change in the rs-fMRI derived network after rTMS treatment for two or four weeks, or both. We expect there to be changes at two and four weeks. We will then analyze the robustness of these changes in the repeat fMRI one week after treatment ends. Initially, identification and validation of the dystonia pattern from the resting state MRI will occur; it is a task with which we are familiar and is detailed in our recent manuscript.
Two to four weeks.

Colaboradores e Investigadores

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Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de março de 2026

Conclusão Primária (Estimado)

1 de maio de 2028

Conclusão do estudo (Estimado)

1 de maio de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

29 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de maio de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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