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Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia

29 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

10

Fase

  • Vroege fase 1

Contacten en locaties

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Studiecontact

Studie Contact Back-up

Studie Locaties

    • New York
      • Manhasset, New York, Verenigde Staten, 11030
        • Werving
        • Northwell Health/Feinstein Institutes
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluating rs-fMRI Changes Following rTMS Treatment
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 maart 2026

Primaire voltooiing (Geschat)

1 mei 2028

Studie voltooiing (Geschat)

1 mei 2029

Studieregistratiedata

Eerst ingediend

29 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

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JA

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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