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Dystonia DisorderNCT07626216

Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia

A study testing Transcranial Magnetic Stimulation in people with Dystonia Disorder, run by Northwell Health at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Dystonia Disorder
What is being tested?
Transcranial Magnetic Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
4 Mar 2026to May 2029
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Heredodegenerative 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
Show all 14Show fewer
  • 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.)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Celina B Fernandez, MS contact

516-562-3646

cfernandez14@northwell.edu

Bruce T Volpe, MD contact

516-562-3384

bvolpe1@northwell.edu

United States1 site, 1 recruiting
  • Northwell Health/Feinstein Institutes

    Manhasset, New York, 11030

    Celina B Fernandez, MS, 516-562-3646, cfernandez14@northwell.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Transcranial Magnetic Stimulation
Keywords
Transcranial Magnetic Stimulation, Hyperkinetic Movement Disorder,Truncal (Axial) Dystonia, Abnormal Posture,Contractions of the chest, back,abdominal muscles
Medical subject headings
Dystonic Disorders, Dystonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Magnetic StimulationDevice

    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.

Study groups in NCT07626216
Study groupRoleWhat they receive
Active rTMS ArmExperimentalWe 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).
Receives: Device: Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluating rs-fMRI Changes Following rTMS Treatment

    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.

    Measured: Two to four weeks.

  2. Evaluating clinical change

    We will use standard scales - the Burke-Fahn-Marsden dystonia rating scale and TWSTRS - to evaluate a clinical outcome

    Measured: 6mo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start4 Mar 2026
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Pilot trial
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07626216
Sponsor's protocol ID
25-0951
Status last verified
May 2026
First submitted
29 May 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation in people with Dystonia Disorder, run by Northwell Health at 1 site in United States.

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 4 inclusion and 14 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 16 Oct 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 United States. 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. 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 Celina B Fernandez, MS (516-562-3646, cfernandez14@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluating rs-fMRI Changes Following rTMS Treatment (time frame: Two to four weeks.). The study lists 2 primary outcomes in all. 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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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