Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia

NCT07626216 | Recruiting Early Phase 1 DMC

• 1 other identifier: 25-0951
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dystonia Disorder

Keywords

Transcranial Magnetic Stimulation, Heperkinetic Movement Disorder,Truncal (Axial) Dystonia, Abnormal Posture,Contractions of the chest, back,abdominal muscles

Outcome Measures

Primary Outcomes (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.

  Two to four weeks.

Study Arms (1)

Active rTMS Arm

EXPERIMENTAL

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).

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

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.

Active rTMS Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health/Feinstein Institutes

Manhasset, New York, 11030, United States

RECRUITING

MeSH Terms

Conditions

Dystonic Disorders; Dystonia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Celina B Fernandez, MS

CONTACT

516-562-3646; cfernandez14@northwell.edu

Bruce T Volpe, MD

CONTACT

516-562-3384; bvolpe1@northwell.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Investigator

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)