Recruiting
Early Phase 1

rTMS

Sponsor:

Northwell Health

Code:

NCT07626216

Conditions

Dystonia Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

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

Study ID

NCT07626216

Start date

Mar 4, 2026

Status verified date

May, 2026

Completion date

May, 2029

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Transcranial Magnetic Stimulation

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.

Primary outcome measure

  • Evaluating rs-fMRI Changes Following rTMS Treatment [ Time Frame: Two to four weeks. ]

Central Contacts and Locations

Central contacts

Celina B Fernandez, MS

516-562-3646cfernandez14@northwell.edu

Bruce T Volpe, MD

516-562-3384bvolpe1@northwell.edu

Locations

Northwell Health/Feinstein Institutes

Recruiting

Manhasset, New York, United States, 11030

Contacts

Celina B Fernandez, MS

516-562-3646cfernandez14@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Jun 4, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-06-04.