10 Participants NeededMy employer runs this trial

Transcranial Magnetic Stimulation for Dystonia

CB
BT
Overseen ByBruce T Volpe, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how repetitive transcranial magnetic stimulation (rTMS) affects brain activity in individuals with dystonia, a condition causing involuntary muscle movements. The researchers aim to assess changes in brain connectivity using brain scans. This trial suits those with dystonia affecting the head, neck, trunk, or limbs, who have not experienced certain medical conditions like stroke or Parkinson’s. As an Early Phase 1 trial, this research focuses on understanding how rTMS works in people, offering a unique opportunity to be among the first to explore its effects.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that long-term use of benzodiazepines, neuroleptics, or anticonvulsants is not allowed. Also, you cannot have had botulinum toxin within 12 weeks before the trial starts.

What prior data suggests that this technique is safe for individuals with dystonia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and well-tolerated. One study found the treatment safe for most patients, with no major health changes over time. Another study highlighted that rTMS can stimulate the brain without harm and does not require surgery. Although the FDA has not yet approved rTMS for treating dystonia specifically, it has been researched for other conditions and has shown promise without serious side effects. Overall, past research suggests that rTMS is a safe option for many people.12345

Why do researchers think this study treatment might be promising for dystonia?

Most treatments for dystonia, such as botulinum toxin injections and oral medications, focus on managing symptoms by relaxing muscles or altering brain chemicals. However, repetitive Transcranial Magnetic Stimulation (rTMS) offers a unique approach by non-invasively targeting and modulating brain networks involved in movement control. Researchers are excited because rTMS could potentially rewire brain pathways and offer lasting relief without the side effects typically associated with conventional medications. This innovative method provides a new hope for improving quality of life in dystonia patients by addressing the root cause rather than just alleviating symptoms.

What evidence suggests that repetitive transcranial magnetic stimulation (rTMS) might be an effective treatment for dystonia?

Studies have shown that repetitive transcranial magnetic stimulation (rTMS) might help treat dystonia, a movement disorder. One study demonstrated significant improvement in patients with secondary dystonia after receiving low-frequency rTMS on the premotor cortex. Another study found that 10 sessions of active rTMS were more effective than a single session in improving symptoms. Although the FDA has not yet approved rTMS for dystonia, some research suggests it can reduce muscle spasms and pain in patients with secondary generalized dystonia. However, results can vary, and more research is needed to fully understand its potential. Participants in this trial will receive active rTMS to investigate its effects on brain networks in patients with dystonia.12678

Are You a Good Fit for This Trial?

This trial is for people diagnosed with focal dystonia, a movement disorder causing involuntary muscle contractions. Specific inclusion and exclusion criteria are not listed, so eligibility may depend on further screening by the study team.

Inclusion Criteria

I am male or female.
I am between 18 and 80 years old.
I have ongoing involuntary movements in my head, neck, trunk, or limbs.
See 1 more

Exclusion Criteria

Past psychiatric conditions such as depression
My blood pressure is higher than 160/90 mmHg.
I have diabetes.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repetitive transcranial magnetic stimulation (rTMS) to modulate abnormal cortical regions

2-4 weeks
Multiple sessions per week

Follow-up

Participants are monitored for changes in brain networks using rs-fMRI after rTMS treatment

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

The study tests repetitive transcranial magnetic stimulation (rTMS), a non-invasive procedure that uses magnetic fields to stimulate brain activity, to see how it affects brain connectivity in people with dystonia using fMRI scans.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Active rTMS ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Citations

Repetitive Transcranial Magnetic Stimulation in Cervical ...

In one pilot study, patients with secondary dystonia received low-frequency rTMS over the premotor cortex and showed significant improvement in ...

Effects of non-invasive brain stimulation in dystonia

Meta-regression analysis demonstrated that 10 sessions of active stimulation was more effective for improving dystonia symptoms than one or ...

Transcranial magnetic stimulation: the road to clinical therapy ...

Despite many research studies, transcranial magnetic stimulation (TMS) is not yet an FDA-approved clinical therapy for dystonia patients.

Brain metabolic response to repetitive transcranial ...

The remote activation was positively associated with dystonia severity and efficacy of sensory trick phenomenon in CD patients.

Clinical Research - Brain Stimulation

Results: According to CDQ24 was found a decrease of average score after TMS-treatment course (58.4±10.8 vs 51.3±12.4) (p<0.05). Significant changes in subscale ...

Study Details | NCT07173920 | Single-Center, Double- ...

TD causes irreversible neurological damage that persists even after discontinuing the causative drugs, significantly impairing patients' functional outcomes. ...

Contribution of TMS and rTMS in the Understanding ...

High or low frequency repetitive TMS (rTMS) can induce excitatory or inhibitory lasting effects ・ prevention of cell death, as a safe and non-invasive ...

Effects of low-frequency repetitive transcranial magnetic ...

This pilot and feasibility study aimed to examine the safety, feasibility, and effects of a single session 1 Hz rTMS over the laryngeal motor ...