TMS for Cervical Dystonia

Overseen By Alaa Norain, MBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Anticholinergics, Benzodiazepines, Muscle relaxants

Disqualifiers: Other dystonia, Parkinsonism, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 1 day per visit

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an innovative treatment called transcranial magnetic stimulation (TMS) to determine if it can improve symptoms in people with cervical dystonia, a condition that causes neck muscles to contract uncontrollably. Researchers aim to understand how TMS affects brain activity and behavior by using brain scans and other tests. Participants will receive either active TMS or a sham (inactive) version to compare results. This trial may suit individuals diagnosed by a neurologist with cervical dystonia who have not recently received treatments like botulinum toxin injections or TMS. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications used for treating dystonia symptoms, such as anticholinergics, benzodiazepines, and muscle relaxants, at least one month before the study.

What prior data suggests that this TMS technique is safe for cervical dystonia?

Research has shown that transcranial magnetic stimulation (TMS) could be a promising treatment for cervical dystonia, though the FDA has not yet approved it for this condition. Studies have found that TMS is generally safe when safety guidelines are closely followed, including screening to reduce the risk of seizures, a possible side effect of TMS.

In earlier trials, most participants tolerated TMS well, experiencing only mild side effects like headaches or scalp discomfort. However, researchers continue to study the safety of TMS, and participants should be aware of the seizure risk, even though strict safety measures help reduce it.

Overall, TMS may help improve symptoms of cervical dystonia, and its safety is continuously assessed in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fMRI-guided individualized TMS for cervical dystonia because it offers a new, targeted approach that could improve precision and effectiveness. Unlike traditional treatments like Botox injections or oral medications, which can have systemic effects or require frequent administration, TMS targets the primary somatosensory cortex directly with magnetic pulses, potentially reducing muscle contractions without widespread side effects. This method leverages advanced imaging to tailor the treatment to each individual's brain activity, promising a more personalized and potentially more effective therapy.

What evidence suggests that fMRI-guided individualized TMS is effective for cervical dystonia?

Research has shown that transcranial magnetic stimulation (TMS) could be a promising treatment for dystonia, a movement disorder. In earlier studies, personalized TMS improved handwriting in individuals with focal hand dystonia after just one session. This trial will evaluate the effects of TMS on cervical dystonia, specifically targeting the primary somatosensory cortex in one treatment arm, while another arm will involve sham TMS as a comparator. TMS uses magnetic fields to stimulate brain cells, which may help adjust brain activity related to dystonia. Early findings indicate that TMS can change brain networks, possibly improving movement and behavior. Although still under investigation, these results offer hope for those with cervical dystonia. ^{1 2 3 4 6}

Who Is on the Research Team?

Noreen Bukhari-Parlakturk, MD PhD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like isolated focal hand dystonia, general dystonia, or torticollis. Participants should be able to attend 10 in-person visits and undergo MRI scans and behavior analysis. The study excludes those at risk of seizures or who don't meet the safety guidelines for TMS.

Inclusion Criteria

Must be able to sign an informed consent

I have been diagnosed with focal hand dystonia by a neurologist.

Must be literate

Exclusion Criteria

I have a history of seizures.

I haven't had TMS therapy for any reason in the last month.

I haven't had hand therapy in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated TMS sessions, with four sessions administered in a single day during two in-person visits.

1 day per visit

2 visits (in-person)

Assessment

Changes in brain function and behavior are evaluated using functional MRI and behavioral assays after each TMS session.

Approximately 4 weeks

7 visits (in-person)

Follow-up

Participants are monitored for changes in neck angles and brain activity post-TMS and potentially post-DBS.

Approximately 7 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• fMRI-guided Individualized TMS

Trial Overview The study tests whether four sessions of accelerated transcranial magnetic stimulation (TMS) can improve brain function and reduce symptoms in patients with focal hand dystonia. It includes fMRI brain scans before and after treatment to observe changes.

How Is the Trial Designed?

Group I: TMS to primary somatosensory cortex Active Control 1 Intervention

Participants received TMS sessions at primary somatosensory cortex

Group II: sham TMS Placebo Group 1 Intervention

Participants receive sham TMS

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

American Academy of Neurology

Collaborator

Trials

12

Recruited

370+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) significantly reduced the severity of dystonia symptoms in 66 patients, as measured by the Burke-Fahn-Marsden scale, indicating its efficacy in treating this condition.

The treatment was well-tolerated with minimal side effects, suggesting that rTMS is a safe option for patients with various forms of dystonia, supporting its broader use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of transcranial magnetic stimulation in the treatment of rare forms of muscular dystonia]. Likhachev, SA., Charnukha, TN., Zabrodzets, GV., et al.[2018]

In a study involving 8 subjects with cervical dystonia, low-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex and dorsal premotor cortex showed significant improvement in dystonia symptoms, as indicated by a decrease in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores.

The treatment was found to be safe and tolerable, suggesting that rTMS could be a promising non-invasive therapeutic option for managing cervical dystonia, warranting further investigation into its efficacy and optimal targeting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation in cervical dystonia: effect of site and repetition in a randomized pilot trial. Pirio Richardson, S., Tinaz, S., Chen, R.[2020]

In patients with dystonia who had deep brain stimulation (DBS) electrodes implanted, transcranial magnetic stimulation (TMS) of one motor cortex produced bilateral hand motor responses, indicating a complex interaction between cortical and subcortical pathways.

The study found that ipsilateral responses to TMS were smaller and faster than contralateral responses, suggesting that these responses originate from subcortical activation of corticospinal fibers, which is important for interpreting TMS results in patients with DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pseudo-bilateral hand motor responses evoked by transcranial magnetic stimulation in patients with deep brain stimulators. Kühn, AA., Trottenberg, T., Kupsch, A., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-isolated-focal-hand-dystonia-6-2024-2ec20

TMS for Cervical Dystonia · Info for Participants This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal ...

2. ctv.veeva.com ctv.veeva.com/study/fmri-guided-individualized-tms-transcranial-magnetic-stimulation-for-cervical-dystonia

Accelerating TMS for Cervical Dystonia - ClinicalTrials.Veeva This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal cervical ...

3. frontierspartnerships.org frontierspartnerships.org/journals/dystonia/articles/10.3389/dyst.2023.11660/full

Transcranial magnetic stimulation: the road to clinical therapy ... Functional MRI-guided individualized TMS modifies motor network and reduces writing dysfluency in Focal Hand Dystonia. In: Samuel Belzberg ...

4. frontierspartnerships.org frontierspartnerships.org/journals/dystonia/articles/10.3389/dyst.2025.14547/full

A narrative review: clinical trials in therapeutic interventions for ... Data extracted included history of the therapeutic intervention, study characteristics and trial methodology, primary and secondary outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X24001712

Brain metabolic response to repetitive transcranial ... Thirteen patients with cervical dystonia (CD) and 14 healthy volunteers completed the study. The subjects were first scanned using MRI to identify the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ... Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines