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Enrolling by invitationPhase 2

Accelerating TMS for Cervical Dystonia

Key facts

Who runs it
Duke University
Where
Durham, United StatesSee the site
Trial code
Status
Enrolling by invitation
Phase
Phase 2
People taking part
50 people, planned
Started
17 Dec 2024
Expected to end
1 Jul 2029
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Transcranial Magnetic Stimulation (TMS)
  • Placebo
  • trihexyphenidyl 10mg
Record updated
5 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 18yrs and older
  • Diagnosed with isolated cervical dystonia by Neurologist
  • Must be able to sign an informed consent
  • Must be literate
  • 18yrs and older
  • diagnosed with cervical dystonia by a Neurologist
  • must be able to sign informed consent
  • must be literate
  • On no medications or one medication to treat symptoms of dystonia for a minimum of one month prior to study participation

Who cannot take part

  • Concomitant medications known to decrease seizure threshold
  • Illicit drug use
  • No TMS therapy for another indication within one month of this research study
  • Medications used for symptom treatment of dystonia including anticholinergic, benzodiazepines, and muscle relaxants among others within one month of the study
  • No physical or occupational therapy of the neck within one month of the study
  • More than two medications used for symptom treatment of dystonia including anticholinergic, benzodiazepines, and muscle relaxants among others within one month of the study
  • Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
  • History of seizure disorder
  • other neurological movement disorders diagnoses including Parkinsonism, or essential tremor
  • a history of seizures and anti-seizure medications by review of medical records
  • Botulinum toxin injections within 3 months of the research study
  • Any contraindications to MRI or TMS
  • botulinum toxin injections within 3 months of research study
  • contraindications to MRI or TMS

Where in United States

  • Duke University Health SystemDurham, United StatesNo longer taking part

About the trial

What the trial wants to find out

This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal cervical dystonia. Previous research demonstrated that individualized TMS improved writing behavior in focal hand dystonia after one session. In this study, we aim to expand the application on TMS on focal cervical dystonia. The current study administers six sessions of TMS separated by five rest blocks, all in a single day and combined with a medication called trihexyphenidyl given 30 minutes before the TMS session. This approach is called "anticholinergic enhanced accelerated TMS The research involves 8 in-person visits and 3 remote visits over 28 weeks. The effect of TMS will be assessed using functional MRI brain scans and behavioral measurements. Participants who are interested in enrolling in the TMS study to assess their potential presurgical response to DBS will only receive the active TMS session combined with trihexyphenidyl medication. After active TMS + trihexyphenidyl medication, participants will be followed for 3-5months to assess their brain and behavior response to TMS. Following clinical care DBS, participants will be followed for three additional research visits. The three visits will be performed at 1 month, 3 months and 6-9 months. During the post-DBS research visits, participants will complete behavioral assay and physiological assay to evaluate their neck movements and muscles. At 3 month or 6-9 month visit, the post-DBS participants will also undergo fMRI with the DBS device in off mode setting.

Read full original descriptionShow less

The risk of TMS includes seizures; the potential risk of seizures from TMS is mitigated through careful screening, adhering to safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the understanding of brain changes caused by TMS in cervical dystonia, paving the way for further advancements in clinical therapy for this condition.

The 3 groups in the trial

  • sham TMSSham treatment, for comparison

    Participants receive sham TMS

    Treatment: Transcranial Magnetic Stimulation (TMS) and Placebo

  • TMS to primary somatosensory cortexExisting treatment, for comparison

    Participants received TMS sessions at primary somatosensory cortex

    Treatment: Transcranial Magnetic Stimulation (TMS) and trihexyphenidyl 10mg

  • TMS to primary somatosensory cortex (Open Label DBS Participants)Existing treatment, for comparison

    Participants received TMS sessions at primary somatosensory cortex

    Treatment: trihexyphenidyl 10mg

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Functional Magnetic Resonance Imaging (fMRI)-Guided Individualized Transcranial Magnetic Stimulation (TMS) for Cervical Dystonia
Record updated
5 November 2026