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NCT Number: NCT06422104

Neuromodulation Therapy for Task-Specific Dystonia

This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after active rTMS compared to sham rTMS. A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS. The study will evaluate rTMS response using measures if writing on a sensor tablet, examiner and patient dystonia rating scales and brain imaging scan (functional MRI) to understand brain changes after rTMS. Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures.

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Key information

Conditions

Isolated Focal Hand Dystonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27705, United States

About this study

The primary objective of this study is to develop rTMS for FHD. The focus is to assess whether stimulating the PMC or PSC will show greater improvement in writing behavior. This research builds upon prior studies that have demonstrated improvement in behavior after rTMS to PMC and PSC. The study includes five sequential visits:

  • Visit 1 behavior writing measures and dystonia rating scales.
  • Visit 2 includes task-based functional MRI brain scans to develop cortical target for rTMS sessions.
  • Visits 3, 4, and 5: FHD participants receive 10 Hz rTMS to PMC, PSC and sham rTMS to PMC in a cross over design with at minimum one week of washout between sessions. Participants complete behavior writing measures and rating scales on same day before and after each TMS session and an fMRI after each TMS session. Up to 5 Healthy Volunteers were recruited to help develop the TMS visits.

The information in this record reflects Visits 3-5

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Control Participants:
  • 18yrs and older
  • Left or Right hand dominance
  • Age-matched to Focal Hand dystonia patients
  • Must be able to sign informed consent
  • Must be literate
  • Focal Hand dystonia Patients:
  • 18yrs and older
  • Left or Right hand dominance
  • Diagnosed with Writer's Cramp dystonia in left or right hand
  • Must be able to sign informed consent
  • Must be literate

Exclusion criteria

Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5):

  • Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
  • Botulinum toxin injections within 3 months of research study
  • Medications with effects on the central nervous system including anticholinergic, benzodiazepines, and muscle relaxants among others within 1 week of the study
  • No physical or occupational therapy of the upper extremities
  • Any contraindications to MRI (ie: metal in body or implanted medical devices, etc)
  • Any contraindication on TMS adult safety screening (TASS form) including seizure history, pregnancy, brain injury, cranial metal implants, known structural brain lesion

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session

Primary outcomes

  1. Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions

    Time frame: Pre-TMS and post-TMS session (each session is approximately 45 minutes)

Secondary outcomes

  1. Safety, as Measured by TMS Acute Side Effects

    Time frame: During TMS session (each session is approximately 45 minutes)

  2. Change in Peak Accelerations Behavior (Calculated by Taking the Change in Peak Accelerations From Behavior Performed Before and After Each TMS Visit).

    Time frame: Pre-TMS and post-TMS session (each session is approximately 45 minutes)

    Change in peak accelerations behaviors pre- and post-TMS is calculated by taking the change in peak accelerations from behavior performed before and after each TMS visit. Higher measures of peak accelerations represent greater writing dysfluency and worsening dystonia.

  3. Brain Connectivity Between Superior Parietal Cortex to Right Cerebellum VIII

    Time frame: Post-TMS session (each session is approximately 45 minutes)

    Brain connectivity was assessed using functional magnetic resonance imaging of the brain. The z-score is mathematical calculation of the synchronization between brain regions. Specifically, functional connectivity z-scores quantify the strength of synchronization between brain regions by transforming Pearson correlation coefficients (r-values) into normally distributed values (z-scores). This Fisher-z transformation stabilizes variance, enabling valid group-level statistical comparisons (e.g., t-tests) of functional connectivity. Positive Z-scores (Z scores> 0) represent stronger synchronization between brain regions and strengthening of connectivity between brain regions; negative Z-scores (Z-scores <0) indicate anti-synchronization between brain regions and weakening of connectivity between brain regions.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Doris Duke Charitable Foundation
  • Dystonia Coalition
  • Dystonia Study Group
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Development of Mechanistically Informed Therapy for Task-Specific Dystonia Using Noninvasive Neuromodulation

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 20, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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