Neuromodulation Therapy for Task-Specific Dystonia

March 31, 2026 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy Control Participants:

    1. 18yrs and older
    2. Left or Right hand dominance
    3. Age-matched to Focal Hand dystonia patients
    4. Must be able to sign informed consent
    5. Must be literate

  • Focal Hand dystonia Patients:

    1. 18yrs and older
    2. Left or Right hand dominance
    3. Diagnosed with Writer's Cramp dystonia in left or right hand
    4. Must be able to sign informed consent
    5. 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):

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10 Hz rTMS to premotor cortex
Device: Repetitive transcranial magnetic stimulation
10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session
Active Comparator: 10 Hz rTMS to primary somatosensory cortex
Device: Repetitive transcranial magnetic stimulation
10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session
Active Comparator: 0.7 Hz rTMS to premotor cortex
Device: Repetitive transcranial magnetic stimulation
10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Pre-TMS and post-TMS session (each session is approximately 45 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety, as Measured by TMS Acute Side Effects
Time Frame: During TMS session (each session is approximately 45 minutes)
During TMS session (each session is approximately 45 minutes)
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.
Pre-TMS and post-TMS session (each session is approximately 45 minutes)
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.
Post-TMS session (each session is approximately 45 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

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

Investigators

  • Principal Investigator: Noreen Bukhari-Parlakturk, MD PhD, Duke Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Actual)

January 13, 2023

Study Completion (Actual)

January 13, 2023

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00094131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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