Accelerated TMS for Focal Hand Dystonia

April 15, 2024 updated by: Duke University

Duke Accelerated Transcranial Magnetic Stimulation for Focal Hand Dystonia

This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal hand dystonia. Previous research demonstrated that individualized TMS improved dystonic behavior after one session. Building on this, the current study administers four TMS sessions in a day, with assessments conducted on the same day, two weeks, and twelve weeks after each session. The research involves 10 in-person visits and focuses on functional MRI brain scans and writing behavior analysis. 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 focal hand dystonia, paving the way for further advancements in clinical therapy for this condition.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this research is to investigate the impact of transcranial magnetic stimulation (TMS) on both brain function and behavioral outcomes among individuals suffering from focal hand dystonia. A preliminary examination of a previous TMS study carried out by our team revealed that the application of TMS, using personalized, fMRI-guided brain targeting and interleaved TMS delivery during motor tasks, has the potential to modify brain activity and ameliorate dystonic behavior after a single session of TMS in patients with focal hand dystonia. This present study seeks to build upon these promising findings by administering four TMS sessions in a single day, interspersed with four rest intervals, a protocol referred to as "accelerated TMS." The investigation will consist of a total of ten in-person appointments. Participants with focal hand dystonia will receive accelerated TMS during three in-person visits. Following each TMS session, participants will evaluate changes in brain function and behavior. During the assessment visits, individuals will undergo functional MRI brain scans and engage in writing tasks on an electronic tablet. The principal risk associated with TMS is the possibility of inducing a seizure. However, this study will strictly adhere to safety guidelines, utilizing TMS levels that have not previously been linked to seizures in properly screened individuals. Notably, the dosages of TMS proposed for use in this study have not caused seizures in healthy volunteers. To further mitigate the risk of seizures, potential subjects will undergo medical screening for any known factors that could predispose them to seizures. The primary advantage of this study lies in its potential to enhance dystonic behavior in patients with focal hand dystonia, while also deepening our comprehension of the foundational changes in brain function before and after TMS intervention for focal hand dystonia. The discoveries stemming from this investigation will pave the way for future research endeavors aimed at advancing brain stimulation as a viable clinical therapy for focal hand dystonia.

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Contact Backup

Study Locations

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

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

No

Description

Inclusion Criteria:

  • 18yrs and older
  • Diagnosed with isolated focal hand by Neurologist
  • Right-hand dominant
  • Must be able to sign an informed consent
  • Must be literate

Exclusion Criteria:

  • Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
  • History of seizure disorder
  • Concomitant medications are known to decrease seizure threshold
  • Illicit drug use
  • No TMS therapy for another indication within one month of this research study
  • Botulinum toxin injections within 3months of the 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 hand within one month of the study
  • Any contraindications to MRI or TMS

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TMS to premotor cortex
Participants receive TMS at premotor cortex
Device: Transcranial Magnetic Stimulation (TMS)
Participants will experience three accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.
Active Comparator: TMS to primary somatosensory cortex
Participants received TMS sessions at primary somatosensory cortex
Device: Transcranial Magnetic Stimulation (TMS)
Participants will experience three accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.
Sham Comparator: TMS at low amplitude to primary somatosensory cortex
Participants receive TMS at a cortical target at smaller amplitude
Device: Transcranial Magnetic Stimulation (TMS)
Participants will experience three accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in behavioral writing measure
Time Frame: 0 days, 2 weeks, and 12 weeks post-TMS
Using change in peak accelerations to assess writing behavior
0 days, 2 weeks, and 12 weeks post-TMS
Change in brain connectivity in the motor network
Time Frame: 0 days, 2 weeks and 12 weeks post-TMS
using functional magnetic resonance imaging of the brain
0 days, 2 weeks and 12 weeks post-TMS

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

American Academy of Neurology

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)

December 21, 2023

Primary Completion (Estimated)

March 9, 2025

Study Completion (Estimated)

March 9, 2025

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00112239

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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