Accelerating TMS for Cervical Dystonia

April 24, 2024 updated by: Duke University

Functional Magnetic Resonance Imaging (fMRI)-Guided Individualized Transcranial Magnetic Stimulation (TMS) for Cervical Dystonia

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 four TMS sessions in a day. The research involves 9 in-person visits. The effect of TMS will be assessed using functional MRI brain scans and behavioral measurements. 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.

Study Overview

Status

Not yet 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 with cervical dystonia. A previous TMS study carried out by our team revealed that the application of TMS using a personalized brain targeting approach in focal hand dystonia resulted in improved measures of writing disfluency and changes in the motor network. This study seeks to expand these promising findings to individuals with cervical dystonia. Subjects in the study will receive four TMS sessions in a single day with a protocol referred to as "accelerated TMS." The investigation will consist of a total of 9 in-person appointments. Participants with cervical dystonia will receive accelerated TMS during two in-person visits. Following each TMS session, participants will evaluate changes in brain function using function MRI and behavior using a behavior assay. 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. 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 is that it may improve neck movement behavior in patients with cervical dystonia, while also advancing our understanding in brain function before and after TMS intervention. 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 cervical dystonia.

Study Type

Interventional

Enrollment (Estimated)

50

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

  • Name: Noreen Bukhari-Parlakturk, MD PhD
  • Phone Number: (919) 668-8248
  • Email: movdisres@duke.edu

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • 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 cervical dystonia by Neurologist
  • 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 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 3 months 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 neck 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TMS to primary somatosensory cortex
Participants received TMS sessions at primary somatosensory cortex
Device: Transcranial Magnetic Stimulation (TMS)
Participants will experience two accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.
Sham Comparator: sham TMS
Participants receive sham TMS
Device: Transcranial Magnetic Stimulation (TMS)
Participants will experience two 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 Neck Angles as Measured by Neck Sensor Device
Time Frame: Baseline, approximately 7 months (visit 9)
Mixed modeling will be used to compare the degree of neck angle movements between active TMS, sham TMS, and baseline visits.
Baseline, approximately 7 months (visit 9)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Brain Activity (bold activity) on Functional Magnetic Resonance Imaging (fMRI)
Time Frame: Baseline (visit 1) to approximately 4 weeks (visit 7)
The investigators will conduct a region of interest analysis in the motor network of the brain to calculate changes of fMRI bold activity after each TMS session.
Baseline (visit 1) to approximately 4 weeks (visit 7)
Changes in Brain Activity (functional connectivity) on Functional Magnetic Resonance Imaging (fMRI)
Time Frame: Baseline (visit 1) to approximately 4 weeks (visit 7)
The investigators will conduct a region of interest analysis in the motor network of the brain to calculate changes of fMRI functional connectivity after each TMS session.
Baseline (visit 1) to approximately 4 weeks (visit 7)
Behavioral Response After Deep Brain Stimulation (DBS), as measured by Neck Angles
Time Frame: Approximately 6 weeks post-DBS (visit 8), approximately 7 months (visit 9)
If participants undergo DBS, the investigators will collect neck angles over time post-DBS and correlate with the subject's neck angles over time post-TMS.
Approximately 6 weeks post-DBS (visit 8), approximately 7 months (visit 9)

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00114549

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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