Accelerating TMS for Cervical Dystonia

Not Applicable

• Conditions: Isolated Cervical Dystonia
• Interventions: Device: Transcranial Magnetic Stimulation (TMS)

• Registration Number: NCT06328114
• Lead Sponsor: Duke University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-25
• Study Start: 2024-12-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2029-07-01
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sham TMS	Transcranial Magnetic Stimulation (TMS)	Participants receive sham TMS
TMS to primary somatosensory cortex	Transcranial Magnetic Stimulation (TMS)	Participants received TMS sessions at primary somatosensory cortex

Primary Outcome Measures

Name	Time	Method
Change in Neck Angles as Measured by Neck Sensor Device	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.

Secondary Outcome Measures

Name	Time	Method
Behavioral Response After Deep Brain Stimulation (DBS), as measured by Neck Angles	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.
Changes in Brain Activity (bold activity) on Functional Magnetic Resonance Imaging (fMRI)	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.
Changes in Brain Activity (functional connectivity) on Functional Magnetic Resonance Imaging (fMRI)	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.

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States