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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Participants will experience two accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.
Duke University Health System
Durham, North Carolina, United States
Change in Neck Angles as Measured by Neck Sensor Device
Mixed modeling will be used to compare the degree of neck angle movements between active TMS, sham TMS, and baseline visits.
Time frame: Baseline, approximately 7 months (visit 9)
Changes in Brain Activity (bold activity) on Functional Magnetic Resonance Imaging (fMRI)
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.
Time frame: Baseline (visit 1) to approximately 4 weeks (visit 7)
Changes in Brain Activity (functional connectivity) on Functional Magnetic Resonance Imaging (fMRI)
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.
Time frame: Baseline (visit 1) to approximately 4 weeks (visit 7)
Behavioral Response After Deep Brain Stimulation (DBS), as measured by Neck Angles
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.
Time frame: Approximately 6 weeks post-DBS (visit 8), approximately 7 months (visit 9)
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