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Clinical Trial

Accelerating TMS for Cervical Dystonia

NCT: NCT06328114 · ENROLLING_BY_INVITATION

NCT IDNCT06328114
StatusENROLLING_BY_INVITATION
Start Date2024-12-17
Completion2029-07-01
SponsorDuke University (OTHER)
First posted
Last updated

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 six sessions of TMS separated by five rest blocks, all in a single day and combined with a medication called trihexyphenidyl given 30 minutes before the TMS session. This approach is called "anticholinergic enhanced accelerated TMS The research involves 8 in-person visits and 3 remote visits over 28 weeks. The effect of TMS will be assessed using functional MRI brain scans and behavioral measurements. Participants who are interested in enrolling in the TMS study to assess their potential presurgical response to DBS will only receive the active TMS session combined with trihexyphenidyl medication. After active TMS + trihexyphenidyl medication, participants will be followed for 3-5months to assess their brain and behavior response to TMS. Following clinical care DBS, participants will be followed for three additional research visits. The three visits will be performed at 1 month, 3 months and 6-9 months. During the post-DBS research visits, participants will complete behavioral assay and physiological assay to evaluate their neck movements and muscles. At 3 month or 6-9 month visit, the post-DBS participants will also undergo fMRI with the DBS device in off mode setting. 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.

Frequently Asked Questions

What is Accelerating TMS for Cervical Dystonia?

Accelerating TMS for Cervical Dystonia is a clinical trial registered under NCT06328114. Current status: ENROLLING_BY_INVITATION.

What is the status of NCT06328114?

The current status of NCT06328114 (Accelerating TMS for Cervical Dystonia) is: ENROLLING_BY_INVITATION.

When did Accelerating TMS for Cervical Dystonia start?

Accelerating TMS for Cervical Dystonia started on 2024-12-17.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.