Accelerating TMS for Cervical Dystonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-17

Study Completion Date

2029-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Isolated Cervical Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single-arm crossover study design with subjects receiving TMS at two different intensities

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

The TMS intensity delivered at each TMS visit will be masked

Study Groups

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sham TMS

Participants receive sham TMS

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type DEVICE

Participants will experience two accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.

TMS to primary somatosensory cortex

Participants received TMS sessions at primary somatosensory cortex

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type DEVICE

Participants will experience two accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.

Interventions

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Transcranial Magnetic Stimulation (TMS)

Participants will experience two accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No