Accelerated TMS for Focal Hand 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

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-21

Study Completion Date

2025-12-31

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 hand dystonia. Previous research demonstrated that individualized TMS improved dystonic behavior after one session. Building on this, the current study administers four TMS sessions in a day, with assessments conducted in four weeks, twelve weeks, and 20 weeks after each session. The research involves 8 in-person and 6 virtual visits focused on functional MRI brain scans and writing behavior analysis. 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 focal hand 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 suffering from focal hand dystonia. A preliminary examination of a previous TMS study carried out by our team revealed that the application of TMS, using personalized, fMRI-guided brain targeting and interleaved TMS delivery during motor tasks, has the potential to modify brain activity and ameliorate dystonic behavior after a single session of TMS in patients with focal hand dystonia. This present study seeks to build upon these promising findings by administering four TMS sessions in a single day, interspersed with four rest intervals, a protocol referred to as "accelerated TMS." The investigation will consist of a total of eight in-person appointments. Participants with focal hand dystonia will receive accelerated TMS during two in-person visits. Following each TMS session, participants will evaluate changes in brain function and behavior. During the assessment visits, individuals will undergo functional MRI brain scans and engage in writing tasks on an electronic tablet. 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. Notably, 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 lies in its potential to enhance dystonic behavior in patients with focal hand dystonia, while also deepening our comprehension of the foundational changes in brain function before and after TMS intervention for focal hand dystonia. 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 focal hand dystonia.

Conditions

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Isolated Focal Hand Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The TMS intensity delivered at each TMS visit will be masked

Study Groups

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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 have two accelerated transcranial magnetic stimulation (TMS) visits. Each TMS visit will be separated by 5 months. During each TMS visit, they will receive four TMS sessions, each separated by 60 minutes of rest.

TMS at low amplitude to primary somatosensory cortex

Participants receive TMS at a cortical target at smaller amplitude

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type DEVICE

Participants will have two accelerated transcranial magnetic stimulation (TMS) visits. Each TMS visit will be separated by 5 months. During each TMS visit, they will receive four TMS sessions, each separated by 60 minutes of rest.

Interventions

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Transcranial Magnetic Stimulation (TMS)

Participants will have two accelerated transcranial magnetic stimulation (TMS) visits. Each TMS visit will be separated by 5 months. During each TMS visit, they will receive four TMS sessions, each separated by 60 minutes of rest.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18yrs and older
* Diagnosed with isolated focal hand by Neurologist
* Right-hand dominant
* 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 are 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 3months 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 hand within one month of the study
* Any contraindications to MRI or TMS

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No