Accelerated TMS for Focal Hand Dystonia

Duke University

Status: Enrolling

Conditions: Isolated Focal Hand Dystonia

Treatments: Device: Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06015672

Pro00112239

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

TMS to primary somatosensory cortex

Active Comparator group

Description:

Participants received TMS sessions at primary somatosensory cortex

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

TMS at low amplitude to primary somatosensory cortex

Sham Comparator group

Description:

Participants receive TMS at a cortical target at smaller amplitude

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)