Isolated Focal Hand DystoniaNCT06015672

Accelerated TMS for Focal Hand Dystonia

A study testing Transcranial Magnetic Stimulation (TMS) in people with Isolated Focal Hand Dystonia, run by Duke University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Isolated Focal Hand Dystonia
What is being tested?: Transcranial Magnetic Stimulation (TMS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 21 Dec 2023to 5 Feb 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18yrs and older
Diagnosed with isolated focal hand by Neurologist
Right-hand dominant
Must be able to sign an informed consent
Must be literate

Who cannot join

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

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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 locations and contacts

1 site in 1 country.

United States1 site

Duke University Health System
Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Duke Accelerated Transcranial Magnetic Stimulation for Focal Hand Dystonia

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.

Read the detailed 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.

Conditions: Isolated Focal Hand Dystonia
Being tested: Transcranial Magnetic Stimulation (TMS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Magnetic Stimulation (TMS)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.

Study groups in NCT06015672
Study group	Role	What they receive
TMS to primary somatosensory cortex	Active comparator	Participants received TMS sessions at primary somatosensory cortex Receives: Device: Transcranial Magnetic Stimulation (TMS)
TMS at low amplitude to primary somatosensory cortex	Sham comparator	Participants receive TMS at a cortical target at smaller amplitude Receives: Device: Transcranial Magnetic Stimulation (TMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in behavioral writing measure
Using change in peak accelerations to assess writing behavior
Measured: Baseline, 4 weeks, 12 weeks, 20 weeks, 24, weeks, 32 weeks and 40 weeks
Change in brain connectivity in the motor network
Using functional magnetic resonance imaging of the brain
Measured: Baseline, 12 weeks, 20 weeks and 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 20235 Feb 2027

First posted29 Aug 2023
Study start21 Dec 2023
Primary completion5 Feb 2027 (estimated)
Study completion5 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Isolated Focal Hand DystoniaStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Double-arm crossover study design with subjects receiving TMS at two different intensities
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06015672
Sponsor's protocol ID: Pro00112239
Status last verified: Feb 2026
First submitted: 23 Aug 2023
Last updated: 11 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Noreen Bukhari-Parlakturk, Patrick Mulcahey, Michael Lutz, Rabia Ghazi, Ziping Huang, Moritz Dannhauer, Zeynep Simsek, Skylar Groves, Mikaela Lipp, Michael Fei, Tiffany Tran, Eleanor Wood, Lysianne Beynel, Burton Scott, Pichet Termsarasab, Chris Petty, Hussein R Al-Khalidi, James Voyvodic, Lawrence G. Appelbaum, Simon Davis, Andrew Michael, Angel Peterchev, Nicole Calakos. "Functional MRI-guided individualized TMS modifies motor network and reduces writing dysfluency in Focal Hand Dystonia." Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation.
Noreen Bukhari-Parlakturk, Patrick Mulcahey, Michael Lutz, Rabia Ghazi, Ziping Huang, Moritz Dannhauer, Zeynep Simsek, Skylar Groves, Mikaela Lipp, Michael Fei, Tiffany Tran, Eleanor Wood, Lysianne Beynel, Burton Scott, Pichet Termsarasab, Chris Petty, Hussein R Al-Khalidi, James Voyvodic, Lawrence G. Appelbaum, Simon Davis, Andrew Michael, Angel Peterchev, Nicole Calakos. "Functional MRI-guided individualized TMS modifies motor network and reduces writing dysfluency in Focal Hand Dystonia." Samuel Belzberg 6th International Dystonia Symposium. Dublin, Ireland. June 1-3, 2023. poster presentation.
Bukhari-Parlakturk N, Lutz MW, Al-Khalidi HR, Unnithan S, Wang JE, Scott B, Termsarasab P, Appelbaum LG, Calakos N. Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp. Mov Disord. 2023 Jan;38(1):123-132. doi: 10.1002/mds.29237. Epub 2022 Oct 13.
PubMed 36226903
Dannhauer M, Huang Z, Beynel L, Wood E, Bukhari-Parlakturk N, Peterchev AV. TAP: targeting and analysis pipeline for optimization and verification of coil placement in transcranial magnetic stimulation. J Neural Eng. 2022 Apr 21;19(2):10.1088/1741-2552/ac63a4. doi: 10.1088/1741-2552/ac63a4.
PubMed 35377345