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.
Trial summary
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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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
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 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.
Measurement of Hand Sensation using STDT
Surface skin electrodes will be placed on the index finger of the right hand of the participant. The anode will be located 0.5 cm distal to the cathode. The surface electrodes will be connected by a wire to a constant current stimulator. Participants will receive a stimulus consisting of a square-wave electrical pulse with a width of 0.2 milliseconds delivered with a constant current stimulator. A stimulation intensity will first be defined for each participant by delivering a series of stimuli at increasing intensity from 2 mA in steps of 1 mA; the intensity used for STDT will be the minimal intensity perceived by the participant in 10 of 10 consecutive stimuli. STDT will then be investigated using an ascending staircase method. Specifically, paired stimuli will be delivered to the anode and cathode skin electrodes attached to the participant's right-hand digit. The paired stimuli will be delivered starting with an interstimulus
Measured: Baseline, 4 weeks, 12 weeks, 20 weeks, 24, weeks, 32 weeks and 40 weeks
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- 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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Neurology
- Responsible party
- Sponsor
- Investigators
- Noreen Bukhari-Parlakturk, MD PhD, Principal investigator, Duke Health
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
- 26 Oct 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 36226903Dannhauer 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duke Accelerated Transcranial Magnetic Stimulation for Focal Hand Dystonia
- ClinicalTrials.gov ID
- NCT06015672
- Acronym / sponsor ID
- Pro00112239
- Conditions
- Isolated Focal Hand Dystonia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American Academy of Neurology
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-arm crossover study design with subjects receiving TMS at two different intensities
| Arm | Type | Receives |
|---|---|---|
| TMS to primary somatosensory cortex | Active comparator | Device: Transcranial Magnetic Stimulation (TMS)Participants received TMS sessions at primary somatosensory cortex |
| TMS at low amplitude to primary somatosensory cortex | Sham comparator | Device: Transcranial Magnetic Stimulation (TMS)Participants receive TMS at a cortical target at smaller amplitude |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18yrs and older
- Diagnosed with isolated focal hand by Neurologist
- Right-hand dominant
- Must be able to sign an informed consent
- Must be literate
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | TMS at low amplitude to primary somatosensory cortex, TMS to primary somatosensory cortex |
Primary outcome
Measurement of Hand Sensation using STDT
Time frame: Baseline, 4 weeks, 12 weeks, 20 weeks, 24, weeks, 32 weeks and 40 weeks
Surface skin electrodes will be placed on the index finger of the right hand of the participant. The anode will be located 0.5 cm distal to the cathode. The surface electrodes will be connected by a wire to a constant current stimulator. Participants will receive a stimulus consisting of a square-wave electrical pulse with a width of 0.2 milliseconds delivered with a constant current stimulator. A stimulation intensity will first be defined for each participant by delivering a series of stimuli at increasing intensity from 2 mA in steps of 1 mA; the intensity used for STDT will be the minimal intensity perceived by the participant in 10 of 10 consecutive stimuli. STDT will then be investigated using an ascending staircase method. Specifically, paired stimuli will be delivered to the anode and cathode skin electrodes attached to the participant's right-hand digit. The paired stimuli will be delivered starting with an interstimulus
1 secondary outcome
Change in behavioral writing measure
Time frame: Baseline, 4 weeks, 12 weeks, 20 weeks, 24, weeks, 32 weeks and 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- BackgroundNoreen 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.
- BackgroundNoreen 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.
- Background: PubMed 36226903Bukhari-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.
- Background: PubMed 35377345Dannhauer 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noreen Bukhari-Parlakturk, MD PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Isolated Focal Hand Dystonia, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Hand Sensation using STDT (time frame: Baseline, 4 weeks, 12 weeks, 20 weeks, 24, weeks, 32 weeks and 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06015672, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.