Isolated Focal Hand DystoniaNCT06422104
Neuromodulation Therapy for Task-Specific Dystonia
A study testing Repetitive transcranial magnetic stimulation in people with Isolated Focal Hand Dystonia, run by Duke University at 1 site in United States.
Trial summary
This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Isolated Focal Hand Dystonia
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2018to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Control Participants:
- 18yrs and older
- Left or Right hand dominance
- Age-matched to Focal Hand dystonia patients
- Must be able to sign informed consent
- Must be literate
Show all 12Show fewer
- Focal Hand dystonia Patients:
- 18yrs and older
- Left or Right hand dominance
- Diagnosed with Writer's Cramp dystonia in left or right hand
- Must be able to sign informed consent
- Must be literate
Who cannot join
- Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5):
- Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
- Botulinum toxin injections within 3 months of research study
- Medications with effects on the central nervous system including anticholinergic, benzodiazepines, and muscle relaxants among others within 1 week of the study
- No physical or occupational therapy of the upper extremities
- Any contraindications to MRI (ie: metal in body or implanted medical devices, etc)
- Any contraindication on TMS adult safety screening (TASS form) including seizure history, pregnancy, brain injury, cranial metal implants, known structural brain lesion
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: Development of Mechanistically Informed Therapy for Task-Specific Dystonia Using Noninvasive Neuromodulation
This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after active rTMS compared to sham rTMS. A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS. The study will evaluate rTMS response using measures if writing on a sensor tablet, examiner and patient dystonia rating scales and brain imaging scan (functional MRI) to understand brain changes after rTMS. Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures.
Read the detailed description
The primary objective of this study is to develop rTMS for FHD. The focus is to assess whether stimulating the PMC or PSC will show greater improvement in writing behavior. This research builds upon prior studies that have demonstrated improvement in behavior after rTMS to PMC and PSC. The study includes five sequential visits:
- Visit 1 behavior writing measures and dystonia rating scales.
- Visit 2 includes task-based functional MRI brain scans to develop cortical target for rTMS sessions.
- Visits 3, 4, and 5: FHD participants receive 10 Hz rTMS to PMC, PSC and sham rTMS to PMC in a cross over design with at minimum one week of washout between sessions. Participants complete behavior writing measures and rating scales on same day before and after each TMS session and an fMRI after each TMS session. Up to 5 Healthy Volunteers were recruited to help develop the TMS visits.
The information in this record reflects Visits 3-5
- Conditions
- Isolated Focal Hand Dystonia
- Being tested
- Repetitive transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session
| Study group | Role | What they receive |
|---|---|---|
| 10 Hz rTMS to premotor cortex | Active comparator | 10 Hz rTMS to premotor cortex Receives: Device: Repetitive transcranial magnetic stimulation |
| 10 Hz rTMS to primary somatosensory cortex | Active comparator | 10 Hz rTMS to primary somatosensory cortex Receives: Device: Repetitive transcranial magnetic stimulation |
| 0.7 Hz rTMS to premotor cortex | Active comparator | 0.7 Hz rTMS to premotor cortex Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions
Measured: Pre-TMS and post-TMS session (each session is approximately 45 minutes)
Secondary outcomes (3)
Safety, as Measured by TMS Acute Side Effects
Measured: During TMS session (each session is approximately 45 minutes)
Change in Peak Accelerations Behavior (Calculated by Taking the Change in Peak Accelerations From Behavior Performed Before and After Each TMS Visit).
Change in peak accelerations behaviors pre- and post-TMS is calculated by taking the change in peak accelerations from behavior performed before and after each TMS visit. Higher measures of peak accelerations represent greater writing dysfluency and worsening dystonia.
Measured: Pre-TMS and post-TMS session (each session is approximately 45 minutes)
Brain Connectivity Between Superior Parietal Cortex to Right Cerebellum VIII
Brain connectivity was assessed using functional magnetic resonance imaging of the brain. The z-score is mathematical calculation of the synchronization between brain regions. Specifically, functional connectivity z-scores quantify the strength of synchronization between brain regions by transforming Pearson correlation coefficients (r-values) into normally distributed values (z-scores). This Fisher-z transformation stabilizes variance, enabling valid group-level statistical comparisons (e.g., t-tests) of functional connectivity. Positive Z-scores (Z scores> 0) represent stronger synchronization between brain regions and strengthening of connectivity between brain regions; negative Z-scores (Z-scores <0) indicate anti-synchronization between brain regions and weakening of connectivity between brain regions.
Measured: Post-TMS session (each session is approximately 45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start23 Aug 2018
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind cross-over design with participants receiving TMS at two cortical locations.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, Dystonia Coalition, Dystonia Study Group, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Noreen Bukhari-Parlakturk, MD PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422104
- Sponsor's protocol ID
- Pro00094131
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mulcahey PJ, Peterchev AV, Calakos N, Bukhari-Parlakturk N. Transcranial magnetic stimulation: the road to clinical therapy for dystonia. Dystonia. 2023 August; 2.
Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Organization of Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation.
Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. 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 35377345Bukhari-Parlakturk N, Mulcahey PJ, Lutz MW, Ghazi R, Huang Z, Dannhauer M, Termsarasab P, Scott B, Simsek ZB, Groves S, Lipp M, Fei M, Tran TK, Wood E, Beynel L, Petty C, Voyvodic JT, Appelbaum LG, Al-Khalidi HR, Davis SW, Michael AM, Peterchev AV, Calakos N. Motor network reorganization associated with rTMS-induced writing improvement in writer's cramp dystonia. Brain Stimul. 2025 Mar-Apr;18(2):198-210. doi: 10.1016/j.brs.2025.02.005. Epub 2025 Feb 7.
PubMed 39924101
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Mechanistically Informed Therapy for Task-Specific Dystonia Using Noninvasive Neuromodulation
- ClinicalTrials.gov ID
- NCT06422104
- Acronym / sponsor ID
- Pro00094131
- Conditions
- Isolated Focal Hand Dystonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, Dystonia Coalition, Dystonia Study Group, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Posted 13 Apr 2026
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 apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after active rTMS compared to sham rTMS. A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS. The study will evaluate rTMS response using measures if writing on a sensor tablet, examiner and patient dystonia rating scales and brain imaging scan (functional MRI) to understand brain changes after rTMS. Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures.
Detailed description
The primary objective of this study is to develop rTMS for FHD. The focus is to assess whether stimulating the PMC or PSC will show greater improvement in writing behavior. This research builds upon prior studies that have demonstrated improvement in behavior after rTMS to PMC and PSC. The study includes five sequential visits:
- Visit 1 behavior writing measures and dystonia rating scales.
- Visit 2 includes task-based functional MRI brain scans to develop cortical target for rTMS sessions.
- Visits 3, 4, and 5: FHD participants receive 10 Hz rTMS to PMC, PSC and sham rTMS to PMC in a cross over design with at minimum one week of washout between sessions. Participants complete behavior writing measures and rating scales on same day before and after each TMS session and an fMRI after each TMS session. Up to 5 Healthy Volunteers were recruited to help develop the TMS visits.
The information in this record reflects Visits 3-5
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind cross-over design with participants receiving TMS at two cortical locations.
| Arm | Type | Receives |
|---|---|---|
| 10 Hz rTMS to premotor cortex | Active comparator | Device: Repetitive transcranial magnetic stimulation10 Hz rTMS to premotor cortex |
| 10 Hz rTMS to primary somatosensory cortex | Active comparator | Device: Repetitive transcranial magnetic stimulation10 Hz rTMS to primary somatosensory cortex |
| 0.7 Hz rTMS to premotor cortex | Active comparator | Device: Repetitive transcranial magnetic stimulation0.7 Hz rTMS to premotor cortex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy Control Participants:
- Focal Hand dystonia Patients:
Key exclusion criteria (7 listed)
- Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5):
- Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
- Botulinum toxin injections within 3 months of research study
- Medications with effects on the central nervous system including anticholinergic, benzodiazepines, and muscle relaxants among others within 1 week of the study
- No physical or occupational therapy of the upper extremities
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulation10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session | Device | 0.7 Hz rTMS to premotor cortex, 10 Hz rTMS to premotor cortex, 10 Hz rTMS to primary somatosensory cortex |
Primary outcome
Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions
Time frame: Pre-TMS and post-TMS session (each session is approximately 45 minutes)
3 secondary outcomes
Safety, as Measured by TMS Acute Side Effects
Time frame: During TMS session (each session is approximately 45 minutes)
Change in Peak Accelerations Behavior (Calculated by Taking the Change in Peak Accelerations From Behavior Performed Before and After Each TMS Visit).
Time frame: Pre-TMS and post-TMS session (each session is approximately 45 minutes)
Brain Connectivity Between Superior Parietal Cortex to Right Cerebellum VIII
Time frame: Post-TMS session (each session is approximately 45 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundMulcahey PJ, Peterchev AV, Calakos N, Bukhari-Parlakturk N. Transcranial magnetic stimulation: the road to clinical therapy for dystonia. Dystonia. 2023 August; 2.
- BackgroundBukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Organization of Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation.
- BackgroundBukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. 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.
- Results publication: PubMed 39924101Bukhari-Parlakturk N, Mulcahey PJ, Lutz MW, Ghazi R, Huang Z, Dannhauer M, Termsarasab P, Scott B, Simsek ZB, Groves S, Lipp M, Fei M, Tran TK, Wood E, Beynel L, Petty C, Voyvodic JT, Appelbaum LG, Al-Khalidi HR, Davis SW, Michael AM, Peterchev AV, Calakos N. Motor network reorganization associated with rTMS-induced writing improvement in writer's cramp dystonia. Brain Stimul. 2025 Mar-Apr;18(2):198-210. doi: 10.1016/j.brs.2025.02.005. Epub 2025 Feb 7.
- Individual participant dataSharing planned: No
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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 Repetitive transcranial magnetic stimulation 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 12 inclusion and 7 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: finished, as of the sponsor's last update on 13 Apr 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. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions (time frame: Pre-TMS and post-TMS session (each session is approximately 45 minutes)). 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 NCT06422104, which also lists 6 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 13 Apr 2026.