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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
| Dystonia Coalition | OTHER |
| Dystonia Study Group | OTHER |
| National Center for Advancing Translational Sciences (NCATS) |
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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.
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:
The information in this record reflects Visits 3-5
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 Hz rTMS to premotor cortex | Active Comparator | 10 Hz rTMS to premotor cortex |
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| 10 Hz rTMS to primary somatosensory cortex | Active Comparator | 10 Hz rTMS to primary somatosensory cortex |
|
| 0.7 Hz rTMS to premotor cortex | Active Comparator | 0.7 Hz rTMS to premotor cortex |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation | Device | 10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions | Pre-TMS and post-TMS session (each session is approximately 45 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, as Measured by TMS Acute Side Effects | 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). |
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Inclusion Criteria:
Healthy Control Participants:
Focal Hand dystonia Patients:
Exclusion Criteria:
Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5):
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| Name | Affiliation | Role |
|---|---|---|
| Noreen Bukhari-Parlakturk, MD PhD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Mulcahey PJ, Peterchev AV, Calakos N, Bukhari-Parlakturk N. Transcranial magnetic stimulation: the road to clinical therapy for dystonia. Dystonia. 2023 August; 2. | ||
| Background | 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. | ||
| Background | 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. | ||
| 36226903 |
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The study was a cross-over design with multiple visits and measures to compare differences in data within participants across the three TMS conditions. Healthy volunteers were not enrolled in the trial represented in this results submission.
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| ID | Title | Description |
|---|---|---|
| FG000 | PMC, PSC, Sham | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Then, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Followed by Sham rTMS: Sham rTMS to PMC |
| FG001 | PMC, Sham, PSC | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Then, Sham rTMS: Sham rTMS to PMC Followed by rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex |
| FG002 | PSC, PMC, Sham | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Then, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Followed by Sham rTMS: Sham rTMS to PMC |
| FG003 | Sham, PMC, PSC | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, Sham rTMS: Sham rTMS to PMC Then, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Followed by rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex |
| FG004 | PSC, Sham, PMC | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Then, Sham rTMS: Sham rTMS to PMC Followed by rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex |
| FG005 | Sham, PSC, PMC | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, Sham rTMS: Sham rTMS to PMC Then, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Followed by rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First TMS Visit (1 Day) |
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| Washout (1 Week) |
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| Second TMS Visit (1 Day) |
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| Washout (1 Week) |
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| Third TMS Visit (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | PMC, PSC, Sham | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Then, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Followed by Sham rTMS: Sham rTMS to PMC |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions | Posted | Count of Participants | Participants | Pre-TMS and post-TMS session (each session is approximately 45 minutes) |
|
The standard TMS adverse events survey was collected before and after each TMS session. Each session lasted about 45 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rTMS to Premotor Cortex (PMC) | 10 Hz rTMS to premotor cortex | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noreen Bukhari-Parlakturk, MD PhD | Duke University Medical Center | (919) 684-8704 | noreen.bukhari@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2023 | Mar 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| NIH |
Double-blind cross-over design with participants receiving TMS at two cortical locations.
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The TMS intensity and cortical location delivered at each TMS visit will be masked
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.
| 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. | Post-TMS session (each session is approximately 45 minutes) |
| Background |
| 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. |
| 35377345 | Background | 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. |
| 39924101 | Result | Bukhari-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. |
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| PMC, Sham, PSC |
Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Then, Sham rTMS: Sham rTMS to PMC Followed by rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex |
| BG002 | PSC, PMC, Sham | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Then, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Followed by Sham rTMS: Sham rTMS to PMC |
| BG003 | Sham, PMC, PSC | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, Sham rTMS: Sham rTMS to PMC Then, rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex Followed by rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex |
| BG004 | PSC, Sham, PMC | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Then, Sham rTMS: Sham rTMS to PMC Followed by rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex |
| BG005 | Sham, PSC, PMC | Participants received rTMS in the order indicated with at least a 1 week wash-out period in between rTMS visits. First, Sham rTMS: Sham rTMS to PMC Then, rTMS to primary somatosensory cortex (PSC): 10 Hz rTMS to primary somatosensory cortex Followed by rTMS to premotor cortex (PMC): 10 Hz rTMS to premotor cortex |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Safety, as Measured by TMS Acute Side Effects | Due to technical issues during data collection, one participant's TMS visit (Sham) was not included in the data analysis. | Posted | Number | acute side affects | During TMS session (each session is approximately 45 minutes) |
|
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|
| Secondary | 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. | Due to technical issues during data collection, one participant's TMS visit (Sham) was not included in the data analysis. | Posted | Mean | Standard Error | percentage of pre-TMS session | Pre-TMS and post-TMS session (each session is approximately 45 minutes) |
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|
| Secondary | 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. | Due to technical issues during data collection, one participant's TMS visit (Sham) was not included in the data analysis. | Posted | Mean | Standard Error | z-score | Post-TMS session (each session is approximately 45 minutes) |
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| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | rTMS to Primary Somatosensory Cortex (PSC) | 10 Hz rTMS to primary somatosensory cortex | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Sham rTMS | Sham rTMS to premotor cortex | 0 | 12 | 0 | 12 | 0 | 12 |
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| Superiority |