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| ID | Type | Description | Link |
|---|---|---|---|
| U54NS065701 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Dystonia Coalition | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| University Health Network, Toronto |
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The overall objective of this application is to therapeutically target the dysfunctional premotor-motor interaction in dystonia-and to provide a focused treatment of specific anatomical networks in order to reduce side effects and to improve symptom control over conventional therapies.
We propose using repetitive transcranial magnetic stimulation (rTMS) over distinct premotor areas in patients with cervical dystonia (CD) with the goal of improving symptoms and reducing unwanted side effects. The knowledge gained in this proposed research will identify a specific premotor area to be targeted with rTMS that is expected to result in a novel intervention that could enhance or replace current treatments for CD. rTMS could be included as an adjunct treatment to botulinum toxin that could sustain treatment effect and decrease the frequency of re-injection, potentially resulting in cost savings without a decrease in symptom control. In addition to medical cost reduction, improved quality of life could be expected with the successful development of therapies that extend dystonia symptom control. rTMs has been FDA-approved for the treatment of depression and our proposal uses an even lower stimulation rate, suggesting continued use within clearly safe parameters. Successful completion of this research could lead to rapid adoption of this therapeutic modality.
We will test the hypothesis that rTMS of a distinct premotor site will provide more effective treatment of CD than non-specific activation of the entire premotor region. This will be done by performing a randomized, observer-blinded exploratory pilot study to determine the optimal site of rTMS over various sites of the premotor and motor cortex to improve the symptoms of cervical dystonia. Completion of this aim should lead to development of targeted TMS therapy for CD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dorsal Premotor rTMS | Active Comparator | 0.2 Hz rTMS for 15 minutes |
|
| Primary motor cortex rTMS | Active Comparator | 0.2 Hz rTMS for 15 minutes |
|
| Supplemental Motor Area rTMS | Active Comparator | 0.2 Hz rTMS for 15 minutes |
|
| Anterior Cingulate rTMS | Active Comparator | 0.2 Hz rTMS for 15 minutes |
|
| Sham rTMS | Sham Comparator | 0.2 Hz rTMS for 15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity). | Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Dorsal Premotor-motor Inhibition (dPMI) | Change from baseline dPMI to post-intervention within 1 hour of treatment | |
| Composite Measure of Patient Rating of Symptoms and Tolerability | This measure will confirm the intervention tolerability by the patient. He/she scored the tolerability from 0-10, 0 being "completely tolerable" and 10 "completely intolerable." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Pirio Richardson, MD | University of New Mexico | Principal Investigator |
| H.A. Jinnah, MD | Emory University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20633420 | Background | Beck S, Houdayer E, Richardson SP, Hallett M. The role of inhibition from the left dorsal premotor cortex in right-sided focal hand dystonia. Brain Stimul. 2009 Oct;2(4):208-14. doi: 10.1016/j.brs.2009.03.004. Epub 2009 May 3. | |
| 18285800 | Background | Breakefield XO, Blood AJ, Li Y, Hallett M, Hanson PI, Standaert DG. The pathophysiological basis of dystonias. Nat Rev Neurosci. 2008 Mar;9(3):222-34. doi: 10.1038/nrn2337. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subject 1 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex |
| FG001 | Subject 2 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area |
| FG002 | Subject 3 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex |
| FG003 | Subject 4 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex |
| FG004 | Subject 5 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex |
| FG005 | Subject 6 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex |
| FG006 | Subject 7 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area |
| FG007 | Subject 8 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subject 1 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex |
| BG001 | Subject 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity). | Posted | Mean | Standard Deviation | units on a scale | Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment |
|
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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 | Subject 1 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Pirio Richardson, MD | The University of New Mexico Health Sciences Center | 505-272-3342 | spiriorichardson@salud.unm.edu |
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| OTHER |
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| Assessment completed immediately after rTMS treatment session |
| 15501683 | Background | Lefaucheur JP, Fenelon G, Menard-Lefaucheur I, Wendling S, Nguyen JP. Low-frequency repetitive TMS of premotor cortex can reduce painful axial spasms in generalized secondary dystonia: a pilot study of three patients. Neurophysiol Clin. 2004 Oct;34(3-4):141-5. doi: 10.1016/j.neucli.2004.07.003. |
| 15483042 | Background | Murase N, Rothwell JC, Kaji R, Urushihara R, Nakamura K, Murayama N, Igasaki T, Sakata-Igasaki M, Mima T, Ikeda A, Shibasaki H. Subthreshold low-frequency repetitive transcranial magnetic stimulation over the premotor cortex modulates writer's cramp. Brain. 2005 Jan;128(Pt 1):104-15. doi: 10.1093/brain/awh315. Epub 2004 Oct 13. |
| 25923718 | Derived | Pirio Richardson S, Tinaz S, Chen R. Repetitive transcranial magnetic stimulation in cervical dystonia: effect of site and repetition in a randomized pilot trial. PLoS One. 2015 Apr 29;10(4):e0124937. doi: 10.1371/journal.pone.0124937. eCollection 2015. |
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area
| BG002 | Subject 3 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex |
| BG003 | Subject 4 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex |
| BG004 | Subject 5 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex |
| BG005 | Subject 6 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex |
| BG006 | Subject 7 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area |
| BG007 | Subject 8 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| TWSTRS Severity (Toronto Western Spasmodic Torticollis Rating Scale) | Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity). | Mean | Full Range | units on a scale |
|
| Dorsal Premotor-Motor Cortical Inhibition (DPMi) | Mean | Full Range | Percentage |
|
| Cortical Silent Period (CSP) | Mean | Full Range | milliseconds |
|
0.2Hz for 15 minutes: |
| OG003 | Supplemental Motor Area rTMS | 0.2Hz for 15 minutes: |
| OG004 | Sham rTMS | 0.2Hz for 15 minutes: |
|
|
| Secondary | Dorsal Premotor-motor Inhibition (dPMI) | two subjects did not have dPMI measured | Posted | Mean | Standard Deviation | percentage | Change from baseline dPMI to post-intervention within 1 hour of treatment |
|
|
|
| Secondary | Composite Measure of Patient Rating of Symptoms and Tolerability | This measure will confirm the intervention tolerability by the patient. He/she scored the tolerability from 0-10, 0 being "completely tolerable" and 10 "completely intolerable." | Posted | Mean | Standard Deviation | units on a scale | Assessment completed immediately after rTMS treatment session |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Subject 2 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area | 0 | 1 | 0 | 1 |
| EG002 | Subject 3 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex | 0 | 1 | 0 | 1 |
| EG003 | Subject 4 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex | 0 | 1 | 0 | 1 |
| EG004 | Subject 5 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex | 0 | 1 | 0 | 1 |
| EG005 | Subject 6 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex | 0 | 1 | 0 | 1 |
| EG006 | Subject 7 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area | 0 | 1 | 0 | 1 |
| EG007 | Subject 8 | Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes: Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex | 0 | 1 | 0 | 1 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |