An interventional study of rTMS in Cervical Dystonia and Spasmodic Torticollis, sponsored by University of New Mexico. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-07-28.
Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment
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.
319 studies on the registry are indexed under Dystonia; 56 are open to participants now.
This study's enrollment of 8 is below the median of 32 across 181 interventional studies indexed under Dystonia.
Browse Dystonia studies →University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.2 Hz rTMS for 15 minutes
Device: rTMS
0.2 Hz rTMS for 15 minutes
Device: rTMS
0.2 Hz rTMS for 15 minutes
Device: rTMS
0.2 Hz rTMS for 15 minutes
Device: rTMS
0.2 Hz rTMS for 15 minutes
Device: rTMS
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).
Time frame: Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment
Dorsal Premotor-motor Inhibition (dPMI)
Time frame: 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."
Time frame: Assessment completed immediately after rTMS treatment session
| Milestone | Subject 1 | Subject 2 | Subject 3 | Subject 4 | Subject 5 | Subject 6 | Subject 7 | Subject 8 |
|---|---|---|---|---|---|---|---|---|
| Started | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Completed | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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).
| units on a scale | Primary Motor Cortex rTMS | Anterior Cingulate rTMS | Dorsal Premotor rTMS | Supplemental Motor Area rTMS | Sham rTMS |
|---|---|---|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) | -3.0 ± 4.8 | 0.25 ± 1.7 | -2.9 ± 3.4 | -1.5 ± 3.2 | -0.5 ± 1.1 |
| percentage | Primary Motor Cortex rTMS | Anterior Cingulate rTMS | Dorsal Premotor rTMS | Supplemental Motor Area rTMS | Sham rTMS |
|---|---|---|---|---|---|
| Dorsal Premotor-motor Inhibition (dPMI) | 57.50 ± 40.5 | 2.10 ± 24.5 | 21.08 ± 42.5 | 32.21 ± 53.5 | 19.71 ± 80 |
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."
| units on a scale | Primary Motor Cortex rTMS | Anterior Cingulate rTMS | Dorsal Premotor rTMS | Supplemental Motor Area rTMS | Sham rTMS |
|---|---|---|---|---|---|
| Composite Measure of Patient Rating of Symptoms and Tolerability | 1.6 ± 1.8 | 1.6 ± 2.8 | 1.5 ± 2.7 | 0.9 ± 1.1 | 0.8 ± 1.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subject 1 | — | 0/1 (0%) | 0/1 (0%) |
| Subject 2 | — | 0/1 (0%) | 0/1 (0%) |
| Subject 3 | — | 0/1 (0%) | 0/1 (0%) |
| Subject 4 | — | 0/1 (0%) | 0/1 (0%) |
| Subject 5 | — | 0/1 (0%) | 0/1 (0%) |
| Subject 6 | — | 0/1 (0%) | 0/1 (0%) |
| Subject 7 | — | 0/1 (0%) | 0/1 (0%) |
| Subject 8 | — | 0/1 (0%) | 0/1 (0%) |
| Age, Continuous(years) | Subject 1 | Subject 2 | Subject 3 | Subject 4 | Subject 5 | Subject 6 | Subject 7 | Subject 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 33 (33 to 33) | 60 (60 to 60) | 67 (67 to 67) | 31 (31 to 31) | 55 (55 to 55) | 41 (41 to 41) | 65 (65 to 65) | 72 (72 to 72) | 53 (31 to 72) |
| Sex: Female, Male(Participants) | Subject 1 | Subject 2 | Subject 3 | Subject 4 | Subject 5 | Subject 6 | Subject 7 | Subject 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 3 |
| Male | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 5 |
| Region of Enrollment(participants) | Subject 1 | Subject 2 | Subject 3 | Subject 4 | Subject 5 | Subject 6 | Subject 7 | Subject 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| United States | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 8 |
| TWSTRS Severity (Toronto Western Spasmodic Torticollis Rating Scale)(units on a scale) | Subject 1 | Subject 2 | Subject 3 | Subject 4 | Subject 5 | Subject 6 | Subject 7 | Subject 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 20 (20 to 20) | 9 (9 to 9) | 8 (8 to 8) | 14 (14 to 14) | 21 (21 to 21) | 20 (20 to 20) | 12 (12 to 12) | 16 (16 to 16) | 15 (8 to 20) |
| Dorsal Premotor-Motor Cortical Inhibition (DPMi)(Percentage) | Subject 1 | Subject 2 | Subject 3 | Subject 4 | Subject 5 | Subject 6 | Subject 7 | Subject 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 213 (213 to 213) | 127.50 (127.50 to 127.50) | 68.10 (68.10 to 68.10) | 71.60 (71.60 to 71.60) | NA (NA to NA) | NA (NA to NA) | 67.80 (67.80 to 67.80) | 72.30 (72.30 to 72.30) | NA (NA to NA) |
| Cortical Silent Period (CSP)(milliseconds) | Subject 1 | Subject 2 | Subject 3 | Subject 4 | Subject 5 | Subject 6 | Subject 7 | Subject 8 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 169.10 (169.10 to 169.10) | 153.70 (153.70 to 153.70) | 133.28 (133.28 to 133.28) | 78.10 (78.10 to 78.10) | 136.92 (136.92 to 136.92) | 76.24 (76.24 to 76.24) | 113.16 (113.16 to 113.16) | 99.76 (99.76 to 99.76) | 105.03 (76.24 to 169.10) |
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of New Mexico