Adults 18 to 85, any sex, with Cervical Dystonia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)Primary· Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)
This is an objective scale evaluating patients on a variety of features including maximal excursion, duration, effects of sensory trick, shoulder elevation, range of motion, and time. Scores range from 0 to 85 where a higher score indicates more severity.
This is a 21-question survey evaluating depression in patients on a 0 to 3 scale, with a minimum score of 0 and maximum score 63, and higher score indicating a higher level of depression.
Before rTMS
Group
Value
95% CI
Active rTMS
6.4
± 6.39
Sham rTMS
8
± 7
Immediately after rTMS
Group
Value
95% CI
Active rTMS
4.8
± 4.44
Sham rTMS
7.4
± 4.83
2 weeks after rTMS
Group
Value
95% CI
Active rTMS
6.4
± 5.68
Sham rTMS
7.6
± 6.02
Trail-Making Test: Part ASecondary· Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)
Patients are instructed to connect circles in ascending numerical order and are scored on how quickly they are able to complete the task. A longer amount of time indicates more severe cognitive impairment (in general, more than 78 seconds to complete Part A is considered impaired).
Before rTMS
Group
Value
95% CI
Active rTMS
30.52
± 9.78
Sham rTMS
28.92
± 12.19
Immediately after rTMS
Group
Value
95% CI
Active rTMS
24.77
± 9.07
Sham rTMS
28.66
± 12.27
2 weeks after rTMS
Group
Value
95% CI
Active rTMS
25.97
± 7.90
Sham rTMS
22.26
± 5.69
Trail-Making Test: Part BSecondary· Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)
Patients are instructed to connect circles in ascending numerical order and are scored on how quickly they are able to complete the task. A longer amount of time indicates more severe cognitive impairment (in general, more than 273 seconds to complete Part B is considered impaired).
The Wisconsin Card Sorting Test is a test of rule-learning and conceptual flexibility. The participant is required to learn to sort a series of cards according to one of three principles (color, form or number) based on response feedback. This measure is computed by calculating the ration of total errors to trials administered and multiplied by 100.
The Wisconsin Card Sorting Test is a test of rule-learning and conceptual flexibility. The participant is required to learn to sort a series of cards according to one of three principles (color, form or number) based on response feedback. This measure reflects the "density" of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of total errors to trials administered and multiplied by 100.
Before rTMS
Group
Value
95% CI
Active rTMS
16.57
± 11.92
Sham rTMS
15.30
± 5.19
Immediately after rTMS
Group
Value
95% CI
Active rTMS
15.76
± 20.43
Sham rTMS
19.88
± 15.44
2 weeks after rTMS
Group
Value
95% CI
Active rTMS
16.39
± 9.95
Sham rTMS
13.65
± 13.72
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
We applied 16 sessions of rTMS over 4 consecutive days for adult patients suffering from cervical dystonia who received botulinum toxin (BoNT) injections on a regular basis. The TMS protocol took place 9 weeks following their last BoNT injection. The primary outcome measure was improvement in cervical dystonia as measured by the TWSTRS scale. The secondary outcome measures included mood, cognition, and gait measures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Florida
Last refreshed: 8 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04916444.