N/A
N=5
Dystonia Treatment With Injections Supplemented By Transcranial Magnetic Stimulation
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT04916444 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) — 17; 16.6; 17; 15.8 score on a scale — p=0.691
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rTMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) |
17; 16.6; 17; 15.8; 15.8; 16.3 | 0.691 |
| SECONDARY Beck Depression Inventory (BDI) |
6.4; 8; 4.8; 7.4; 6.4; 7.6 | 0.816 |
| SECONDARY Trail-Making Test: Part A |
30.52; 28.92; 24.77; 28.66; 25.97; 22.26 | 0.167 |
| SECONDARY Trail-Making Test: Part B |
72.70; 72.77; 73.88; 66.44; 60.28; 68.48 | 0.507 |
| SECONDARY Wisconsin Card Sorting Task (WCST) - %Total Errors |
35.67; 25.25; 36.98; 28.11; 25.52; 36.89 | 0.056 |
| SECONDARY Wisconsin Card Sorting Task (WCST) - %Perseverative Errors |
16.57; 15.30; 15.76; 19.88; 16.39; 13.65 | 0.646 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- patients 18-85 years of age who receive regular botulinum toxin (BoNT) scheduled every 12 weeks, on stable optimized doses but with reported benefits lasting ≤ 9 weeks for 2 consecutive cycles. Patents followed at our center routinely fill out a self-reported form to document the duration of benefits perceived with BoNT therapy. Participants will be allowed to continue oral medications that they are taking for dystonia concurrently but will not be allowed to change their concurrent medication regimen throughout the duration of the study.
Exclusion Criteria
- Presence of metallic objects or neurostimulators in the brain
- Pregnancy
- History of active seizures or epilepsy
- Patients with severe scoliosis or other gait impairment that will preclude them from participating in gait evaluation.
Data sourced from ClinicalTrials.gov (NCT04916444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.