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NCT02542839 · ClinicalTrials.gov registry record · NA
rTMS and Botulinum Toxin in Primary Cervical Dystonia
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT02542839: Completed NA study, sponsored by University of Florida.
NCT02542839 is a NA study that has completed, run by University of Florida. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02542839, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently reported as a source of disability, decreased quality of life, and social stigma. Botulinum toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure symptomatic benefits and does not seem to modify the disease pathophysiology. The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD. The primary goal of this study is to compare standard treatment with BoNT versus BoNT combined with a two week course of rTMS.
Primary Outcome
A clinical assessment of dystonia severity will be conducted at each study visit using the TWSTRS. The TWSTRS is a widely accepted composite rating scale for PCD with subscales for clinical severity, functional disability, and associated pain. The total score reported here can range 0-85, where a higher scores represent greater dystonia severity.
Interventions
- DEVICE NeuroStar TMS therapy
- DEVICE Sham NeuroStar TMS therapy
- OTHER Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
- OTHER Craniocervical Dystonia Questionnaire (CDQ-24)
- OTHER Cerebellar-brain Inhibition (CBI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2015-11 |
| Est. Completion | 2021-06-28 |
| Phase | NA |
What the finished NCT02542839 record still lists
NCT02542839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which NeuroStar TMS therapy is the first listed.
NCT02542839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02542839 about?
NCT02542839 is a clinical study titled "rTMS and Botulinum Toxin in Primary Cervical Dystonia". Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently reported as a source of disability, decreased quality of life, and social stigma. Botulinum toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from BoNT injections was abou...
What is the current status of trial NCT02542839?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2015-11. Estimated completion is 2021-06-28.
What interventions are being tested in trial NCT02542839?
The interventions under investigation include: NeuroStar TMS therapy (DEVICE), Sham NeuroStar TMS therapy (DEVICE), Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (OTHER), Craniocervical Dystonia Questionnaire (CDQ-24) (OTHER), Cerebellar-brain Inhibition (CBI) (OTHER).
Who is sponsoring clinical trial NCT02542839?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02542839's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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