N/A
N=9
rTMS and Botulinum Toxin in Primary Cervical Dystonia
Primary Cervical Dystonia · Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT02542839 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Dystonia Severity as Assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) — 13; 17 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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); Botulinum toxin injections (Procedure)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dystonia Severity as Assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) |
13; 17 | — |
| SECONDARY TMS Measure Referred to as Cerebellar Inhibition (CBI) |
0.7; 0.9 | — |
| SECONDARY Craniocervical Dystonia Questionnaire |
16; 18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of PCD in accordance with the Consensus Statement of the Movement Disorder Society
- Subjects who report Botulinum Toxin benefits lasting 10 weeks or less only (suboptimal benefits with standard care)
Exclusion Criteria
- Pregnancy
- Active seizure disorder
- Presence of a metallic body such as pacemaker, implants, metal rods and hearing aid.
Data sourced from ClinicalTrials.gov (NCT02542839). 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.