N/A
N=12
rTMS and Botulinum Toxin in Benign Essential Blepharospasm
Benign Essential Blepharospasm
Bottom Line
View on ClinicalTrials.gov: NCT02370875 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Change in JRS Severity Score — -1.8; -0.1 Change in score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magstim RapidStim2 (Device); Sham Magstim RapidStim2 (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in JRS Severity Score |
-1.8; -0.1 | — |
| PRIMARY Change in JRS Frequency Score |
-1.4; -0.1 | — |
| PRIMARY Change in Number of Sustained Forced Eye Blinks |
-2.3; -0.5 | — |
| PRIMARY Change in Duration of Forced Blinks |
-2.6; -0.3 | — |
| SECONDARY Change in CDQ-24 QOL Score |
-10.6; -4.3 | — |
| SECONDARY Change in CDQ-24 ADL Subscore |
-30; -15 | — |
| SECONDARY Change in Social Subscale of CDQ-24 |
-15; -2.5 | — |
Summary
Benign essential blepharospasm (BEB) is a functionally disabling focal dystonia. Botulinum neurotoxin (BoNT) therapy is suboptimal in many BEB patients. Repetitious transcranial magnetic stimulation (rTMS) therapy is a promising noninvasive therapy and has shown positive benefits in BEB. rTMS therapy can be easily combined with BoNT injections to enhance the effects of BoNT in BEB.
Eligibility Criteria
Inclusion Criteria
- subjects diagnosed with blepharospasm or cranio-cervical dystonia who receive BoNT therapy at the Center for Movement Disorders will be approached. The investigators will enroll only those subjects who report experiencing positive benefits with BoNT but lasting about 10 weeks or less.
Exclusion Criteria
- pregnancy
- active seizure disorder
- significant cognitive impairment
- exposure to neuroleptics
- presence of a metallic body such as pacemaker, implants, prosthesis, artificial limb or joint, shunt, metal rods and hearing aid.
Data sourced from ClinicalTrials.gov (NCT02370875). 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.