Clinical Trial: rTMS and Botulinum Toxin in Benign Essential Blepharospasm

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Combined Effects of rTMS and Botulinum Toxin in Benign Essential Blepharospasm: A Novel Approach

Brief 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.

Detailed Summary: A two week course of rTMS therapy to achieve sustained benefits will be employed. With standard BoNT treatment, the peak-dose benefits are seen at about 4-6 weeks after the administration of injections. rTMS will be introduced during this peak-dose period (about 6 weeks after BoNT or T1).The effects of combined therapy at about 10 weeks after BoNT injections (T2) and at about 12 weeks after BoNT injections (T3) will be examined along with the physiological effects at these time points.
Sponsor: University of Florida

Current Primary Outcome:

  • Eye Blink Rate [ Time Frame: 0-12 weeks ]
    An eye blink will be defined as any visible, bilateral, and synchronous contraction of the orbicularis oculi (OO muscle), causing eyelid drop. Blink rate will be expressed as blinks per minute and will be determined from a 5 minute video.
  • Number of sustained blinks [ Time Frame: 0-12 weeks ]
    Sustained spasms of the OO muscle will counted as sustained blinks. separately and will be determined from a 5 minute video.
  • Time of eye closure [ Time Frame: 0-12 weeks ]
    The time (seconds) of eye closure whenever blinks cause prolonged eye closure (eyes shut > 2 seconds) will be recorded with a stopwatch and will be determined from a 5 minute video.
  • Jankovic rating scale (JRS) [ Time Frame: 0-12 weeks ]
    The JRS is made up of two subscales - severity and frequency - which are 5-point scales ranging from 0 to 4. Zero indicates no symptoms and 4 indicates the most severe or frequent symptoms.The higher the number the more severe the disease.
  • Blepharospasm disability index (BSDI) [ Time Frame: 0-12 weeks ]
    The BSDI consists of six daily activities each rated on a scale from 0 to 4. Zero indicates no impairment and 4 indicates not possible due to disease, and also includes a "not applicable" option. The higher the number the more severe the disease.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Craniocervical Dystonia Questionnaire (CDQ-24) [ Time Frame: 0-12 weeks ]
    CDQ-24 is a patient-rated health related quality of life (HR-QoL) measure for craniocervical dystonia. The CDQ-24 measures the impact of Craniocervical Dystonia on 5 HR-QoL domains. It is composed of 24 items, forming 5 subscales: stigma, emotional well-being, pain, activities of daily living, and social/ family life. Items are rated on a 5-point scale. Each item consists of five statements representing increasing severity of impairment, scored from 0 to 4. The higher the number the more severe the disease.
  • Clinical Global Impression- Subject (CGI-S) [ Time Frame: 0-12 weeks ]
    Subjects will also rate their symptoms before and after stimulation using a 7-point nominal scale: 1) excellent, 2) very good, 3) good, 4) average, 5) slightly worse than usual, 6) bad or 7) very bad.


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: February 10, 2015
Date Started: February 2015
Date Completion: November 2017
Last Updated: May 26, 2017
Last Verified: May 2017