rTMS and Botulinum Toxin in Benign Essential Blepharospasm
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|ClinicalTrials.gov Identifier: NCT02370875|
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : December 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Benign Essential Blepharospasm||Device: Magstim RapidStim2 Device: Sham Magstim RapidStim2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Combined Effects of rTMS and Botulinum Toxin in Benign Essential Blepharospasm: A Novel Approach|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Real rTMS stimulation
Repetitious transcranial magnetic stimulation (rTMS) will be delivered using the Magstim RapidStim2 over each anterior cingulate cortex, using a figure-of-eight coil. The investigators will apply rTMS with 0.2 Hz frequency to the ACC. 180 stimuli will be delivered with a stimulator output of 100% active motor threshold (AMT). AMT will be assessed at the tibialis anterior muscle with the coil. The AMT will be defined as the lowest stimulation intensity required to evoke a 150 μV potential in the target muscle. To determine the stimulation site for ACC, the coil will be placed over Fz and then moved over the midline of the brain in 0.5-cm steps anteriorly, until the point of maximum motor evoked potential in the orbicularis oculi (OO) muscle. The coil position will be marked on the skin. These rTMS sessions will be repeated daily for 10 days.
Device: Magstim RapidStim2
Application of repetitious transcranial magnetic stimulation (TMS) pulses using Magstim RapidStim2 to a specific brain target at predefined stimulation parameters.
Sham Comparator: Sham rTMS Stimulation
During sham repetitious transcranial magnetic stimulation (rTMS), subjects will undergo the same procedure for identifying stimulus location as used in patients receiving real rTMS using the sham Magstim RapidStim2 coil. This coil will be placed on the patient's head in an identical manner however will not be connected to the Magstim device. Instead another coil will be connected to provide stimulation sound. In each stimulation condition, the Magstim will be placed behind the patient and not visible to him or her. Placebo sham coil which produces discharge noise and vibration similar to a real coil without stimulating the cerebral cortex. During rTMS, all patients will continue to wear ear plugs as instructed during the real stimulation sessions.
Device: Sham Magstim RapidStim2
Same procedure as real rTMS without stimulating the cerebral cortex.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370875
|United States, Florida|
|Center for Movement Disorders and Neurorestoration|
|Gainesville, Florida, United States, 32607|
|Principal Investigator:||Aparna Wagle-Shukla, MD||University of Florida|