An interventional study of Magstim RapidStim2 and Sham Magstim RapidStim2 in Benign Essential Blepharospasm, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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.
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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
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
Application of repetitious transcranial magnetic stimulation (TMS) pulses using Magstim RapidStim2 to a specific brain target at predefined stimulation parameters.
Same procedure as real rTMS without stimulating the cerebral cortex.
Change in JRS Severity Score
The change in the score of the Jankovic Rating Scale subscore for severity. Rated on a 5-point scale (0-4), where a higher score indicates higher severity of blepharospasm.
Time frame: 2 weeks after rTMS
Change in JRS Frequency Score
The change in the score of the Jankovic Rating Scale subscore for frequency. Rated on a 5-point scale (0-4), where a higher score indicates higher frequency of forced blinks in blepharospasm.
Time frame: 2 weeks after rTMS
Change in Number of Sustained Forced Eye Blinks
A video recording (5 minutes) was scored by two blinded neurologists to count the number of sustained forced eye-blinks.
Time frame: 2 weeks after rTMS
Change in Duration of Forced Blinks
A video recording (5 minutes) was scored by two blinded neurologists to count the duration of sustained forced eye-blinks.
Time frame: 2 weeks after rTMS
Change in CDQ-24 QOL Score
Change in score of the Craniocervical dystonia questionnaire (CDQ-24), a self-reported questionnaire designed to evaluate the impact of dystonia on activities of daily living and quality of life. The total CDQ-24 score can therefore range from 0 to 96, with higher scores meaning greater impairment due to dystonia.
Time frame: 2 weeks after rTMS
Change in CDQ-24 ADL Subscore
Change in Actitivities of Daily Living (ADL) subscore of the Craniocervical dystonia questionnaire (CDQ-24), a questionnaire designed to evaluate quality of life outcomes for patients with dystonia. The ADL subscore is obtained from 6 of the 24 questions. Each question is rated on a 5-point scale (0-4), where a higher number indicates increasing severity of impairment for that daily activity due to dystonia. The total ADL subscore takes the sum of the number from five questions (a value from 0 to 24), then linearly transforms that sum to a 0-100 scale, where a higher score means greater impairment in daily life.
Time frame: 2 weeks after rTMS
Change in Social Subscale of CDQ-24
Change in the social subscore of the Craniocervical dystonia questionnaire (CDQ-24), a questionnaire designed to evaluate quality of life outcomes for patients with dystonia. The social subscore is obtained from 4 of the 24 questions. Each question is rated on a 5-point scale (0-4), where a higher number indicates increasing severity of social impairment due to dystonia. The total social subscore can therefore range from 0 to 16, with higher scores meaning greater impairment of social activities.
Time frame: 2 weeks after rTMS
| Milestone | Real rTMS Stimulation | Sham rTMS Stimulation |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
The change in the score of the Jankovic Rating Scale subscore for severity. Rated on a 5-point scale (0-4), where a higher score indicates higher severity of blepharospasm.
| Change in score | Real rTMS Stimulation | Sham rTMS Stimulation |
|---|---|---|
| Change in JRS Severity Score | -1.8 ± 0.8 | -0.1 ± 0.23 |
The change in the score of the Jankovic Rating Scale subscore for frequency. Rated on a 5-point scale (0-4), where a higher score indicates higher frequency of forced blinks in blepharospasm.
| Change in score | Real rTMS Stimulation | Sham rTMS Stimulation |
|---|---|---|
| Change in JRS Frequency Score | -1.4 ± 0.8 | -0.1 ± 0.2 |
A video recording (5 minutes) was scored by two blinded neurologists to count the number of sustained forced eye-blinks.
| blinks per 5 minutes | Real rTMS Stimulation | Sham rTMS Stimulation |
|---|---|---|
| Change in Number of Sustained Forced Eye Blinks | -2.3 ± 0.8 | -0.5 ± 0.1 |
A video recording (5 minutes) was scored by two blinded neurologists to count the duration of sustained forced eye-blinks.
| Change in seconds | Real rTMS Stimulation | Sham rTMS Stimulation |
|---|---|---|
| Change in Duration of Forced Blinks | -2.6 ± 1.1 | -0.3 ± 0.8 |
Change in score of the Craniocervical dystonia questionnaire (CDQ-24), a self-reported questionnaire designed to evaluate the impact of dystonia on activities of daily living and quality of life. The total CDQ-24 score can therefore range from 0 to 96, with higher scores meaning greater impairment due to dystonia.
| Change in score | Real rTMS Stimulation | Sham rTMS Stimulation |
|---|---|---|
| Change in CDQ-24 QOL Score | -10.6 ± 5.1 | -4.3 ± 2.1 |
Change in Actitivities of Daily Living (ADL) subscore of the Craniocervical dystonia questionnaire (CDQ-24), a questionnaire designed to evaluate quality of life outcomes for patients with dystonia. The ADL subscore is obtained from 6 of the 24 questions. Each question is rated on a 5-point scale (0-4), where a higher number indicates increasing severity of impairment for that daily activity due to dystonia. The total ADL subscore takes the sum of the number from five questions (a value from 0 to 24), then linearly transforms that sum to a 0-100 scale, where a higher score means greater impairment in daily life.
| Change in score | Real rTMS Stimulation | Sham rTMS Stimulation |
|---|---|---|
| Change in CDQ-24 ADL Subscore | -30 ± 12.1 | -15 ± 13.2 |
Change in the social subscore of the Craniocervical dystonia questionnaire (CDQ-24), a questionnaire designed to evaluate quality of life outcomes for patients with dystonia. The social subscore is obtained from 4 of the 24 questions. Each question is rated on a 5-point scale (0-4), where a higher number indicates increasing severity of social impairment due to dystonia. The total social subscore can therefore range from 0 to 16, with higher scores meaning greater impairment of social activities.
| Change in score | Real rTMS Stimulation | Sham rTMS Stimulation |
|---|---|---|
| Change in Social Subscale of CDQ-24 | -15 ± 11.2 | -2.5 ± 13.2 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Real rTMS Stimulation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Sham rTMS Stimulation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Real rTMS Stimulation | Sham rTMS Stimulation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 4 | 8 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(Years) | Real rTMS Stimulation | Sham rTMS Stimulation | Total |
|---|---|---|---|
| Mean | 68.8 ± 7.4 | 69.3 ± 7.2 | 69.1 ± 7.1 |
| Sex: Female, Male(Participants) | Real rTMS Stimulation | Sham rTMS Stimulation | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Real rTMS Stimulation | Sham rTMS Stimulation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 6 | 6 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Real rTMS Stimulation | Sham rTMS Stimulation | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
| BEB severity on Jankovic Rating Scale(Score on evaluation) | Real rTMS Stimulation | Sham rTMS Stimulation | Total |
|---|---|---|---|
| Mean | 3.1 ± 0.1 | 2.5 ± 1.1 | 2.8 ± 0.5 |
| BEB frequency on Jankovic Rating Scale(Score on evaluation) | Real rTMS Stimulation | Sham rTMS Stimulation | Total |
|---|---|---|---|
| Mean | 3.3 ± 0.7 | 2.6 ± 1.2 | 2.9 ± 0.8 |
| BEB blink frequency on video rating(Blinks per minute) | Real rTMS Stimulation | Sham rTMS Stimulation | Total |
|---|---|---|---|
| Mean | 38.7 ± 15.2 | 37 ± 16.7 | 37.9 ± 9.2 |
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Ran from Feb 2015 to primary completion in May 2017, 27 months.
Results were first posted in Sep 2023, 6 years 4 months after primary completion.
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Benign essential blepharospasm