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Trial record 1 of 51 for:    Benign Essential Blepharospasm
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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
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Benign Essential Blepharospasm Device: Magstim RapidStim2 Device: Sham Magstim RapidStim2 Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
United States, Florida
Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Aparna Wagle-Shukla, MD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02370875     History of Changes
Other Study ID Numbers: 201400993
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Blepharospasm
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs