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Completed

NCT Number: NCT02370875

rTMS and Botulinum Toxin in Benign Essential Blepharospasm

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.

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Key information

Conditions

Benign Essential Blepharospasm

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magstim RapidStim2

Device

Application of repetitious transcranial magnetic stimulation (TMS) pulses using Magstim RapidStim2 to a specific brain target at predefined stimulation parameters.

Sham Magstim RapidStim2

Device

Same procedure as real rTMS without stimulating the cerebral cortex.

Primary outcomes

  1. Change in JRS Severity Score

    Time frame: 2 weeks after rTMS

    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.

  2. Change in JRS Frequency Score

    Time frame: 2 weeks after rTMS

    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.

  3. Change in Number of Sustained Forced Eye Blinks

    Time frame: 2 weeks after rTMS

    A video recording (5 minutes) was scored by two blinded neurologists to count the number of sustained forced eye-blinks.

  4. Change in Duration of Forced Blinks

    Time frame: 2 weeks after rTMS

    A video recording (5 minutes) was scored by two blinded neurologists to count the duration of sustained forced eye-blinks.

Secondary outcomes

  1. Change in CDQ-24 QOL Score

    Time frame: 2 weeks after rTMS

    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.

  2. Change in CDQ-24 ADL Subscore

    Time frame: 2 weeks after rTMS

    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.

  3. Change in Social Subscale of CDQ-24

    Time frame: 2 weeks after rTMS

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2015
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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