rTMS and Botulinum Toxin in Benign Essential Blepharospasm

Benign Essential Blepharospasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370875
• Other study ID #: 201400993
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: November 2017

Study information

• Verified date: September 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Essential Blepharospasm
• Blepharospasm

Intervention

Device:
• Magstim RapidStim2
Application of repetitious transcranial magnetic stimulation (TMS) pulses using Magstim RapidStim2 to a specific brain target at predefined stimulation parameters.
• Sham Magstim RapidStim2
Same procedure as real rTMS without stimulating the cerebral cortex.

Locations

Country	Name	City	State
United States	Center for Movement Disorders and Neurorestoration	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks after rTMS
Primary	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.	2 weeks after rTMS
Primary	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.	2 weeks after rTMS
Primary	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.	2 weeks after rTMS
Secondary	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.	2 weeks after rTMS
Secondary	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.	2 weeks after rTMS
Secondary	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.	2 weeks after rTMS