rTMS and Botulinum Toxin in Benign Essential Blepharospasm

NCT02370875 | Completed Results DMC FDA Device

• 1 other identifier: 201400993
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Essential Blepharospasm

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Change in CDQ-24 QOL Score

  2 weeks after rTMS

• Change in CDQ-24 ADL Subscore

  2 weeks after rTMS

• Change in Social Subscale of CDQ-24

  2 weeks after rTMS

Study Arms (2)

Real rTMS stimulation

EXPERIMENTAL

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

Sham rTMS Stimulation

SHAM COMPARATOR

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

Interventions

Magstim RapidStim2 DEVICE

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

Real rTMS stimulation

Sham Magstim RapidStim2 DEVICE

Same procedure as real rTMS without stimulating the cerebral cortex.

Sham rTMS Stimulation

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Benign essential blepharospasm

Results Point of Contact

• Title: Aparna Wagle Shukla
• Organization: University of Florida

aparna.shukla@neurology.ufl.edu

3522945400

Study Officials

• Aparna Wagle-Shukla, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 25, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2017
• Last Updated: September 15, 2023
• Results First Posted: September 15, 2023

Record last verified: 2023-09

Locations

US (1)