UMIN-ICDS Clinical Trial

Public title

A study of how eyelid symptoms and eyelid muscle activity change when patients with blepharospasm wear a headband-type temple-pressing device

Acronym

Blepharospasm Temple Compression Study

Scientific Title

A multimodal exploratory prospective study to elucidate the pathophysiological mechanism of the sensory trick phenomenon in blepharospasm: an investigation using temple compression stimulation

Scientific Title:Acronym

Blepharospasm Sensory Trick Multimodal Study (BSTM Study)

Region

Japan

Condition

Blepharospasm (idiopathic)

Classification by specialty

Ophthalmology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate, using multiple modalities, how subjective symptoms, clinical findings, physiological indices (orbicularis oculi muscle activity and blink dynamics), visual function, and quality of life change before and after wearing a headband-type temple compression device (a non-medical device) in patients with blepharospasm, and thereby to exploratively elucidate the pathophysiological mechanism of the sensory trick phenomenon (symptom relief by temple compression) frequently observed in blepharospasm.

Basic objectives2

Others

Basic objectives -Others

Exploration of the pathophysiological mechanism of the sensory trick phenomenon

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Change in the Blepharospasm Disability Index (BSDI; subjective symptom score) from the first visit (before at-home device use) to the second visit (after approximately 3-4 months of at-home device use)

Key secondary outcomes

(1) Changes before and while wearing the device at the first visit in: Jankovic rating scale, functional visual acuity, surface electromyography / electrooculography indices (mean amplitude, muscle activity duration, etc.), and blink dynamics (blink rate, etc.); and the participant's report of whether symptoms were relieved while wearing the device
(2) Changes from the first visit to the second visit (approximately 3-4 months later) in: Craniocervical Dystonia Questionnaire (CDQ-24), Dry Eye-related Quality of life Score (DEQS), and Jankovic rating scale
(3) Association between at-home stimulation exposure (days and hours of device use, based on participants' self-records) and the change in each index

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Wearing of a headband-type temple compression device (non-medical device). At the first visit (day of botulinum toxin injection), the device is fitted (participants choose from four sizes the one that gives a comfortable pressure when the protrusions are placed on the temples), and assessments (clinical rating, functional visual acuity, blink video, surface EMG / EOG) are performed before and while wearing the device, together with a question on whether symptoms are relieved while wearing it. Questionnaires (BSDI, CDQ-24, DEQS) are administered once at each visit. The device is then lent to the participant until the next scheduled botulinum toxin injection (approximately 3-4 months later) with instructions to wear it at home as far as possible during daily activities (e.g., reading, watching TV), and participants keep a self-record of use (days worn, approximate hours per day, situations, comfort, and skin condition). The same assessments are repeated at the second visit, and device use is reviewed based on the self-record. Botulinum toxin injection therapy is given as routine care; its protocol and interval are not altered for this study.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients with idiopathic blepharospasm treated at a participating institution during the study period who meet all of the following:
(1) Judged to be indicated for botulinum toxin injection for blepharospasm (including both patients already receiving and patients who have never received botulinum toxin injection)
(2) Written informed consent obtained

Key exclusion criteria

(1) Patients with hemifacial spasm
(2) Patients with cerebral or neurological disease
(3) Patients unable to participate because they cannot describe their symptoms or history due to dementia or similar conditions

Target sample size

60

Name of lead principal investigator

1st name	Yoshiyuki
Middle name
Last name	Kitaguchi

Organization

Graduate School of Medicine, The University of Osaka

Division name

Department of Ophthalmology

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3456

Email

kitaguchi@ophthal.med.osaka-u.ac.jp

Name of contact person

1st name	Yoshiyuki
Middle name
Last name	Kitaguchi

Organization

Graduate School of Medicine, The University of Osaka

Division name

Department of Ophthalmology

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3456

Homepage URL

Email

kitaguchi@ophthal.med.osaka-u.ac.jp

Institute

Department of Ophthalmology, Graduate School of Medicine, The University of Osaka

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Department of Ophthalmology, Hyogo Medical University

Name of secondary funder(s)

Ministry of Education, Culture, Sports, Science and Technology / Japan Society for the Promotion of Science (Grants-in-Aid for Scientific Research); The University of Osaka (operating grant)

Organization

Institutional Review Board, Osaka University Hospital

Address

2-15 Yamadaoka, Suita, Osaka 565-0871, Japan

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院（大阪府）、兵庫医科大学病院（兵庫県）

Date of disclosure of the study information

2026

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

No

IPD sharing Plan description

There is no plan to share anonymized individual participant data with third parties.

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

15

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter, single-arm, prospective interventional study (minimally invasive) conducted at Osaka University Hospital and Hyogo Medical University. Clinical indices (BSDI, CDQ-24, DEQS, Jankovic rating scale, functional visual acuity, blink video) are assessed in all participants at both sites (n = 60). Because the physiological measurement devices differ between sites, orbicularis oculi activity by surface electromyography is assessed in 30 participants at Osaka University Hospital, and electrooculography / blink dynamics by a smart eyeglass device (JINS MEME) in 30 participants at Hyogo Medical University. Exploratory analyses are stratified by the presence or absence of a sensory trick response to temple compression (determined at enrollment). The study is not designed to test a specific hypothesis, and the sample size was not based on statistical power.

Registered date

2026

Year

09

Month

20

Day

Last modified on

2026

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072122