UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031057
Receipt number R000035434
Scientific Title An exploratory clinical trial on the effectiveness and safety of skin electrical stimulation for Leber hereditary optic neuropathy
Date of disclosure of the study information 2018/04/01
Last modified on 2020/08/02 10:07:03

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Basic information

Public title

An exploratory clinical trial on the effectiveness and safety of skin electrical stimulation for Leber hereditary optic neuropathy

Acronym

A clinical trial of skin electrical stimulation for Leber hereditary optic neuropathy

Scientific Title

An exploratory clinical trial on the effectiveness and safety of skin electrical stimulation for Leber hereditary optic neuropathy

Scientific Title:Acronym

A clinical trial of skin electrical stimulation for Leber hereditary optic neuropathy

Region

Japan


Condition

Condition

Leber hereditary optic neuropathy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Leber hereditary optic neuropathy (LHON) is a disease, in which retinal ganglion cells falls into apoptotic cell death due to mainly one of three point mutations of mitochondrial DNA (mtDNA) at nucleotide positions 3460, 11778, 14484, characterized by acute or subacute vision loss of bilateral eyes with an inter-eye time lag in predominantly young males of second to fourth decade of life. Since LHON causes serious impairment of the central vision bilaterally and no effective treatment has been established, the development of a novel therapeutic approach is urgent. We will conduct an exploratory clinical trial to examine the effectiveness and safety of electric stimulation using skin electrical stimulation (SES) device for the improvement of the visual dysfunction in LHON patients. The clinical significance will be extremely high if the improvement of visual function is obtained by SES that can be easily and safely carried out.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

LogMAR visual acuity at 1 week after six consecutive skin electrical stimulation (once every two weeks for 10 weeks).

Key secondary outcomes

1. LogMAR visual acuity at 4 and 8 week after six consecutive skin electrical stimulation (once a week for 6 weeks).
2. Mean deviation and pattern standard deviation in Humphrey static visual field test (center 30-2, stimulus size 3 or 5), Foveal threshold value, total, the number of 1% and 5% of probability plot with pattern deviation
3. The value of critical fusion frequency
4. Color vision test (standard Pseudoisochromatic Plates Part 2 for Aquired Color Vision Defects (SPP-2))
5. Thickness of peripapillary retinal nerve fiber and macular retinal ganglion cell complex detected by optical coherence tomography
6. The sensitivity of central visual field detected by Micrometry (MP-3)
7. The amplitude of visual evoked potential (Multifocal VEP)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Skin electrical stimulation (SES), The number of intervention is six times (single SES every two weeks for 10 weeks)

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



Eligibility

Age-lower limit

16 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Inclusion criteria
Subjects should fulfill all conditions as follows:
1. Patients with ages ranging from 16 and 80 years of age.
2. Patients who provide written informed consent. In cases under 20 years, informed consent must be obtained from both patients themselves and guardians.
3. Patients with the disease more than 8 months since onset without visual improvement.
4. Patients with a missense mutation of mtDNA at the positon 11778.
5. Patients who show best corrected decimal visual acuity less than 0.1.

Key exclusion criteria

Exclusion criteria
Patients who have at least one condition as below will be excluded.
1. Patients who had smoked until the last half of year
2. Patients with implantable electronic devices such as cardiac pacemakers etc.
3. Patients with a history of intraocular surgery within the past a year
4. Patients with other eye diseases except for the eyes with incipient cataract or intraocular lens
5. Patients who use idebenone and have past history of administration of idebenone within 1 year
6. Patients who use either ethambutol, chloramphenicol, linezolid, erythromycin, streptomycin, antiretroviral drugs, amiodarone, infliximab, clioquinol, dapsone, quinine, pheniprazine, suramin sodium, or isoniazid.
7. Patients with a history of epilepsy
8. Pregnant individuals
9. Patients with severe allergic diseases including atopic dermatitis
10. Patients participating in other clinical studies
11. Patients judged inappropriate for other research responsible doctors

Target sample size

11


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuji Kurimoto

Organization

Kobe University Graduate School of Medicine

Division name

Ophthalmology

Zip code


Address

7-5-2 Kusunoki-cho Chuo-ku Kobe

TEL

078-382-5111

Email

kuri1201@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuji Kurimoto

Organization

Kobe University Graduate School of Medicine

Division name

Ophthalmology

Zip code


Address

7-5-2 Kusunoki-cho Chuo-ku Kobe

TEL

078-382-5111

Homepage URL


Email

kuri1201@med.kobe-u.ac.jp


Sponsor or person

Institute

Department of Surgery, Devision of Ophthalmology, Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Surgery, Devision of Ophthalmology, Kobe University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

11

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


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 03 Month 20 Day

Date of IRB

2018 Year 03 Month 20 Day

Anticipated trial start date

2018 Year 03 Month 28 Day

Last follow-up date

2019 Year 09 Month 01 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 30 Day

Last modified on

2020 Year 08 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035434


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name