UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018761
Receipt number R000021704
Scientific Title Repetitive transcranial magnetic stimulation on dizziness after lateral medullary infarction
Date of disclosure of the study information 2015/09/01
Last modified on 2019/02/26 17:18:23

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Basic information

Public title

Repetitive transcranial magnetic stimulation on dizziness after lateral medullary infarction

Acronym

rTMS on lateral medullary infarction

Scientific Title

Repetitive transcranial magnetic stimulation on dizziness after lateral medullary infarction

Scientific Title:Acronym

rTMS on lateral medullary infarction

Region

Japan


Condition

Condition

Patients with dizziness after lateral medullary infarction

Classification by specialty

Neurology Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of rTMS on dizziness after lateral medullary infarction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

DHI and nystagmus (spontaneous, head-shaking, and positional) measured bebore, just after, and 1-, 2-, 3-, 6-month(s) after rTMS.

Key secondary outcomes

Vestibulo-ocular reflex (VOR)
VOR cancellation
SPECT


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Repetitive transcranial magnetic stimulation (600 pulses theta burst stimulation/day on cerebellum at 80% of motor threshold intensity using Magstim Rapid stimulator x 5 days)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with dizziness after lateral medullary infarction

Key exclusion criteria

Patients with contraindication of rTMS.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Johkura

Organization

Yokohama Brain and Spine Center

Division name

Department of Neurology

Zip code


Address

1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan

TEL

045-753-2500

Email

ke00-johkura@city.yokohama.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ken Johkura

Organization

Yokohama Brain and Spine Center

Division name

Department of Neurology

Zip code


Address

1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan

TEL

045-753-2500

Homepage URL


Email

ke00-johkura@city.yokohama.jp


Sponsor or person

Institute

Yokohama Brain and Spine Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

横浜市立脳卒中・神経脊椎センター  Yokohama Brain and Spine Center


Other administrative information

Date of disclosure of the study information

2015 Year 09 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


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

Completed

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 22 Day

Last modified on

2019 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021704


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name