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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028802
Receipt No. R000032962
Scientific Title An open label single group study on the safety of integrated volitional control electrical stimulator (IVES) for amyotrophic lateral sclerosis
Date of disclosure of the study information 2017/08/24
Last modified on 2019/07/18

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Basic information
Public title An open label single group study on the safety of integrated volitional control electrical stimulator (IVES) for amyotrophic lateral sclerosis
Acronym A safety study on integrated volitional control electrical stimulator (IVES) for amyotrophic lateral sclerosis
Scientific Title An open label single group study on the safety of integrated volitional control electrical stimulator (IVES) for amyotrophic lateral sclerosis
Scientific Title:Acronym A safety study on integrated volitional control electrical stimulator (IVES) for amyotrophic lateral sclerosis
Region
Japan

Condition
Condition amyotrophic lateral sclerosis (ALS)
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validate whether integrated volitional control electrical stimulator (IVES) for amyotrophic lateral sclerosis can be performed safely without serious adverse events.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Primary outcome is the occurrence of serious adverse events.
Key secondary outcomes Secondary outcomes were manual muscle test, range of motion(ROM), grip strength, pinching strength, muscle strength with hand held dynamometer, Fugl-Meyer assessment, Wolf Motor Function Test, Motor Activity Log 14, Barthel index, Visual analogue scale, Borg scale.

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 IVES is attached to the patients, assisting the voluntary movement of the fingers. Under the supervision of occupational therapist, the patients undergo rehabilitation for 9 days with IVES for 30 minutes a day, 15 minutes for the flexors of the fingers and remaining 15 minutes for the extensors.
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. MMT of fingers flexion and fingers extension indicates 2-3.
2. The age at registration is from 20 years to 70 years.
3. Hospitalization or outpatient visit is possible during the intervention period
4. Written consent has been obtained
Key exclusion criteria 1. Decline in the cognitive function (MMSE 23 points or less)
2. Complication of frontal temporal lobular dementia
3. Muscle weakness due to neuromuscular disease other than ALS
4. Wearing a ventilator
5. Receiving non-invasive positive pressure ventilation therapy all day
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Yamaguchi
Organization Ichinomiya Nishi Hospital
Division name Neurology
Zip code
Address 1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, Japan
TEL 0586-48-0077
Email yamaguchikj@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Kanai
Organization Ichinomiya Nishi Hospital
Division name Neurology
Zip code
Address 1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, Japan
TEL 0586-48-0077
Homepage URL
Email masabilliard35@yahoo.co.jp

Sponsor
Institute Ichinomiya Nishi Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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
2017 Year 08 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
2017 Year 08 Month 18 Day
Anticipated trial start date
2017 Year 08 Month 24 Day
Last follow-up date
2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 23 Day
Last modified on
2019 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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