UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054562 |
|---|---|
| Receipt number | R000062217 |
| Scientific Title | Effects of combined neuromodulations on upper limb paralysis of stroke patients in acute phase |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/05/28 00:11:32 |
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Basic information
Public title
Do two differnt neuromodulators improve upper limb paralysis of stroke patients in acute phase?
Acronym
Verification of the effectiveness of neuromodulator for upper limb paralysis
Scientific Title
Effects of combined neuromodulations on upper limb paralysis of stroke patients in acute phase
Scientific Title:Acronym
Effects of combined neuromodulation on upper limb paralysis
Region
| Japan |
Condition
Condition
acute phase of stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifying the effect of neuromodulation on acute stroke upper limb paralysis.
Neuromodulation: transcranial direct current stimulation (tDCS) and repetitive peripheral magnetic stimulation(rPMS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer upper limb assessment
Key secondary outcomes
Wolf motor function test
Barthel index
Left and right grip strength/pinch strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention group receive occupational therapy using a combination of transcranial direct current stimulation and repetitive peripheral magnetic stimulation.
Occupational regular therapy is performed after completion of treatment.
Interventions/Control_2
Control group receive regular occupational therapy.
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
| 18 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, cerebrovascular malformation)
2) hospitalized adults within one weeks of stroke
3) first-ever, severe to moderate upper limb paralysis (Brunnstrom Stage: upper limb II-IV/fingers II-IV, Stroke impairment assessment set: knee-mouth test range 1-3 finger function test 1a-3)
4) level of consciousness is 1 digit on the Japan Coma Scale
5) adequate cognition to participate (target patients who can understand explanations)
6) medically stable
Key exclusion criteria
1) past history of convulsive seizures
2) past history of neuropsychiatric disorders
3) implanted stimulator (such as cardiac pacemaker)
4) past history of serious arrhythmia or heart failure
5) Patients with muscle disease
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | HIROYUKI |
| Middle name | |
| Last name | KURIHARA |
Organization
Saitama Medical University General Medical Center
Division name
Department of Rehabilitation medicine
Zip code
3508550
Address
1981 Kamota, Kawagoe City, Saitama Prefecture
TEL
049-228-3529
kuri610@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | HIROYUKI |
| Middle name | |
| Last name | KURIHARA |
Organization
Saitama Medical University General Medical Center
Division name
Department of Rehabilitation medicine
Zip code
3508850
Address
1981 Kamota, Kawagoe City, Saitama Prefecture
TEL
049-228-3529
Homepage URL
kuri610@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University General Medical Center
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
Saitama Medical University General Medical Center Clinical Research Support Center
Address
1981 Kamota, Kawagoe City, Saitama Prefecture
Tel
049-228-3902
smcrinri@saitama-med.ac.jp
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
埼玉医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | 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
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062217
