UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056301 |
|---|---|
| Receipt number | R000064330 |
| Scientific Title | Effects of repetitive somatosensory stimulation on somatosensory deficits in patients with acute stroke |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/11/28 20:08:15 |
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Basic information
Public title
Effects of repetitive somatosensory stimulation on somatosensory deficits in patients with acute stroke
Acronym
Effects of repetitive somatosensory stimulation on somatosensory deficits in patients with acute stroke
Scientific Title
Effects of repetitive somatosensory stimulation on somatosensory deficits in patients with acute stroke
Scientific Title:Acronym
Effects of repetitive somatosensory stimulation on somatosensory deficits in patients with acute stroke
Region
| Japan |
Condition
Condition
Patients with acute stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether peripheral nerve somatosensory stimulation is effective in the rehabilitation of somatosensory deficits in patients with acute stroke. We will clarify the effects of peripheral nerve somatosensory stimulation on somatosensory and motor functions and the neurophysiological mechanisms underlying the intervention effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Somatosensory evoked potentials
Key secondary outcomes
Tactile threshold
Vibration threshold
Two-point discrimination threshold
Fugl-meyer assessment
Action research arm test
Box and Block test
9-hole peg test
Grip strength
Functional independence measure (FIM)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Peripheral nerve somatosensory stimulation group
3 cm2 (1.5 x 2.0 cm) surface electrode is used as the stimulating electrode, and the peripheral nerves in the carpal region (median nerve and ulnar nerve) are stimulated. Electrical stimulation of both peripheral nerves is synchronized for simultaneous stimulation. Pulsed current is used for electrical stimulation, and the pulse width is 1 ms. Stimulation intensity is set at 90% of the motor threshold (the intensity at which weak contraction of the attached peripheral nerve-governing muscle is obtained), and the stimulation frequency is 20 Hz. The stimulation cycle is 2 seconds on/4 seconds off, and the stimulation duration is 20 minutes.
Interventions/Control_2
Sham Stimulation Group
In the sham stimulation group, electrodes are applied as in the peripheral sensory stimulation group, but no peripheral sensory stimulation is performed, and the subjects are placed in a sitting position for 20 minutes. The subjects are verbally informed that the sham stimulation is a peripheral sensory stimulation intervention of imperceptible intensity.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are eligible.
(1) Age: Patients who are at least 20 years old and less than 805 years old at the time of obtaining consent.
(2) Gender: Any gender
(3) Inpatient/outpatient: Inpatient
(4) Patients with somatosensory and motor dysfunction in the upper and lower limbs due to cerebrovascular disease
(5) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
Key exclusion criteria
Patients who fall under any one of the following categories are excluded from the study.
(1) Patients who have a pacemaker or other stimulating device in their body.
(2) Patients with acute symptom changes such as worsening motor or sensory paralysis.
(3) Patients who are unable to follow the examiner's instructions due to decreased level of consciousness or dementia (patients with an HDS-R score of 20 or less are excluded).
(4) Patients with a history of epilepsy
(5) Pregnant, lactating, possibly pregnant, or wishing to become pregnant during the study period.
(6) Those who are unable to perform the evaluation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiraku |
| Middle name | |
| Last name | Watanabe |
Organization
University of Fukui hospital
Division name
Division of rehabilitation
Zip code
910-1193
Address
University of Fukui Hospital, 23-3, Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776-61-3111
hiraku@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Hiraku |
| Middle name | |
| Last name | Watanabe |
Organization
University of Fukui hospital
Division name
Division of rehabilitation
Zip code
910-1193
Address
University of Fukui Hospital, 23-3, Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776-61-3111
Homepage URL
hiraku@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui hospital
Address
University of Fukui Hospital, 23-3, Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
Tel
0776-61-3111
hiraku@u-fuku.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
福井大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | 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 | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064330
