UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054365 |
|---|---|
| Receipt number | R000062001 |
| Scientific Title | The examination of the influence of different movement patterns on sensory processing |
| Date of disclosure of the study information | 2024/05/11 |
| Last modified on | 2024/05/10 16:14:40 |
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Basic information
Public title
The examination of the influence of different movement patterns on sensory processing
Acronym
the examination of sensory systems
Scientific Title
The examination of the influence of different movement patterns on sensory processing
Scientific Title:Acronym
the examination of sensory systems
Region
| Japan |
Condition
Condition
Patients eligible for this study are those experiencing symptoms indicative of peripheral neuropathy, such as those resulting from conditions like stroke, carpal tunnel syndrome, and ulnar nerve entrapment.
Classification by specialty
| Surgery in general | Orthopedics | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The cerebral cortex is intricately involved in both somatosensation and locomotion, with nerve fibers connecting these functions. Neurophysiological studies indicate that peripheral nerve stimulation during voluntary movements can modulate brain responses (a phenomenon known as gating).
This study explores whether combining various exercises with sensory stimulation can enhance rehabilitation effectiveness for patients with sensory impairments resulting from stroke or peripheral neuropathy. We aim to validate sensory impairment rehabilitation through behavioral evaluation methods and brain function analysis, providing scientific evidence for its efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, we compare brain magnetic field responses evoked by peripheral electrical stimulation across different motion conditions: no motion, right hand motion, and left hand motion. We utilize the equivalent current dipole estimation method for analysis, considering dipoles with a goodness of fit (GOF) of 80% or higher for bilateral primary somatosensory sensations.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Selection Criteria
Healthy adults or individuals with a history of stroke, elbow tunnel syndrome, or carpal tunnel syndrome.
Patients without serious diseases or conditions necessitating surgery.
Participants able to engage in the study at Hiroshima University.
Patients under 80 years old at the time of study consent.
Individuals capable of providing written, voluntary consent to participate in the study.
Key exclusion criteria
Exclusion Criteria:
Patients under 18 years old or over 80 years old at the time of consent.
Patients with serious illnesses or conditions requiring surgery.
Individuals unable to participate in the study at Hiroshima University.
Patients unable to provide written, voluntary consent for participation in the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Sunagawa |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima, 734-8551, Japan
TEL
082-257-5455
torusuna@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Nakagawa |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima, 734-8551, Japan
TEL
082-257-5406
Homepage URL
keinakag@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Hiroshima University hospital IRB
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan
Tel
082-257-5596
hugcp@hiroshima-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 11 | 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 | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All participants will engage in the following seven motor tasks within a shielded room at the Magnetoencephalography Facility of Hiroshima University Hospital. During these tasks, 120 electrical stimuli will be applied to the median nerve to assess somatosensory processing.
Next, brain magnetic field responses evoked by median nerve stimulation will be averaged and compared across different exercise conditions: no exercise, right hand exercise, and left hand exercise.
Motor Tasks:
Place a ball on the palm of the right hand.
Grasp the ball with the right hand at 20% force.
Grasp the ball with the right hand at 40% force.
Grasp the ball with the right hand at 60% force.
Grasp the ball with the left hand at 20% force.
Grasp the ball with the left hand at 40% force.
Grasp the ball with the left hand at 60% force.
Management information
Registered date
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062001
