UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048274 |
|---|---|
| Receipt number | R000055011 |
| Scientific Title | Synchronized Application of Closed-loop NMES and Precision tACS in Post-Stroke Hand Rehabilitation |
| Date of disclosure of the study information | 2022/07/05 |
| Last modified on | 2025/05/22 17:39:43 |
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Basic information
Public title
Fatigue secondary to Occupational therapy combined with transcranial Alternation Current Stimulation
Acronym
TACS-fatigue
Scientific Title
Synchronized Application of Closed-loop NMES and Precision tACS in Post-Stroke Hand Rehabilitation
Scientific Title:Acronym
Synchronized Application of IVES and tACS study (SAITAC)
Region
| Japan |
Condition
Condition
Chronic Stroke with severe upper limb paresis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to check if rehabilitation treatment is feasible when combined with tACS in terms of fatigue
Basic objectives2
Others
Basic objectives -Others
Following to previously established tACS protocol, we aim to check if the fatigue was tolerable to the patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire
Muscular output during sessions
POMS2
Heart rate variability
Key secondary outcomes
Stroke impairment/functional assessments: SIAS, FMA, MAL-14, MAS, sensory assessments (SWMT, thumb localizing, 2-pt discrimination, tuning-fork)
Neurophysiology: EEG-change, Muscular output(detailed assessment with surface EMG), H-reflex and reciprocal inhibition, SEP
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
OT combined with Beta-tACS with the intensity of 1.1mA, for 20 min followed by OT single treatment for 40 min
Interventions/Control_2
In the control, only ramp up-down current will be applied through the same setting
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Gait and ADL independent
2. No remarkable cognitive problem
3. age between 20-80
4. chronic stage more than 6 month (180 days)
5. first-ever stroke presenting with hemi-paresis
6. SIAS finger score more than 1b
7. SIAS UE proximal score more than 2
8. No severe contracture
9. Outpatient rehab program possible
Key exclusion criteria
1. Cortical lesion
2. Post operative at brain or spinal cord
3. severe skin trouble
4. metal implant
5. Seizure
6. Medication that affect brain function
7. pregnancy
8. Adverse effect to tACS, tDCS or TMS
9. Severe internal organ issue
10. physical treatment impossible dues to inflammation or orthopaedic issue
11. severe cognitive problem
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Syoichi |
| Middle name | |
| Last name | Tashiro |
Organization
Kyorin university school of medicine
Division name
department of Rehabilitation Medicine
Zip code
1818611
Address
Shin-kawa 6-20-2, Mitaka city, Tokyo
TEL
0422-47-5511
s-tashiro@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Syoichi |
| Middle name | |
| Last name | Tashiro |
Organization
same
Division name
same
Zip code
1818611
Address
same
TEL
0422-47-5511
Homepage URL
s-tashiro@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Dept, Rehabilitation Medicine, Kyorin university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin university school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Nakatomi Fund. (NF-2022-R61)
General Insurance Association of Japan (22-1-037)
Daiwa Securities Health Fund. (49-2-4)
Education/Research Fund of Kyorin univ (S138010001)
IRB Contact (For public release)
Organization
Ethics committee of Kyorin university school of medicine
Address
Shinkawa 6-20-2, Mitaka city, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-uac.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
| 2022 | Year | 07 | Month | 05 | 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
| 2021 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On going
Management information
Registered date
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055011
