UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056592 |
|---|---|
| Receipt number | R000064674 |
| Scientific Title | The effect of neuromodulation in post-stroke aphasia treatment |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2024/12/27 16:38:16 |
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Basic information
Public title
The effect of neuromodulation in post-stroke aphasia treatment
Acronym
The effect of neuromodulation in post-stroke aphasia treatment
Scientific Title
The effect of neuromodulation in post-stroke aphasia treatment
Scientific Title:Acronym
The effect of neuromodulation in post-stroke aphasia treatment
Region
| Japan |
Condition
Condition
post-stroke aphasia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aphasia is reported to occur in 25-45% of patients in the chronic phase of stroke (Flowers et al., 2016) and has a significant impact on quality of life. Speech-language therapy is the standard treatment for aphasia, but its effectiveness is limited. Reorganization of brain function is important for aphasia recovery (Saur et al., 2006). Repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation ( tDCS) have been studied as a combined treatment method. In particular, tDCS is rapidly gaining popularity because the equipment is less expensive and safer than rTMS. Stimulation with tDCS for patients with chronic aphasia has improved naming tasks and auditory comprehension (Baker et al., 2010; Wu et al., 2015). However, the stimulation conditions and sites are still under debate. In this study, we will examine the therapeutic effects of tDCS on aphasia using the Standardized Language Test for Aphasia (SLTA), a commonly used aphasia assessment in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SPECT, SLTA, Naming task, other speech and language test
Key secondary outcomes
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
1 session : 20min tDCS + speech and language therapy
1session per week
5session
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients between the ages of 18 and 90
2) Patients diagnosed with stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, cerebral vascular malformation)
3) Patients with aphasia symptoms and stable for at least 6 months after the onset of symptoms
4) Patients with no cognitive decline (eligible patients who can understand the explanation)
5) Patients with stable stroke symptoms
6) Patients who agree to pay the cost of the SPECT.
Key exclusion criteria
1) Patients with a history of epilepsy
2) Patients with a history of neuropsychiatric disorders
3) Patients with metal implants in the body (including pacemakers)
4) Patients with a history of serious arrhythmia or heart failure
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Shimmyo |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Rehabilitation Medicine
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3259
kshimmyo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Shimmyo |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Rehabilitation Medicine
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3259
Homepage URL
kshimmyo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical 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
Saitama Medical Center, Saitama Medical University
Address
1981 Kamoda, Kawagoe, Saitama, Japan
Tel
049-228-3259
kshimmyo@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | 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
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | 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 | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064674
