UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049799 |
|---|---|
| Receipt number | R000056717 |
| Scientific Title | Effects of transcranial alternating current stimulation over the parietal lobes in verbal associative memory |
| Date of disclosure of the study information | 2022/12/16 |
| Last modified on | 2025/06/02 12:10:22 |
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Basic information
Public title
Effects of transcranial alternating current stimulation over the parietal lobes in verbal associative memory
Acronym
Effects of transcranial alternating current stimulation over the parietal lobes in verbal associative memory
Scientific Title
Effects of transcranial alternating current stimulation over the parietal lobes in verbal associative memory
Scientific Title:Acronym
Effects of transcranial alternating current stimulation over the parietal lobes in verbal associative memory
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of transcranial alternating current stimulation over the parietal lobes in verbal associative memory task
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Verbal associative memory performance will be assessed 1 day and 7 days after the end of transcranial alternating current stimulation.
Evaluation items: performance on the recongnition task
1. Percentage of correct responses
2. Reaction time for correct responses
3. Persentage of error
4. d-prime score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transcranial alternating current stimulation to the left parietal lobe
Interventions/Control_2
Sham stimulation to the left parietal lobe
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
| 19 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Native Japanese speaker
2.Non-smokers
3. Right-handed healthy adults
4. Normal or corrected vision
5. No history of neurological trauma or mental disorder
Key exclusion criteria
1. History of previous head injury
2. Metal implants in the head
3. History of epileptic seizures
4. History of psychotropic drug use
5. Depressive tendencies (self-rated depression scale of 45 points or more)
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | SHUNXIANG |
| Middle name | |
| Last name | SUN |
Organization
Graduate School Niigata University of Health and Welfare
Division name
Major in Medical and Rehabilitation Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL
0252574554
hom22003@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Nomura |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
TEL
0252574554
Homepage URL
nomura@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Ethical review board of Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
0252574554
rinri@nuhw.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
新潟医療福祉大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s00221-025-07009-8
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s00221-025-07009-8
Number of participants that the trial has enrolled
28
Results
The results revealed a significant difference in the number of correct responses between the interventions on day 7 and day 28. These data suggest that gamma-frequency tACS stimulation of the left PPC enhances the long-term retention of AM in healthy adults.
Results date posted
| 2025 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Overall, 28 healthy adults (male, 18; female, 10) were included in this study. The mean age+/-standard deviation (SD) of the participants was 22.5 +/- 1.2 years, and the mean years of education+/-SD was 16.8+/-1.0 years. All participants were identified as right-handed with a score of 0.8-1.0 according to the Edinburgh Handedness Test Index. The participants were randomly assigned to the tACS group (n=14; female, 6) or the sham stimulation group (n = 14; female, 4). All the participants provided written informed consent before participating in this study.
Participant flow
The experiment was conducted over three sessions on days 1, 7, and 28. During the learning phase on day 1, three blocks were included. Each block consisted of an encoding task and a cued recall task using the same set of 50 word pairs. The participants were instructed to recall as many word pairs as possible. Following the three blocks, there was a 2-min break, followed by a 2-min distraction task, which was a sequential subtraction task. This was followed by a recall task, which was repeated on days 7 and 28. Across all sessions, the participants performed the same version of the cued recall task to recall the initial lists from the learning phase. The participants received stimulation (tACS or sham stimulation) during the day 1 encoding task.
Adverse events
In the tACS group, four participants experienced mild itch- ing. In the sham group, two participants experienced mild itching. All six participants reported that the sensation only occurred at the beginning of the stimulation and disappeared over time. No significant neurosensory side effects were noted.
Outcome measures
the number of correctly recalled words on days 1, 7, and 28
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2022 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056717
