UMIN-ICDS Clinical Trial

Public title

Research on Neuromodulation and Psychological Modulation Techniques for Improving Sports Performance

Acronym

Research on Neuromodulation and Psychological Modulation Techniques for Improving Sports Performance

Scientific Title

Research on Neuromodulation and Psychological Modulation Techniques for Improving Sports Performance

Scientific Title:Acronym

Research on Neuromodulation and Psychological Modulation Techniques for Improving Sports Performance

Region

Japan

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

While numerous methods for physical conditioning have been proposed to help athletes achieve peak performance, the methods for modulating brain function remain unclear. Furthermore, in recent years, techniques such as non invasive direct electrical stimulation of the brain have been proposed as methods for modulating human brain function. However, it is not yet clear how these techniques affect athletic performance. This study aims to improve athletes performance by regulating brain function. Specifically, it seeks to understand the mechanisms underlying brain function regulation through electrophysiological and psychological methods and to clarify the effects of these methods on performance.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Perform a motor learning task (reaching task) and evaluate it based on the learning rate.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

taVNS stimulation is performed using the taVNS stimulator (Soterix Medical) or the neuroStym tES stimulator (Neuro Device). Stimulation parameters are based on the protocol by Badran et al., with the stimulation intensity set at twice the sensory threshold (or an intensity of 5 mA or less) (Badran et al., 2018).

Interventions/Control_2

Sham stimulation is performed using the taVNS stimulator (Soterix Medical) or the neuroStym tES stimulator (Neuro Device).

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

The study will include healthy men and women (including athletes) aged 18 to 60. Participants must confirm that they have no objections to having their physiological parameters measured.

Key exclusion criteria

Under the conditions for administering noninvasive stimulation, the following individuals shall be excluded:
The following subjects shall be excluded: those with metal or metal plates in the neck or higher; those with a pacemaker or implantable pump; those with a history of craniotomy; those with cardiovascular or pulmonary disorders; those with autonomic nervous system disorders; those with musculoskeletal injuries or significant sequelae that would interfere with the study; those with skin lesions at the stimulation site; and those with a history of epilepsy.

Target sample size

100

Name of lead principal investigator

1st name	Rieko
Middle name
Last name	Osu

Organization

Waseda university

Division name

Faculty of Human Sciences

Zip code

3591165

Address

Room 205, Frontier Research Center (Building 110), School of Human Sciences, Waseda University, 135-1 Horinouchi, Tokorozawa City, Saitama Prefecture

TEL

0429476848

Email

r.osu@waseda.jp

Name of contact person

1st name	Riku
Middle name
Last name	Nakazato

Organization

Waseda university

Division name

Faculty of Human Sciences

Zip code

3591165

Address

110-205, Waseda University, 135-1 Horinouchi, Tokorozawa City, Saitama Prefecture

TEL

08057517805

Homepage URL

Email

physeter.newt@gmail.com

Institute

Waseda University

Institute

Department

Personal name

Organization

NTT Communication Science Laboratories

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Waseda University Office of Research Ethics

Address

1-104 Totsuka-cho, Shinjuku-ku, Tokyo 169-8050

Tel

0352721639

Email

rinri@list.waseda.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

早稲田大学（埼玉県）

Date of disclosure of the study information

2026

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

02

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

11

Month

10

Day

Last modified on

2026

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072678