UMIN-ICDS Clinical Trial

Public title

Neurophysiological Characteristics of Associated Reactions in Stroke Patients

Acronym

Neurophysiological Characteristics of Associated Reactions in Stroke Patients

Scientific Title

Neurophysiological Characteristics of Associated Reactions in Stroke Patients

Scientific Title:Acronym

Neurophysiological Characteristics of Associated Reactions in Stroke Patients

Region

Japan

Condition

Stroke (cerebral infarction or intracerebral hemorrhage); healthy adults (comparison groups)

Classification by specialty

Neurology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the neurophysiological characteristics of associated reactions after stroke, by comparing muscle activity arising on the contralateral side and neurophysiological measures when the effort level of unilateral voluntary contraction is varied, among patients with hemiparesis after stroke, young healthy adults, and older healthy adults.

Basic objectives2

Others

Basic objectives -Others

To clarify the neurophysiological characteristics of associated reactions after stroke.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Corticomuscular coherence (CMC) calculated from EEG and EMG of the contralateral limb during isometric contraction tasks

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Stroke group: Participants perform isometric elbow flexion and knee extension of the non-paretic side at 30%, 50%, and 70% of maximum voluntary contraction (MVC) (condition order randomized for each participant; 20 trials per condition; torque increased over approximately 2-3 s and held for 6 s; 60-s rest between trials), with simultaneous EEG and EMG recording. In addition, a voluntary matching task (20 trials) is performed, in which participants voluntarily activate the paretic muscle (biceps brachii or rectus femoris) to match the EMG amplitude of the associated reaction elicited under the 70% MVC condition. Measurements are divided over 3 days (day 1: assessments; day 2: elbow flexion task; day 3: knee extension task) and completed within 1 week after consent.

Interventions/Control_2

Young healthy group: Participants perform isometric elbow flexion and knee extension of the non-dominant side at 30%, 50%, and 70% MVC (order of tasks and conditions randomized for each participant; 20 trials per condition; torque increased over approximately 2-3 s and held for 6 s; 30-s rest between trials), with simultaneous EEG and EMG recording. Measurements are completed in 1 day (approximately 140 min including rest).

Interventions/Control_3

Older healthy group: Participants perform isometric elbow flexion and knee extension of the non-dominant side at 30%, 50%, and 70% MVC (order of tasks and conditions randomized for each participant; 20 trials per condition; torque increased over approximately 2-3 s and held for 6 s; 30-s rest between trials), with simultaneous EEG and EMG recording. Measurements are completed in 1 day (approximately 140 min including rest).

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

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

[Stroke group]
1) Aged 60 to 85 years
2) Hemiparesis of the upper and lower limbs due to a first-ever unilateral supratentorial cerebral infarction or intracerebral hemorrhage
3) At least 1 month after stroke onset
4) Stable general condition
5) Able to understand the study explanation and task instructions and to perform the tasks
6) Able to participate in measurements of up to approximately 100 min per day, including rest
7) Medical clearance for study participation obtained from the attending physician (or the full-time physician at the geriatric health services facility)
[Young healthy group]
[Stroke group]
1) Aged 60 to 85 years
2) Hemiparesis of the upper and lower limbs due to a first-ever unilateral supratentorial cerebral infarction or intracerebral hemorrhage
3) At least 1 month after stroke onset
4) Stable general condition
5) Able to understand the study explanation and task instructions and to perform the tasks
6) Able to participate in measurements of up to approximately 100 min per day, including rest
7) Medical clearance for study participation obtained from the attending physician (or the full-time physician at the geriatric health services facility)
[Young healthy group]
1) Healthy individuals aged 18 to 30 years
2) Right-handed according to the Edinburgh Handedness Inventory
3) Right-footed according to the Waterloo Footedness Questionnaire-Revised
[Older healthy group]
1) Healthy individuals aged 60 to 85 years
2) Right-handed according to the Edinburgh Handedness Inventory
3) Right-footed according to the Waterloo Footedness Questionnaire-Revised

Key exclusion criteria

[Stroke group]
1) Mini-Mental State Examination (MMSE) score of 20 or less recorded in the medical record, or judged to have difficulty sufficiently understanding the study explanation or task instructions due to aphasia or other higher brain dysfunction
2) Respiratory or cardiovascular disease that makes it difficult to perform the motor tasks safely
3) Limitation in range of motion that affects task performance
4) Persistent or repetitive involuntary movements of the limbs or trunk at rest that are judged to affect EEG or EMG recording or analysis
5) Botulinum toxin injection into the upper or lower limb, including the target muscles, within 4 months before the date of consent
[Young and older healthy groups]
1) Central nervous system, neuromuscular, or orthopedic disease that affects task performance or neurophysiological assessment
2) Respiratory or cardiovascular disease that makes it difficult to perform the motor tasks safely
3) Use of central nervous system-acting drugs that may affect neurophysiological assessment
4) Current psychiatric disorder that makes study participation or task performance difficult
5) Currently engaged, or engaged within the past year, in specialized or competitive training in a specific sport (training at least 3 times per week for a cumulative period of at least 1 year, or activity as a competitive athlete)

Target sample size

75

Name of lead principal investigator

1st name	Tomofumi
Middle name
Last name	Yamaguchi

Organization

Kyoto University

Division name

Department of Human Health Sciences, Graduate School of Medicine

Zip code

606-8507

Address

53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan

TEL

075-751-3963

Email

yamaguchi.tomofumi.3i@kyoto-u.ac.jp

Name of contact person

1st name	Tomofumi
Middle name
Last name	Yamaguchi

Organization

Kyoto University

Division name

Department of Human Health Sciences, Graduate School of Medicine

Zip code

606-8507

Address

53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan

TEL

075-751-3963

Homepage URL

Email

yamaguchi.tomofumi.3i@kyoto-u.ac.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Kyoto University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan

Tel

075-366-7618

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

15

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

10

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

11

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 related information

Registered date

2026

Year

10

Month

02

Day

Last modified on

2026

Year

10

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072276