UMIN-ICDS Clinical Trial

Public title

Longitudinal Study of EEG Activity and Brain Network Changes During Recovery After Brain Injury

Acronym

Brain injury EEG study

Scientific Title

Longitudinal Analysis of Low-Frequency Brain Activity, Functional Connectivity, and Neural Dynamics During Recovery in Patients With Brain Injury

Scientific Title:Acronym

Brain Injury EEG study

Region

Japan

Condition

Patients who have suffered a first stroke

Classification by specialty

Neurology	Neurosurgery	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to use resting-state EEG to longitudinally elucidate changes in low-frequency brain activity and intracerebral network dynamics during the post-stroke recovery process.

Basic objectives2

Others

Basic objectives -Others

We will evaluate post-stroke pathophysiology from the perspective of neural network dynamics using low-frequency activity density, activity characteristics by frequency band, functional connectivity, and metastability-related indices derived from resting-state EEG. In addition, we aim to examine the associations between these EEG indicators and clinical severity, motor and cognitive function, activities of daily living, and late-stage symptoms, with the goal of identifying candidate biomarkers that reflect individual differences in recovery that cannot be fully explained by the location of brain damage alone.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Sleep-like slow-wave density and frequency during wakefulness, and low-frequency connectivity

Key secondary outcomes

1/f Slope (E/I Balance)
Basic Characteristics: Age, Sex, Diagnosis, Medical History, Comorbidities, and Days Since Onset
Brain Imaging Data and Clinical Imaging Reports, if Available
Modified Rankin Scale (mRS)
Post-Stroke Cognitive Screening: Oxford Cognitive Screen (OCS)
Cognitive Function: Montreal Cognitive Assessment-Japanese Version (MoCA-J)
Motor Function: Fugl-Meyer Assessment for the Upper and Lower Extremities (FMA)
Hemispatial Neglect: Star Cancellation Test and Line Bisection Test
Activities of Daily Living: Functional Independence Measure-Motor and Cognitive Subscales (FIM-Motor and FIM-Cognitive)
Fatigue Severity: Fatigue Severity Scale-7 (FSS-7)
Sleep Quality: Japanese Version of the Pittsburgh Sleep Quality Index (PSQI-J)
Depressive Symptoms: Japanese Version of the Patient Health Questionnaire-9 (PHQ-9)
Pain: Douleur Neuropathique 4 Questions (DN4)
Upper Limb Muscle Strength: Grip Strength
Gait Ability: 10-Meter Walking Speed

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

18

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients with a first stroke, defined as having mild to moderate symptoms (Japanese modified Rankin Scale [mRS] scores of 1, 2, or 3) or severe symptoms (Japanese mRS scores of 4 or 5), who are able to remain seated for at least 15 minutes

Key exclusion criteria

Participants who did not provide consent for the study, those who had received pharmacological sedation within the past 24 hours, those with psychiatric disorders, or those with cerebellar lesions

Target sample size

100

Name of lead principal investigator

1st name	Mitsuru
Middle name
Last name	Konita

Organization

Graduate School of Health Sciences, Kio University

Division name

Department of Rehabilitation Studies

Zip code

635-0832

Address

4-2-2 Mamichu, Koryo Town, Kitakatsuragi District, Nara Prefecture

TEL

0745-54-1601

Email

xiaorentianchong@gmail.com

Name of contact person

1st name	Mitsuru
Middle name
Last name	Konita

Organization

Graduate School of Health Sciences, Kio University

Division name

Department of Rehabilitation Studies

Zip code

635-0832

Address

4-2-2 Mamichu, Koryo Town, Kitakatsuragi District, Nara Prefecture

TEL

0745-54-1601

Homepage URL

Email

xiaorentianchong@gmail.com

Institute

Kio University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Graduate School of Health Sciences, Kio University

Address

4-2-2 Mamichu, Koryo Town, Kitakatsuragi District, Nara Prefecture

Tel

0745-54-1601

Email

xiaorentianchong@gmail.com

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

07

Month

17

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

06

Month

30

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

15

Day

Last follow-up date

2036

Year

07

Month

14

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Observational Study

Registered date

2026

Year

07

Month

11

Day

Last modified on

2026

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071195