A Functional Near- Infrared Spectroscopy Study on the Bra... | NCT07509944

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

May 1, 2030Estimated

Completion Date

Oct 1, 2030Estimated

First Submitted Date

May 6, 2025

First Submission Date that Met QC Criteria

Mar 29, 2026

First Posted Date

Apr 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2026

Last Update Posted Date

Apr 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

After the selected patients are determined, the researchers of this study need to have full communication with the patients. The location is the rehabilitation ward of our hospital and the time is

Before joining the group. During this process, the patient should be informed of the purpose, procedures and processes of the trial. The informed consent form should be signed by the patient himself/herself. Such as the patient

Illiterate, the informed consent process was witnessed by an independent witness and signed. The subject pressed their fingerprint at the signature. In the study process fully

Listen to and respond to the questions and opinions of the subjects or their representatives.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
normal hand movement			Behavioral: healthy hand movement
mirror hand movement			Device: mirror image

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mirror image	Device	Patients will be asked to place the affected hand in the mirror box. While quickly opening and closing the healthy hand, they should observe the reflection of the healthy hand in the mirror and imagine the affected hand doing the same movements.

Measure	Description	Time Frame
fNIRS measured brain activation		The measurement of the primary outcome indicators occurred after the patients had received one week of hand function rehabilitation training.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

It meets the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Cerebrovascular Diseases in China", and is diagnosed as cerebral infarction or cerebral hemorrhage by CT or MRI.
The first stroke occurred;
The muscle strength of the flexor and extensor muscles of the affected finger is ≤ grade 1.
Right-handed player
Muscle tone improvement: Asworth level 2 or below;
The disease course is within 6 months and the condition is stable.
Age: 18 to 75 years old, with normal vision and hearing or corrected to normal.

Exclusion Criteria:

Those with an MMSE score less than 20, severe memory, communication and speech command comprehension disorders, and those who cannot cooperate with examinations and treatments;
Those with a history of epilepsy;
Those with a history of stroke, traumatic brain injury or brain tumor in the past;
Those with peripheral nervous system injuries other than stroke as diagnosed by imaging;
Those with visual spatial impairments such as visual field defects and unilateral neglect;
Skull defect or metal bone plates
For those who are not suitable for functional near-infrared examination;
Those with a history of intracranial surgery.
Patients with lesion areas in the cerebellum or brainstem.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

The main population of this study consists of individuals aged between 30 and 80 years old who have experienced a stroke for the first time and have residual upper limb dysfunction. There is no limit to the age range.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiasheng Zhu, Bachelor's	Contact	+86 15157177433		zhujiasheng321@sina.com
Yifei Xia, master's	Contact	+86 19816890266		2523084@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Zhejiang University School of Medicine	Recruiting	Hangzhou			China

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases