Cortex Motor Function Reorganization in Stroke Patients

NCT04794673 | Completed

• 1 other identifier: LY-81825105
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

In China, stroke is among the highest morbidity and mortality, especially in senile population. Most of those patients had survived with various degrees of cerebral dysfunction; among them about 50% were motor deficit. Previous in vitro studies indicated that recovery of motor function after stroke were related not only to axonal regeneration or synapse reformation, but also functional reorganization of adjacent areas and other functional associated areas. The previous fMRI studies shown that the cerebral motor cortex possess the natural ability of self compensation and self reorganization in the situation of brain damage. It was characterized by equally bilateral activation in acute stage to partial ipsilateral activation and major contralateral activation in subacute stage to contralateral activation in chronic stage. We plan to recruit first-episode acute cerebral infarction patients with single lesion on middle cerebral artery supply area and age and sex matched healthy volunteers. All the patients are going to assess in three different sessions (V1, 3 days after the onset of complaint, V2,30 days after onset of complaint; V3, 90 days after onset of the complaint ) with both clinical check as well as fMRI scan. The clinical assessment including dynamometer and finger tapping test to evaluate the strength and the flexibility of each upper legs and it also included the corresponding scales to exclude poststroke dementia and moderate and serious poststroke depression. The fMRI is scanned by using bilateral arm motor tasks. Motor cortex activation regions, activation of voxel between healthy controls and patients in different checkpoint are collected. The purpose of this study is to investigate the dynamic process of motor cortical functional reorganization after cerebral stoke using functional magnetic resonance imaging combined with the behavior assessment. Meanwhile，we also studied the differences of motor function recovery and motor cortex compensation between dominant hemisphere and non-dominant hemisphere after stroke. Therefore, we could provide a theoretical basis and build up a useful evaluation system for rehabilitation after stroke and other arious cerebral injury.

Conditions

Ischemic Stroke

Keywords

motor cortex reorganization, Ischemic Stroke, fMRI, BOLD

Outcome Measures

Primary Outcomes (2)

• A change of outcome measure: Index finger tapping test

  The primary measure is the number of clicks that one index finger makes on the mouse as quickly as possible in 10 seconds.The subject took a sitting position and tapped the mouse with his index finger to record the fastest number of taps within 10 seconds.

  This is an outcome measure to assess the improvement of motor function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.

• A change of outcome measure: The maximum hand grip strength test

  Grip dynamometer(Beijing xintong sport equipment co. LTD, WCS-99.9 digital display electric the child dynamometer), in kilograms. To facilitate the maximum grip strength of one hand, the patient may place the arm in any position during the measurement, no body contact, elbows may be flexed or extended.

  This is an outcome measure to assess the improvement of motor function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the 3 days (V1), 30days (V2), and 90 days (V3) after randomization.

Secondary Outcomes (5)

• A change of outcome measure: Functional Magnetic Resonance Imaging(fMRI)

  We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.

• National Institute of Health stroke scale(NIHSS )

  In order to ensure that participants can cooperate with our study, this assessment will be performed before randomization.

• Follow-up measurement: Hamilton Depression Rating Scale (HAMD)

  We must determine that the participant is not in depression at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.

• Follow-up measurement: Hamilton Anxiety Rating Scale (HAMA)

  We must determine that the participant is not in anxiety at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.

• Follow-up measurement: Mini-Mental State Examination (MMSE)

  We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the 3 days (V1), 30 days (V2), and 90 days (V3) after randomization.

Study Arms (3)

Left damage

Have the brain damage and the location of the damage in the left brain

Other: brain damage

Right damage

Have the brain damage and the location of the damage in the right brain

Other: brain damage

Nomal control

Not have the brain damage

Other: brain damage

Interventions

brain damage OTHER

Have or not have the brain damage and the location of the damage

Left damage; Nomal control; Right damage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to recruite first-episode acute cerebral infarction patients with single lesion on middle cerebral artery supply area and age and sex matched healthy volunteers.

You may qualify if:

• The first onset, the lesion was the single lesion of infarction or hemorrhage confirmed by head Magnetic Resonance Imaging(MRI) or Computed Tomography(CT).
• Hemiplegic hand muscle strength above grade 3, and was able to cooperate with the stimulation task of f MRI examination.
• According to the Edinburgh Handedness Questionnaire (EHQ) as the right hand.
• According to the commonly used eye chart examination, the naked eye vision \>4.9.
• There is no central nervous system organic disease and other motor diseases that can affect hand function.
• No previous long-term alcoholism and long-term use of central nervous system activity and other drugs treatment.
• No contraindication to MRI scan.
• The patient cooperated with the examination and the patient or their guardian signed an informed consent.

You may not qualify if:

• Previous diseases of the central nervous system and peripheral nervous system that significantly affected the motor function of limbs.
• Significant cognitive impairment, MMSE≤27.
• Subjects was engaged in professional music playing or keyboard operation before illness.
• The level of consciousness drops after the illness.
• Significant anxiety and depression status (Hamilton anxiety scale ≥14 points, Hamilton depression scale ≥13 points) and other mental illness and history.
• Aphasia and neglect.
• History of epilepsy
• History of drug dependence
• Liver dysfunction, renal dysfunction, heart failure or other important organ function loss compensation
• Contraindication to MRI scan.
• Refuse to provide written consent or fail to cooperate with inspection for other reasons.

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

General Hospital of Southern Theatre Command,PLA

Guangzhou, Guangdong, 510010, China

Location

Related Publications (31)

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MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yan LIU, PhD

  Guangzhou General of Guangzhou Military Command

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department director

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: January 12, 2020
• Primary Completion: August 12, 2020
• Study Completion: August 30, 2020
• Last Updated: March 12, 2021

Record last verified: 2020-03

Locations

CN (1)