Scalp Acupuncture Combined rTMS on Brain White Matter Microstructure of Hemiplegic Patients With Stroke

NCT03117465 | Completed DMC

• 1 other identifier: SZSixth_001
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

To apply Bold-fMRI technology to observe and compare the differences of task-related activation of relevant brain cortex region in stroke hemiplegic patients and healthy subjects after finger grasping movement.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Bold-fMRI examination

  To observe and compare the differences of task-related activation of relevant brain cortex region in stroke hemiplegic patients and healthy subjects after finger grasping movement.

  changes of baseline and day 14 after treatment

Secondary Outcomes (1)

• Fugl-Meyer assessment

  changes of baseline and day 14 after treatment

Study Arms (2)

the experimental group

EXPERIMENTAL

Stroke hemiplegia patients are randomly assigned to the experimental group (scalp acupuncture + low frequency repetitive transcranial magnetic stimulation + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.

Other: the experimental group

the control group

OTHER

Stroke hemiplegia patients are randomly assigned to the control group (scalp acupuncture + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.

Other: the control group

Interventions

the experimental group OTHER

Stroke hemiplegia patients are randomly assigned to the experimental group (scalp acupuncture + low frequency repetitive transcranial magnetic stimulation + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.

the experimental group

the control group OTHER

Stroke hemiplegia patients are randomly assigned to the control group (scalp acupuncture + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.

the control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• at the same time in accordance with ischemic stroke of Chinese and western medicine diagnostic criteria;
• the first time stroke, unilateral stroke or once attack but not remnant nerve dysfunction;
• stable vital signs and clear consciousness;
• unilateral upper limb Brunnstrom evaluation;
• age from 30 to 60 years;
• the course of disease was within 1 year.

You may not qualify if:

• a history of epilepsy;
• the important organs function failed such as heart, lung, liver and kidney;
• serious cognitive impairment and poor compliance;
• wearing a pacemaker、intracranial metal implants, or with skull defects;
• serious cervical spine including cervical stenosis and instability of cervical spine;
• Women during pregnancy;
• patients cannot tolerate fMRI study.

Sponsors & Collaborators

• Shenzhen Sixth People's Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ning Zhao, Master

  Shenzhen Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: All the hemiplegic patients were mainly derived from stroke recovery periodical inpatients from September 2015 to September 2016 in rehabilitation unit of shenzhen nanshan district people's hospital, Guangdong Province,China. All subjects were told in detail about the risks and signed informed consent before the experiment.

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 18, 2017
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04