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Clinical Trials/NCT04944680
NCT04944680
Unknown
Not Applicable

Effects of Transcranial Direct Current Stimulation and Motor Imagery for the Recovery of Upper Limb Function of Stroke Patients

Fu Xing Hospital, Capital Medical University1 site in 1 country80 target enrollmentJune 9, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Fu Xing Hospital, Capital Medical University
Enrollment
80
Locations
1
Primary Endpoint
Behavioral assessment by Action Research Arm Test
Last Updated
3 years ago

Overview

Brief Summary

The injury and remodeling mechanism about upper extremity motor network after stroke is not clear. There are few studies on the motor network covering cortex, white matter and blood perfusion at the time. Some studies have shown that metal imagery activates the cortex through active mental simulation. Our previous study has shown that passive application of transcranial direct current stimulation causes subthreshold polarization and promotes the effective integration of residual brain high-level network. This study proposes a hypothesis: transcranial Direct Current Stimulation + Motor Imagery combines active and passive neuromodulation techniques to produce dual channel effect, which can synergistically excite motor cortex, remodel the motor network and optimize cerebral perfusion. The research contents include clarify the effect of transcranial Direct Current Stimulation + Motor Imagery neuromodulation therapy through comprehensive randomized controlled trial study; present the process of brain injury and secondary neural plasticity through the motor network construction, functional connectivity strength and cerebral perfusion with Blood Oxygen Level Dependent, Diffusion Tensor Imaging and Arterial Spin Labeling multimodal magnetic resonance technology; calculate the correlation between motor score and brain functional network, extract the key nodes that can promote the motor network remodeling. The research results are expected to provide preliminary theoretical foundations for further research on the injury and remodeling mechanism about upper extremity motor network after stroke.

Registry
clinicaltrials.gov
Start Date
June 9, 2021
End Date
June 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fu Xing Hospital, Capital Medical University
Responsible Party
Principal Investigator
Principal Investigator

Ran Li

Doctor Li

Fu Xing Hospital, Capital Medical University

Eligibility Criteria

Inclusion Criteria

  • First stroke with upper limb motor dysfunction
  • No rapid natural recovery in the last week
  • Greater than 1 month since stroke onset
  • Pass the motor imagery test

Exclusion Criteria

  • Severe cognitive disorder
  • Severe spasm or joint contracture
  • Mental implants in vivo
  • Do not sign the informed consent

Outcomes

Primary Outcomes

Behavioral assessment by Action Research Arm Test

Time Frame: Baseline

Complete the above scale at baseline

Behavioral assessment by Fugl-Meyer Assessment for Upper Limb

Time Frame: Baseline

Complete the scale at baseline

Motor network change

Time Frame: Immediately after intervention

Change from baseline motor network immediately after intervention is obtained by subtracting the baseline from the later network strength, global efficiency and local efficiency.

Cerebral perfusion calculation

Time Frame: Baseline

The volume of interest covers the motor related territory including bilateral primary motor cortices, supplementary motor cortices, premotor cortices, thalami and cerebellums et al. The mean Cerebral Blood Flow value is calculated. The software used is Function Tool.

Behavioral assessment by Fugl-Meyer Assessment for Upper Limb change

Time Frame: Immediately after intervention

Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Fugl-Meyer Assessment score.

Behavioral assessment by Action Research Arm Test change

Time Frame: Immediately after intervention

Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Action Research Arm Test score.

Cerebral perfusion change

Time Frame: Immediately after intervention

Change from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.

Motor network construction

Time Frame: Baseline

Construct the motor network with the bilateral primary motor cortices, supplementary motor cortices, premotor cortices, thalami and cerebellums et al. as the nodes of the network. Motor network analysis consists the network strength, global efficiency and local efficiency. The software used is PANDA and GRETNA.

Study Sites (1)

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