Dual Channel Rehabilitation Technology Promotes Rapid Recovery of Upper Limbs After Stroke

Not Applicable

• Conditions: Transcranial Direct Current Stimulation; Image, Body; Stroke; Upper Extremity Dysfunction

• Registration Number: NCT04944680
• Lead Sponsor: Fu Xing Hospital, Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-09
• Study First Submitted: 2021-06-12
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Behavioral assessment by Action Research Arm Test	Baseline	Complete the above scale at baseline
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb	Baseline	Complete the scale at baseline
Motor network change	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	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	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	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	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	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.

Trial Locations

Locations (1)

Fu Xing Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China