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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04944680
• Other study ID #: 2021FXHEC-KSKY002
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: June 2024

Study information

• Verified date: August 2022
• Source: Fu Xing Hospital, Capital Medical University
• Contact: Ran Li, Doctor
• Phone: +86-010-88062907
• Email: liran817[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Transcranial Direct Current Stimulation therapy
Transcranial Direct Current Stimulation with two saline-soaked electrodes (5cm x 7cm) is applied by our occupational therapist. The anode is placed on the ipsilesional primary motor cortex (C3/C4). The cathode is placed on the contralesional shoulder. The current is 1.5 milliampere and lasts 20 minutes.
• Motor imagery therapy
Stroke patients are asked to watch a video about the upper extremity movement. The video lasts 20 minutes. The contents are as follows: the patients are asked to relax the muscles for the first 2 minutes; the action refers to shoulder flexion and extension, elbow flexion and extension, forearm pronation and supination, wrist flexion and extension, finger flexion and extension, and corresponding daily functional activities for 16min; the patients are asked to relax their mind and body for the last 2 minutes.
• Transcranial Direct Current Stimulation and motor imagery therapy
The treatment parameters are the same as the above. It should be emphasized that the participants sit and perform the motor imagery task while receiving Transcranial Direct Current Stimulation.

Locations

Country	Name	City	State
China	Fu Xing Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fu Xing Hospital, Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Kaneko F, Shibata E, Hayami T, Nagahata K, Aoyama T. The association of motor imagery and kinesthetic illusion prolongs the effect of transcranial direct current stimulation on corticospinal tract excitability. J Neuroeng Rehabil. 2016 Apr 15;13:36. doi: 10.1186/s12984-016-0143-8. — View Citation

Lee J, Lee A, Kim H, Shin M, Yun SM, Jung Y, Chang WH, Kim YH. Different Brain Connectivity between Responders and Nonresponders to Dual-Mode Noninvasive Brain Stimulation over Bilateral Primary Motor Cortices in Stroke Patients. Neural Plast. 2019 Apr 7;2019:3826495. doi: 10.1155/2019/3826495. eCollection 2019. — View Citation

Lioi G, Butet S, Fleury M, Bannier E, Lécuyer A, Bonan I, Barillot C. A Multi-Target Motor Imagery Training Using Bimodal EEG-fMRI Neurofeedback: A Pilot Study in Chronic Stroke Patients. Front Hum Neurosci. 2020 Feb 18;14:37. doi: 10.3389/fnhum.2020.00037. eCollection 2020. — View Citation

Marquez JL, Conley AC, Karayanidis F, Miller J, Lagopoulos J, Parsons MW. Determining the benefits of transcranial direct current stimulation on functional upper limb movement in chronic stroke. Int J Rehabil Res. 2017 Jun;40(2):138-145. doi: 10.1097/MRR.0000000000000220. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral assessment by Fugl-Meyer Assessment for Upper Limb	Complete the scale at baseline	Baseline
Primary	Behavioral assessment by Fugl-Meyer Assessment for Upper Limb change	Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Fugl-Meyer Assessment score.	Immediately after intervention
Primary	Behavioral assessment by Action Research Arm Test	Complete the above scale at baseline	Baseline
Primary	Behavioral assessment by Action Research Arm Test change	Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Action Research Arm Test score.	Immediately after intervention
Primary	Motor network construction	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.	Baseline
Primary	Motor network change	Change from baseline motor network immediately after intervention is obtained by subtracting the baseline from the later network strength, global efficiency and local efficiency.	Immediately after intervention
Primary	Cerebral perfusion calculation	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.	Baseline
Primary	Cerebral perfusion change	Change from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.	Immediately after intervention