Clinical trial NCT04944680: Dual Channel Rehabilitation Technology Promotes Rapid Recovery of Upper Limbs After Stroke
Official title: Effects of Transcranial Direct Current Stimulation and Motor Imagery for the Recovery of Upper Limb Function of Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Upper Extremity Dysfunction
Transcranial Direct Current Stimulation
Image, Body
Lead sponsor: Fu Xing Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The four parallel groups are as follows: control group, Transcranial Direct Current Stimulation group, motor imagery group, Transcranial Direct Current Stimulation and motor imagery group. Patients are randomly assigned to each group with block randomization.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Behavioral assessment by Fugl-Meyer Assessment for Upper Limb
timeFrame: Baseline
measure: Behavioral assessment by Fugl-Meyer Assessment for Upper Limb change
timeFrame: Immediately after intervention
measure: Behavioral assessment by Action Research Arm Test
timeFrame: Baseline
measure: Behavioral assessment by Action Research Arm Test change
timeFrame: Immediately after intervention
measure: Motor network construction
timeFrame: Baseline
measure: Motor network change
timeFrame: Immediately after intervention
measure: Cerebral perfusion calculation
timeFrame: Baseline
measure: Cerebral perfusion change
timeFrame: Immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fu Xing Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Office of academic research, Fu Xing Hospital, Capital Medical University
name: Lirong Huo, Doctor
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: Lioi G, Butet S, Fleury M, Bannier E, Lecuyer 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.
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.