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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04944680
Enrollment
80
Registered
2021-06-29
Start date
2021-06-09
Completion date
2024-06-30
Last updated
2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALTranscranial 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.

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.

BEHAVIORALTranscranial 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.

Sponsors

Fu Xing Hospital, Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Because of the different therapies, it is not possible to mask the participant. It was possible to mask the group allocation for routine rehabilitation therapist. However, the difference is obvious between Transcranial Direct Current Stimulation and motor imagery. Outcome measure is conducted by a physician who is blinded to group assignment.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Behavioral assessment by Fugl-Meyer Assessment for Upper LimbBaselineComplete the scale at baseline
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb changeImmediately after interventionChange 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 TestBaselineComplete the above scale at baseline
Behavioral assessment by Action Research Arm Test changeImmediately after interventionChange from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Action Research Arm Test score.
Motor network constructionBaselineConstruct 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.
Motor network changeImmediately after interventionChange 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 calculationBaselineThe 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.
Cerebral perfusion changeImmediately after interventionChange from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.

Countries

China

Contacts

Primary ContactRan Li, Doctor
liran817@sina.com+86-010-88062907
Backup ContactYong Wang, Doctor
li20140821@yeah.net+86-010-88062908

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026