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

Sponsor
Fu Xing Hospital, Capital Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04944680
Collaborator
(none)
80
1
4
35.7
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Transcranial Direct Current Stimulation therapy
  • Behavioral: Motor imagery therapy
  • Behavioral: Transcranial Direct Current Stimulation and motor imagery therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel 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.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.
Masking:
Double (Care Provider, 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.
Primary Purpose:
Treatment
Official Title:
Effects of Transcranial Direct Current Stimulation and Motor Imagery for the Recovery of Upper Limb Function of Stroke Patients
Actual Study Start Date :
Jun 9, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

Stroke patients accept the traditional rehabilitation alone.

Active Comparator: Transcranial Direct Current Stimulation group

Stroke patients accept the Transcranial Direct Current Stimulation alone.

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.

Active Comparator: Motor imagery group

Stroke patients do the motor imagery alone.

Behavioral: 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.

Experimental: Transcranial Direct Current Stimulation and motor imagery group

Stroke patients accept the Transcranial Direct Current Stimulation and do the motor imagery at the same time.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Behavioral assessment by Fugl-Meyer Assessment for Upper Limb [Baseline]

    Complete the scale at baseline

  2. 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.

  3. Behavioral assessment by Action Research Arm Test [Baseline]

    Complete the above scale at baseline

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fu Xing Hospital, Capital Medical University Beijing Beijing China 100000

Sponsors and Collaborators

  • Fu Xing Hospital, Capital Medical University

Investigators

  • Study Director: Lirong Huo, Doctor, Office of academic research, Fu Xing Hospital, Capital Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ran Li, Doctor Li, Fu Xing Hospital, Capital Medical University
ClinicalTrials.gov Identifier:
NCT04944680
Other Study ID Numbers:
  • 2021FXHEC-KSKY002
First Posted:
Jun 29, 2021
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022