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

Primary Purpose

Stroke, Upper Extremity Dysfunction, Transcranial Direct Current Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation therapy
Motor imagery therapy
Transcranial Direct Current Stimulation and motor imagery therapy
Sponsored by
Fu Xing Hospital, Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fu Xing Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Experimental

Arm Label

Control group

Transcranial Direct Current Stimulation group

Motor imagery group

Transcranial Direct Current Stimulation and motor imagery group

Arm Description

Stroke patients accept the traditional rehabilitation alone.

Stroke patients accept the Transcranial Direct Current Stimulation alone.

Stroke patients do the motor imagery alone.

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

Outcomes

Primary Outcome Measures

Behavioral assessment by Fugl-Meyer Assessment for Upper Limb
Complete the scale at baseline
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.
Behavioral assessment by Action Research Arm Test
Complete the above scale at baseline
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.
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.
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.
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.
Cerebral perfusion change
Change from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.

Secondary Outcome Measures

Full Information

First Posted
June 12, 2021
Last Updated
August 2, 2022
Sponsor
Fu Xing Hospital, Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04944680
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Xing Hospital, Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Dysfunction, Transcranial Direct Current Stimulation, Image, Body

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Stroke patients accept the traditional rehabilitation alone.
Arm Title
Transcranial Direct Current Stimulation group
Arm Type
Active Comparator
Arm Description
Stroke patients accept the Transcranial Direct Current Stimulation alone.
Arm Title
Motor imagery group
Arm Type
Active Comparator
Arm Description
Stroke patients do the motor imagery alone.
Arm Title
Transcranial Direct Current Stimulation and motor imagery group
Arm Type
Experimental
Arm Description
Stroke patients accept the Transcranial Direct Current Stimulation and do the motor imagery at the same time.
Intervention Type
Behavioral
Intervention Name(s)
Transcranial Direct Current Stimulation therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motor imagery therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Transcranial Direct Current Stimulation and motor imagery therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb
Description
Complete the scale at baseline
Time Frame
Baseline
Title
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb change
Description
Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Fugl-Meyer Assessment score.
Time Frame
Immediately after intervention
Title
Behavioral assessment by Action Research Arm Test
Description
Complete the above scale at baseline
Time Frame
Baseline
Title
Behavioral assessment by Action Research Arm Test change
Description
Change from baseline Action Research Arm Test immediately after intervention is obtained by subtracting the baseline from the later Action Research Arm Test score.
Time Frame
Immediately after intervention
Title
Motor network construction
Description
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.
Time Frame
Baseline
Title
Motor network change
Description
Change from baseline motor network immediately after intervention is obtained by subtracting the baseline from the later network strength, global efficiency and local efficiency.
Time Frame
Immediately after intervention
Title
Cerebral perfusion calculation
Description
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.
Time Frame
Baseline
Title
Cerebral perfusion change
Description
Change from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.
Time Frame
Immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Li, Doctor
Phone
+86-010-88062907
Email
liran817@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Wang, Doctor
Phone
+86-010-88062908
Email
li20140821@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lirong Huo, Doctor
Organizational Affiliation
Office of academic research, Fu Xing Hospital, Capital Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Fu Xing Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Li, Doctor
Phone
+86-010-88062907
Email
liran817@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28196011
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.
Results Reference
background
PubMed Identifier
27079199
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.
Results Reference
background
PubMed Identifier
32132910
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.
Results Reference
background
PubMed Identifier
31093270
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.
Results Reference
background

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

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