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

NCT ID: NCT04944680

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Upper Extremity Dysfunction Transcranial Direct Current Stimulation Image, Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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.

Study Groups

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Control group

Stroke patients accept the traditional rehabilitation alone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Transcranial Direct Current Stimulation group

Stroke patients accept the Transcranial Direct Current Stimulation alone.

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation therapy

Intervention Type BEHAVIORAL

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 group

Stroke patients do the motor imagery alone.

Group Type ACTIVE_COMPARATOR

Motor imagery therapy

Intervention Type BEHAVIORAL

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 group

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

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation and motor imagery therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Xing Hospital, Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ran Li

Doctor Li

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lirong Huo, Doctor

Role: STUDY_DIRECTOR

Office of academic research, Fu Xing Hospital, Capital Medical University

Locations

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Fu Xing Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ran Li, Doctor

Role: CONTACT

+86-010-88062907

Yong Wang, Doctor

Role: CONTACT

+86-010-88062908

Facility Contacts

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Ran Li, Doctor

Role: primary

+86-010-88062907

References

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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.

Reference Type BACKGROUND
PMID: 28196011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27079199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32132910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31093270 (View on PubMed)

Other Identifiers

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2021FXHEC-KSKY002

Identifier Type: -

Identifier Source: org_study_id

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