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

2. august 2022 oppdatert av: Ran Li, Fu Xing Hospital, Capital Medical University

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100000
        • Rekruttering
        • Fu Xing Hospital, Capital Medical University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control group
Stroke patients accept the traditional rehabilitation alone.
Aktiv komparator: Transcranial Direct Current Stimulation group
Stroke patients accept the Transcranial Direct Current Stimulation alone.
Atferdsmessig: 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.
Aktiv komparator: Motor imagery group
Stroke patients do the motor imagery alone.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb
Tidsramme: Baseline
Complete the scale at baseline
Baseline
Behavioral assessment by Fugl-Meyer Assessment for Upper Limb change
Tidsramme: 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.
Immediately after intervention
Behavioral assessment by Action Research Arm Test
Tidsramme: Baseline
Complete the above scale at baseline
Baseline
Behavioral assessment by Action Research Arm Test change
Tidsramme: 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.
Immediately after intervention
Motor network construction
Tidsramme: 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.
Baseline
Motor network change
Tidsramme: 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.
Immediately after intervention
Cerebral perfusion calculation
Tidsramme: 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.
Baseline
Cerebral perfusion change
Tidsramme: Immediately after intervention
Change from baseline cerebral perfusion immediately after intervention is obtained by subtracting the baseline from the later Cerebral Blood Flow value.
Immediately after intervention

Samarbeidspartnere og etterforskere

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Sponsor

Fu Xing Hospital, Capital Medical University

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. juni 2021

Primær fullføring (Forventet)

1. desember 2023

Studiet fullført (Forventet)

1. juni 2024

Datoer for studieregistrering

Først innsendt

12. juni 2021

Først innsendt som oppfylte QC-kriteriene

21. juni 2021

Først lagt ut (Faktiske)

29. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. august 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2022

Sist bekreftet

1. august 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2021FXHEC-KSKY002

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