A Closed-loop Brain-computer Interface for Stroke
7. juli 2020 oppdatert av: Taipei Veterans General Hospital, Taiwan
A Closed-loop Brain-computer Interface for Paretic Hand Stimulation After Stroke
It may be hard to acquire stable sensorimotor rhythm from the affected motor cortex for patient without a response of paretic hand.
A few studies suggest two ways to approaching closed-loop therapy: peripherally extracting the residual signals, for example electromyogram (EMG) at proximal muscles (deltoids) and centrally extracting the activity patterns from unaffected hemisphere during attempting to move paretic hand.
Therefore, understanding neural signatures of residual upper extremity movement among stroke patients might help in discovering potential therapeutic target and developing tailored brain-computer interface (BCI) therapy.
Additionally, 59.4% of stroke patients in acute stage impair at least one somatosensory modality.
It remains unclear whether the patient with somatosensory impairment hinder BCI effect.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
Investigators will consecutively enroll subacute (1-4 weeks after stroke onset) patients with first-time, unilateral, subcortical stroke and age-matched healthy controls.
All participants will carry on 2 sequential experiments.
In the first experiment, participants will perform 2 motor tasks using either paretic/nondominant upper extremity or non-paretic/dominant upper extremity, called motor attempt (M) condition or calibration condition.
The second experiment contains 3 conditions: cyclic functional electrical stimulation (cFES), cFES during motor attempt (M-cFES), and functional electrical stimulation during brain-computer interface (BCI-FES) in random order.
The sensorimotor oscillations from the electroencephalography (EEG), upper extremity sensorimotor function score (Fugl-Meyer test, Action Research Arm test, and Revised Nottingham Sensation Assessment), corticospinal excitability from the transcranial magnetic stimulation (TMS), and resting-state functional and structural neuroimage from magnetic resonance imaging (MRI) will be assessed before and after the final experiment, as well as 3 months after stroke.
Studietype
Observasjonsmessig
Registrering (Forventet)
70
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Taipei city, Taiwan, 112
- Rekruttering
- Taipei Veterans General Hospital
-
Ta kontakt med:
- i-hui Lee, MD, PhD
- Telefonnummer: 8109 886-2-28712121
- E-post: ihui_lee@hotmail.com
-
Hovedetterforsker:
- i-hui Lee, MD, PhD
-
-
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
20 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Hospitalized participants and healthy controls will be recruited from the Taipei Veterans General Hospital.
Beskrivelse
Inclusion Criteria:
- first-ever, unilateral infarction or hemorrhage at middle cerebral artery or posterior cerebral artery territory
- early subacute phase of stroke (between 1 and 4 weeks after stroke onset)
Exclusion Criteria:
- electroencephagraphy feature is not usable
- Fugl-Meyer Assessment of Upper Extremity score is over 50
- ataxia
- global aphasia
- concomitant neurological diseases
- psychiatric diseases
- participating in other interventional research during this period
- other conditions might interfere with experiment
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensorimotor rhythms
Tidsramme: Baseline, during experimental procedures
|
electroencephalography
|
Baseline, during experimental procedures
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fugl-Meyer Assessment
Tidsramme: At baseline (1-4 week of stroke) and at 3 months after stroke
|
Fugl-Meyer Assessment (FMA) measures both upper-limb and lower-limb motor function.
The total score of FMA ranges from 0 to 100, which higher score indicates better motor recovery.
|
At baseline (1-4 week of stroke) and at 3 months after stroke
|
|
Action Research Arm test
Tidsramme: At baseline (1-4 week of stroke) and at 3 months after stroke
|
Action Research Arm test (ARAT) measures specific upper-limb and hand function.
The total score of ARAT ranges from 0 to 57, which higher score indicates better motor function.
|
At baseline (1-4 week of stroke) and at 3 months after stroke
|
|
Revised Nottingham Sensation Assessment
Tidsramme: At baseline (1-4 week of stroke) and at 3 months after stroke
|
Revised Nottingham Sensation Assessment (rNSA) measures various upper-limb sensory function.
The total score of rNSA ranges from 0 to 151, which higher score indicates better somatosensory function.
|
At baseline (1-4 week of stroke) and at 3 months after stroke
|
|
Motor Activity Log
Tidsramme: At baseline (1-4 week of stroke) and at 3 months after stroke
|
Motor Activity Log (MAL) measures real-use of upper-limb.
The averaged index of MAL ranges from 0 to 5, which higher index indicates more frequently use of paretic upper limb.
|
At baseline (1-4 week of stroke) and at 3 months after stroke
|
|
Resting motor threshold
Tidsramme: At baseline (1-4 week of stroke) and at 3 months after stroke
|
Transcranial magnetic stimulation test
|
At baseline (1-4 week of stroke) and at 3 months after stroke
|
|
Motor evoked potential
Tidsramme: At baseline (1-4 week of stroke) and at 3 months after stroke
|
Transcranial magnetic stimulation test
|
At baseline (1-4 week of stroke) and at 3 months after stroke
|
|
Resting-state brain connectivity
Tidsramme: At baseline (1-4 week of stroke) and at 3 months after stroke
|
Magnetic resonance imaging
|
At baseline (1-4 week of stroke) and at 3 months after stroke
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Forventet)
13. juli 2020
Primær fullføring (Forventet)
31. august 2022
Studiet fullført (Forventet)
31. august 2022
Datoer for studieregistrering
Først innsendt
20. april 2020
Først innsendt som oppfylte QC-kriteriene
7. juli 2020
Først lagt ut (Faktiske)
10. juli 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juli 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juli 2020
Sist bekreftet
1. juli 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019-08-017B
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .