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The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke

24. september 2020 oppdatert av: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

The Effect Of Sham Controlled Continuous Theta Burst Stimulation And Low Frequency Repetitive Transcranial Magnetic Stimulation On Upper Extremity Spasticity And Functional Recovery In Patients With Ischemic Stroke

This study is aimed to investigate the effect of continuous theta burst stimulation (cTBS) and low frequency repetitive transcranial magnetic stimulation (rTMS) on upper extremity spasticity and functional recovery in patients with chronic ischemic stroke.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

A sham-controlled double-blind randomized study was undertaken. 20 patients with chronic stroke were randomized into active rTMS group (n=7), active cTBS group (n=7) and sham cTBS group (n=6). In the active rTMS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In the active cTBS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. Sham cTBS was applied in the same protocol but using sham coil. Within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities under the guidance of a physiotherapist, regardless of which group they were in. Upper Extremity Fugl-Meyer Motor Function Scale, Modified Ashworth Scale (MAS), Functional Independence Measure (FIM), Motor Activity Log-28 (MAL-28) and Brunnstrom upper extremity and hand motor recovery stage were assessed at pre-treatment, post-treatment and follow up at 4 weeks.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia
    • Çankaya
      • Ankara, Çankaya, Tyrkia, 06100
        • Gaziler PMR, Training and Research Hospital, Department of PMR

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:

  • ischemic stroke with a disease interval of 6 months to 2 years
  • aged between 18-80 years
  • Mini mental test score ≥ 24
  • upper limb Brunnstrom recovery stage 3 to 5
  • upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS) 1+ to 3

Exclusion Criteria:

  • hemorrhagic stroke
  • history of epilepsy
  • a cardiac pacemaker
  • pregnancy
  • history of previous stroke or ischemic attack
  • neurological diseases other than stroke
  • metallic implant in brain or scalp (including cochlear implant)
  • previous brain surgery
  • orthopedic disease that prevents upper extremity movements
  • poor general health (due to heart failure, chronic obstructive pulmonary disease, severe infection, etc.)
  • diagnosis of malignancy
  • injections of botulinum toxin in the last 6 months for the affected upper extremity
  • drug or dosage changes of anti-spasticity medications in the last 1 month period

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: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Active rTMS group
chronic ischemic stroke patients receiving active low frequency repetitive transcranial magnetic stimulation therapy and physical therapy
Enhet: Active Repetitive Transcranial Magnetic Stimulation Therapy
10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.
Andre navn:
  • Rehabilitation Program
Aktiv komparator: Active cTBS group
chronic ischemic stroke patients receiving active continuous theta burst stimulation therapy and physical therapy
Enhet: Active Continuous Theta Burst Stimulation Therapy
10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.
Andre navn:
  • Rehabilitation Program
Sham-komparator: Sham cTBS group
chronic ischemic stroke patients receiving sham continuous theta burst stimulation therapy and physical therapy
Enhet: Sham Continuous Theta Burst Stimulation Therapy
10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and sham cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.
Andre navn:
  • Rehabilitation Program

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Upper Extremity Fugl-Meyer Motor Function Scale
Tidsramme: up to 6 weeks
Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.
up to 6 weeks
Modified Ashworth Scale
Tidsramme: up to 6 weeks
Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome.
up to 6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functional Independence Measure
Tidsramme: up to 6 weeks
Scale measures level of independence on activities of daily life (min-max: 18-126 points). Self-care part of the motor subscale was used in this study (min-max:6-42 points). Higher values represent a better outcome.
up to 6 weeks
Motor Activity Log-28
Tidsramme: up to 6 weeks
Scale measures frequency of use and functionality level of the affected upper limb during daily activities (min-max: 0-5 points). Higher values represent a better outcome.
up to 6 weeks
Brunnstrom Motor Recovery Scale
Tidsramme: up to 6 weeks
Scale measures upper extremity and hand motor recovery stages (min-max: 1-6). Higher values represent a better outcome.
up to 6 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Etterforskere

  • Studieleder: Bilge Yılmaz, Professor,MD, Gaziler PMR, Training and Research Hospital, Department of PMR
  • Hovedetterforsker: Ömer Kuzu, MD, Gaziler PMR, Training and Research Hospital, Department of PMR

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)

1. oktober 2018

Primær fullføring (Faktiske)

1. mai 2019

Studiet fullført (Faktiske)

1. mai 2019

Datoer for studieregistrering

Først innsendt

19. september 2020

Først innsendt som oppfylte QC-kriteriene

19. september 2020

Først lagt ut (Faktiske)

24. september 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2020

Sist bekreftet

1. september 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 5

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

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