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Theta-Burst-Stimulation in Recurrent Stroke Recovery

25. november 2019 oppdatert av: Christian Grefkes, University Hospital of Cologne
The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.

By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.

The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Tyskland
      • Cologne, Tyskland, 50937
        • Christian Grefkles

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

40 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • written consent
  • age: 40-90 years
  • recurrent stroke
  • hemiparesis with impaired hand motor function

Exclusion Criteria:

  • Subjects who are legally detained in an official institute (§20 MPG)
  • Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
  • Medication pump (e.g. insulin pump)
  • Metal splinters in eye or head
  • Pregnancy / breastfeeding
  • Severe Neurodegenerative disease
  • Severe Neuroinflammatory disease
  • History of seizures / epilepsy
  • Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
  • Insufficient compliance
  • Present or past malignant tumor involving the central nervous system
  • Severe Psychiatric disease
  • Frequent medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Real-iTBS
Enhet: Magstim Super Rapid2 System
Intermittent theta-burst-stimulation (iTBS) protocol
Enhet: Magstim Super Rapid2 System
Sham stimulation
Sham-komparator: Sham-iTBS
Enhet: Magstim Super Rapid2 System
Intermittent theta-burst-stimulation (iTBS) protocol
Enhet: Magstim Super Rapid2 System
Sham stimulation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relative grip force
Tidsramme: 3 months after enrollment
grip force as measured with vigorimeter
3 months after enrollment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Relative grip force
Tidsramme: After 8 days of intervention, and 3 months of enrollment
Grip force as measured with vigorimeter
After 8 days of intervention, and 3 months of enrollment
Motor function
Tidsramme: After 8 days of intervention, and 3 months of enrollment
Action Research Arm Test, ARAT
After 8 days of intervention, and 3 months of enrollment
Motor function
Tidsramme: After 8 days of intervention, and 3 months of enrollment

Fugl-Meyer Motor Scale of the upper extremity, FM The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully.

Minimum score in upper limb = 0 Maximum score in upper limb = 66, Subscales are summed
After 8 days of intervention, and 3 months of enrollment
Stroke severity
Tidsramme: After 8 days of intervention, and 3 months of enrollment

National Instituts of Health Stroke Scale, NIHSS The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.

The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
After 8 days of intervention, and 3 months of enrollment
Degree of disability
Tidsramme: After 8 days of intervention, and 3 months of enrollment
Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).
After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Motor evoked potential
Tidsramme: After 8 days of intervention, and 3 months of enrollment
Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Resting motor threshold
Tidsramme: After 8 days of intervention, and 3 months of enrollment
Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Short-interval intracortical inhibition
Tidsramme: After 8 days of intervention, and 3 months of enrollment
Short-interval intracortical inhibition Short-interval intracortical inhibition (SICI) is a widely used paired-pulse transcranial magnetic stimulation (TMS) measure to assess inhibition in human motor cortex
After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Ipsilateral silent period
Tidsramme: After 8 days of intervention, and 3 months of enrollment
Ipsilateral silent period The ipsilateral silent period (iSP) is supposed to be a specific marker of transcallosal motor inhibition. Measured by a short attenuation or interruption of ongoing voluntary electromyographic (EMG) activity in hand muscles induced by focal TMS of the ipsilateral M1.
After 8 days of intervention, and 3 months of enrollment
Quality of life
Tidsramme: After 8 days of intervention, and 3 months of enrollment
EuroQol 5D questionnaire, EQ-5D
After 8 days of intervention, and 3 months of enrollment
Activities of daily living at admission and discharge in external rehabilitation facility
Tidsramme: After 8 days of intervention, and 3 months of enrollment
Barthel-Index (BI) scores as documented by external rehabilitation facility The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The scale yield a score of 0-100.
After 8 days of intervention, and 3 months of enrollment
Days of rehabilitation after intervention phase
Tidsramme: 3 months after enrollment
Days of rehabilitation after intervention phase as documented by external rehabilitation facility
3 months after enrollment

Samarbeidspartnere og etterforskere

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

Sponsor

University Hospital of Cologne

Etterforskere

  • Hovedetterforsker: Christian Grefkes, MD, University Hospital Cologne

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)

11. januar 2018

Primær fullføring (Forventet)

1. november 2021

Studiet fullført (Forventet)

1. november 2021

Datoer for studieregistrering

Først innsendt

3. november 2017

Først innsendt som oppfylte QC-kriteriene

6. november 2017

Først lagt ut (Faktiske)

9. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • U1111-1204-6783

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Nei

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