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Effektivitet af transkranial magnetisk stimuleringsbehandling hos patienter, der er diagnosticeret med postpoliosyndrom: En randomiseret kontrolleret dobbeltblind undersøgelse

8. september 2026 opdateret af: Arzu On, Ege University
Undersøgelsen er planlagt til at omfatte mindst 26 patienter med lammet poliomyelitis, der opfylder PPS -diagnostiske kriterier (1). Patienter vil blive randomiseret i to grupper, og en gruppe vil kun modtage den træningsterapi, der bruges i standardbehandling, mens den anden gruppe vil modtage transkranial magnetisk stimulering (TMS) terapi ud over træning. TMS vil blive anvendt til studiegruppen 5 gange om ugen i 2 uger i alt 10 sessioner. Den protokol, der skal anvendes under undersøgelsen, indstilles til 1 Hz, og hver session varer 15 minutter. Alle deltagere vil blive evalueret med muskelstyrke (manuel muskeltest), 6-minutters vandringstest, polio-relaterede problemer Inventory, VAS-smerte, vas træthed, træthedsgradskala, Beck Depression Inventory, Nottingham Health Profile Scales før, i slutningen af ​​behandlingen og i slutningen af ​​den 3. måned. Som et resultat af evalueringen måles de potentielle positive effekter af TM'er på patienter med PPS, og evidensbaserede data til brug af denne behandlingsmodalitet hos patienter med PPS opnås. Denne undersøgelse vil være den første til at evaluere effektiviteten af ​​TMS på en kontrolleret måde i en patientgruppe med PPS. Som et resultat af evalueringen måles de potentielle positive effekter af TM'er på patienter med PPS, og evidensbaserede data opnås til anvendelse af denne behandlingsmodalitet hos patienter med PPS.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • BORNOVA
      • Izmir, BORNOVA, Tyrkiet (Türkiye), 35100
        • Ege University Faculty of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inkluderingskriterier: -Varge blevet diagnosticeret med PPS (postpoliosyndrom) -Havning ikke modtaget TMS -behandling før

-

Ekskluderingskriterier: -historie om epilepsi

  • Tilstedeværelse af en anden sygdom, der kan være forbundet med symptomerne
  • Manglende evne til at ambulere uafhængigt
  • Tilstedeværelse af et neurologisk, psykiatrisk eller visionrelateret problem, der kan forhindre patienten i at besvare spørgeskemaerne
  • Tilstedeværelse af ferromagnetisk materiale implanteret i kroppen
  • Organisk hjernepatologi (vaskulær, traumatisk, tumoral osv.)
  • Historie om brug af medikamenter, der sænker anfaldstærsklen (hvis ikke modtager antiepileptisk behandling)
  • Alvorlig eller nylig hjertesygdom
  • Alkoholisme
  • Graviditet

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: Sham rTMS
Sham stimulation followed the same treatment schedule as active rTMS, with the coil reversed and the device operated at minimum output, providing auditory input without effective cortical stimulation. Ten sessions were administered over 2 weeks. All participants received an individualized home exercise program based on limb involvement and muscle strength. Resistive exercise was limited to muscle groups graded at least 3/5 on manual muscle testing and was prescribed according to energy-conservation principles.
Medicin: Sham rTMS
Sham stimulation followed the same schedule as active rTMS, with the coil reversed and the device operated at minimum output, providing auditory input without effective cortical stimulation. Ten sessions were administered over 2 weeks.
Adfærdsmæssigt: Individualized home exercise program
An individualized home exercise program was prescribed based on limb involvement and muscle strength. Resistive exercise was limited to muscle groups graded at least 3/5 on manual muscle testing and was prescribed according to energy-conservation principles.
Eksperimentel: Active rTMS
Active rTMS was delivered using a Magstim Rapid2 stimulator and a figure-of-eight D70 coil (Magstim Company Ltd, Whitland, United Kingdom). The target was the lower-extremity representation of the primary motor cortex near the vertex. Stimulation was delivered at 80% of resting motor threshold, at 1 Hz for 20 minutes (1200 pulses per session), over 10 sessions in 2 weeks. All participants received an individualized home exercise program based on limb involvement and muscle strength. Resistive exercise was limited to muscle groups graded at least 3/5 on manual muscle testing and was prescribed according to energy-conservation principles.
Adfærdsmæssigt: Individualized home exercise program
An individualized home exercise program was prescribed based on limb involvement and muscle strength. Resistive exercise was limited to muscle groups graded at least 3/5 on manual muscle testing and was prescribed according to energy-conservation principles.
Enhed: Repetitive transcranial magnetic stimulation (rTMS)
Active rTMS was delivered using a Magstim Rapid2 stimulator and a figure-of-eight D70 coil. Stimulation was applied over the lower-extremity representation of the primary motor cortex near the vertex at 1 Hz and 80% of the resting motor threshold for 20 minutes (1200 pulses per session), for 10 sessions over 2 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6 minute walk test (6MWT)
Tidsramme: Baseline, immediately after treatment, and 3-month follow-up
It is a test used to assess the level of functional exercise or functional capacity. The patient is asked to walk, but not run, in a 25 m long corridor at the highest possible speed without stopping. At the end of 6 minutes, the number of metres walked by the patient is recorded. The 6 min walk test is an evaluation criterion used in routine and clinical research to assess functional capacity in many diseases such as heart failure, general arthrosis, multiple sclerosis.
Baseline, immediately after treatment, and 3-month follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Polio-Related Problems Scale (PRPS)
Tidsramme: Baseline, immediately after treatment, and 3-month follow-up
The Polio-Related Problems Scale (PRPS) assesses the severity of post-polio-related symptoms and functional problems. Higher scores indicate greater symptom burden and impairment.
Baseline, immediately after treatment, and 3-month follow-up
Nottingham health profile (NHP)
Tidsramme: Baseline, immediately after treatment, and 3-month follow-up
It consists of 38 items assessing how severe an impact the respondent thinks their health is having on six dimensions: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. Every item has a different weight, depending on the severity of the symptom. The sum of the weighted scores is 100 for each subdimension. Thus, summing all weighted values of every item, the score between 0 and 100 is obtained for each subdimension. The total score was obtained by summing the scores of six subdimensions, giving the values between 0 and 600. Higher scores indicate a greater level of distress
Baseline, immediately after treatment, and 3-month follow-up
Visual analogue scale (VAS) for pain and fatigue
Tidsramme: Baseline, immediately after treatment, and 3-month follow-up

Severity of pain that the participants have had in the past week was evaluated by using visual analogue scale (VAS) on a 10-cm horizontal line where 0-cm represented "no pain" and 10 cm the "worst imaginable pain"

Severity of fatigue experienced by the participants in the past week was assessed by using VAS on a 10-cm horizontal line where 0-cm represented "not tired at all" and 10-cm "extremely tired"
Baseline, immediately after treatment, and 3-month follow-up
Manual muscle testing (MMT)
Tidsramme: Baseline, immediately after treatment, and 3-month follow-up
Muscle strength of the hip flexors, knee extensors, knee flexors, ankle dorsiflexors, and plantar flexors were measured bilaterally according to the Medical Research Council Scale . A sum score (manual muscle testing [MMT] sum) was obtained by adding the scores of all muscle groups tested (max score: 50)
Baseline, immediately after treatment, and 3-month follow-up
Fatigue Impact Scale (FIS)
Tidsramme: Baseline, immediately after treatment, and 3-month follow-up
Cognitive, functional and fatigue subscales are available and high scores are associated with poor fatigue level. The scale is scored from 0 to 120 points.
Baseline, immediately after treatment, and 3-month follow-up
Beck Depression Inventory (BDI)
Tidsramme: Baseline, immediately after treatment, and 3-month follow-up
The Beck depression test is used to measure how intensely depressed a person is during a 1-week period.21 questions; each question is scored between 0 and 3. The degree of depression is determined according to the total score (0-9: minimal depression, 10-16: mild depression, 17-29: moderate depression, 30-63: severe depression).
Baseline, immediately after treatment, and 3-month follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ege University

Efterforskere

  • Ledende efterforsker: Arzu On, Prof.Dr, Ege Universtiy

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2024

Primær færdiggørelse (Faktiske)

20. juni 2025

Studieafslutning (Faktiske)

25. juli 2025

Datoer for studieregistrering

Først indsendt

7. april 2025

Først indsendt, der opfyldte QC-kriterier

7. april 2025

Først opslået (Faktiske)

13. april 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1174637

Plan for individuelle deltagerdata (IPD)

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