rTMS-behandling ved vaskulær Parkinsonisme (rTMS)
Effekt af gentagen transkraniel magnetisk stimulering i vaskulær parkinsonisme
Vascular parkinsonism (VP), parkinsonism resulting from ischemic cerebrovascular disease, was suggested in 1929. The main features are wide-based gait, postural instability, and falls, which make patients with VP frustrated. Currently, the treatment is challenging.
Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain, and repetitive transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to explore the therapeutic effect of rTMS for the VP.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
-
Primary outcome
- The number of steps
-
Secondary outcome
- UPDRS part III - motor part
- Finger tapping test with right hand
- The completion time during the SWS test
- Freezing episodes of gait trajectory (two tasks)
- Clinical Global Impression Scale
- Patient's Global Impression Scale
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Busan, Sydkorea
- Inje university, Busan Paik Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Vascular parkinsonism
- age 18 and older
Exclusion Criteria:
- pregnant or any, other medical, surgical, neurological or psychiatric conditions
- other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
- any past or current history of seizure disorder or epilepsy
- unable to give informed consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Real rTMS Supplementary motor area
Real rTMS will be applied over the supplementary motor area |
There will be a series of four rTMS blocks separated by 10 minutes. Each block will consist of 15 to 25 pulse trains of 1-second duration at 25 Hz, with an intertrain interval of 10 seconds.
Andre navne:
|
|
Sham-komparator: Sham rTMS Supplementary motor area
Sham rTMS will be applied over the supplementary motor area |
There will be no real brain stimulation in Sham rTMS, and participant will be blinded.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS)
Tidsramme: 2 days
|
Motor functions will be checked using UPDRS. Each item of the motor part ranges from 0 to 4 (0 means normal, 4 means worst condition). Total sum will be calculated. |
2 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Finger tapping test with right hand
Tidsramme: 2 days
|
Finger tapping test with right hand, as quickly as possible for 15 second. The total number of taps will be calculated. The test will be twice with one minute interval. After the test performed twice, the average of the tests will be used. |
2 days
|
|
The total number of steps during the stand-walk-sit (SWS) test
Tidsramme: 2 days
|
SWS test is Standing up, making a 9 m round trip, and sitting down as quickly as possible. The number of steps will be recorded. |
2 days
|
|
The completion time during the SWS test
Tidsramme: 2 days
|
The completion time will be recorded. |
2 days
|
|
Freezing episodes of gait trajectory
Tidsramme: 2 days
|
The number of freezing episodes during rapid full turns and dual task |
2 days
|
|
Patient and Clinical Global Impression Scale
Tidsramme: 2 days
|
7-point scale that requires the patient (or clinician) to rate the response of the interventions. The rating will be numbered (1: very much improved; 2: much improved; 3: minimally improved; 4: no changes; 5: minimally worse; 6: much worse; 7: very much worse). |
2 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sang Jin Kim, MD, PhD, Inje Unversity, Busan Paik Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 18-0089
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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