Temporal Interferensstimulering på motorske symptomer ved Parkinsons sykdom
28. mai 2026 oppdatert av: Yu Liu, Shanghai University of Sport
Effekter og mekanismer av ikke-invasiv dyp hjernestimulering hos pasienter med Parkinsons sykdom
Målet med denne kliniske studien er å undersøke om en type hjernestimulering kalt transkraniell temporal interferensstimulering (TIS) av den indre globus pallidus (GPi) kan bidra til å forbedre bevegelsessymptomer hos personer med Parkinsons sykdom. Studien vil også undersøke hvordan TIS endrer hjerneaktivitet i forbindelse med disse forbedringene.
Hovedspørsmålene denne studien tar sikte på å besvare er:
- Hvor mye kan gjentatte TIS-økter forbedre bevegelsessymptomer hos personer med Parkinsons sykdom?
- Kan disse forbedringene vare i opptil to måneder etter at behandlingen avsluttes?
- Hvilke endringer i hjerneaktivitet skjer sammen med forbedringene?
Forskere vil sammenligne personer som mottar aktiv TIS med de som mottar simulert (placebolignende) stimulering for å se om aktiv TIS fører til bedre bevegelsesutfall.
Deltakere vil:
- Motta 10 økter med aktiv eller simulert TIS over to uker
- Fullføre bevegelsesvurderinger under den to ukers behandlingsperioden og igjen 2, 4 og 8 uker etterpå
- Fullføre hjerneaktivitetvurderinger før og etter den to ukers behandlingsperioden
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
37
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200438
- Shanghai University of Sport
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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
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Idiopatisk Parkinsons sykdom (PD) diagnostisert av lege i henhold til Movement Disorder Society (MDS) diagnostiske kriterier, med debut etter 40 års alder.
- Stabil medikasjonsregime for Parkinsons sykdom, inkludert levodopa-basert behandling, uendret i minst 4 uker før og under studien.
- Hoehn og Yahr (H&Y) stadier 1.5 til 3 og evne til å gå uten hjelp.
- Fravær av demens, definert som en Montreal Cognitive Assessment (MoCA) score ≥ 21.
Eksklusjonskriterier:
- Eventuelle kontraindikasjoner for MR eller temporal interferensstimulering gjennom hodeskallen (TIS), inkludert klaustrofobi, metallimplantater i hodet eller hjertet, eller historie med elektrokonvulsiv terapi.
- Nåværende bruk av antipsykotiske, antidepressiva eller andre dopaminmodulerende medikamenter.
- Tilstedeværelse av ortopediske tilstander som kan forstyrre motoriske vurderinger, som artrose eller nylig ortopedisk kirurgi (innenfor de siste 6 månedene).
- Historie med legediagnostisert alvorlig psykisk sykdom.
- Legediagnostiserte kardiovaskulære risikoer som kan kontraindicere trening eller studiedeltakelse.
- Tidligere historie med dyp hjerne stimulering (DBS) kirurgi.
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: TIS Group
Deltakerne i denne gruppen vil motta aktiv transkraniell temporal interferensstimulering rettet mot den indre globus pallidus over en to-ukers intervensjonsperiode.
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Transkraniell temporal interferensstimulering (TIS) er en ikke-invasiv hjerne stimuleringsteknikk som leverer to høgfrekvente vekselstrømmer gjennom skalpelektroder for å generere et lavfrekvent interferensfelt i dype hjerneområder.
I denne studien retter TIS seg mot den indre globus pallidus (GPi) for å modulere nevral aktivitet hos personer med Parkinsons sykdom.
Deltakerne mottar 10 stimuleringsøkter over to uker.
Sham-TIS-tilstanden bruker samme oppsett, men bruker lavfrekvente strømmer uten å generere et interferensmønster.
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Sham-komparator: Sham Group
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention.
However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations.
The sham procedure consists of 10 sessions delivered over a two-week period, without therapeutic stimulation.
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Transkraniell temporal interferensstimulering (TIS) er en ikke-invasiv hjerne stimuleringsteknikk som leverer to høgfrekvente vekselstrømmer gjennom skalpelektroder for å generere et lavfrekvent interferensfelt i dype hjerneområder.
I denne studien retter TIS seg mot den indre globus pallidus (GPi) for å modulere nevral aktivitet hos personer med Parkinsons sykdom.
Deltakerne mottar 10 stimuleringsøkter over to uker.
Sham-TIS-tilstanden bruker samme oppsett, men bruker lavfrekvente strømmer uten å generere et interferensmønster.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III).
The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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A responder was defined as a participant with a reduction of at least 5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) total score.
Scores range from 0 to 132, with higher scores indicating more severe motor impairment; therefore, a reduction in score indicates improvement.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in non-motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) (Non-Motor Experiences of Daily Living).
The total score ranges from 0 to 52, with higher scores indicating more severe non-motor symptoms (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in motor symptoms affecting daily living assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) (Motor Experiences of Daily Living).
The total score ranges from 0 to 52, with higher scores indicating more severe motor difficulties in daily living (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Epworth Sleepiness Scale Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in daytime sleepiness assessed using the Epworth Sleepiness Scale .
The Epworth Sleepiness Scale is a self-administered questionnaire consisting of 8 items, with total scores ranging from 0 to 24, where higher scores indicate greater daytime sleepiness (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Sleep Scale-2 Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in sleep disturbances assessed using the Parkinson's Disease Sleep Scale-2. The Parkinson's Disease Sleep Scale-2 is a patient-reported questionnaire consisting of 15 items, with total scores ranging from 0 to 60, where higher scores indicate more severe sleep disturbances (worse outcome). |
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Gait Performance Measures
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Changes in gait performance will be assessed using an instrumented gait mat during single-task and dual-task walking conditions. Spatiotemporal gait parameters, including gait speed, step length, stride length, step width, cadence, and gait variability, will be collected during standardized walking trials. Improvements in gait performance are indicated by increased gait speed, longer step and stride length, and reduced gait variability under both single-task and dual-task conditions. |
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Balance Performance Measures
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Changes in balance performance will be assessed using a force platform during standardized standing balance tasks. Center of pressure (COP) parameters, including COP path length, sway area, and sway velocity, will be derived from force platform recordings to quantify postural stability. Improved balance performance is indicated by reduced COP displacement, smaller sway area, and lower sway velocity. |
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Magnetic Resonance Imaging (MRI) Measures
Tidsramme: Baseline and immediately after the intervention
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Changes in brain structure and/or function will be assessed using magnetic resonance imaging (MRI). MRI data will be acquired to evaluate intervention-related changes in brain regions associated with motor control. Imaging-derived measures may include structural and functional metrics obtained from standardized MRI protocols. |
Baseline and immediately after the intervention
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the bradykinesia subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III).
The total bradykinesia subscore ranges from 0 to 48, with higher scores indicating more severe bradykinesia.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the rigidity subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III).
The total rigidity subscore ranges from 0 to 20, with higher scores indicating more severe rigidity.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the axial signs subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III).
The total axial signs subscore ranges from 0 to 20, with higher scores indicating more severe axial motor impairment.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the tremor subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III).
The total tremor subscore ranges from 0 to 40, with higher scores indicating more severe tremor.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in the Home Diary Assessment of Motor States (Medication-ON Without Dyskinesia)
Tidsramme: Baseline, weekly averages during weeks 1 and 2 of the intervention
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The motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF. Baseline assessment will be defined as the average percentage of waking time spent in ON states over three consecutive days immediately prior to the intervention. The 1-week assessment will be defined as the average percentage of waking time spent in ON states over the five intervention days of the first intervention week, and the 2-week assessment as the average over the five intervention days of the second intervention week. The outcome measure is defined as the percentage of total recorded waking time spent in ON states, calculated from the home diary data. A higher percentage of time spent in ON states indicates milder motor symptoms and better motor control. |
Baseline, weekly averages during weeks 1 and 2 of the intervention
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Change From Baseline in the Home Diary Assessment of Motor States (Medication-OFF)
Tidsramme: Baseline, weekly averages during weeks 1 and 2 of the intervention
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The motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF. Baseline assessment will be defined as the average percentage of waking time spent in the Medication-OFF state over three consecutive days immediately prior to the intervention. Week 1 and Week 2 assessments will be calculated as the average percentage of waking time spent in the Medication-OFF state over the five intervention days of each intervention week. The outcome measure is defined as the percentage of total recorded waking time spent in the Medication-OFF state, calculated from the home diary data. A lower percentage of time spent in the Medication-OFF state indicates milder motor symptoms and better motor control. |
Baseline, weekly averages during weeks 1 and 2 of the intervention
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change in quality of life assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39).
The PDQ-39 consists of 39 items across 8 domains, with total scores ranging from 0 to 100, where higher scores indicate poorer health-related quality of life (worse outcome).
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the mobility domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer mobility-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the activities of daily living domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of daily living-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the emotional well-being domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of emotional well-being-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the stigma domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of stigma-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the social support domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of social support-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the cognitions domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of cognitions-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the communication domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of communication-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score
Tidsramme: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Change from baseline in the bodily discomfort domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease.
Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of bodily discomfort-related quality of life.
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Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
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Studer hoveddatoer
Studiestart (Faktiske)
29. desember 2025
Primær fullføring (Faktiske)
15. april 2026
Studiet fullført (Faktiske)
15. april 2026
Datoer for studieregistrering
Først innsendt
15. november 2025
Først innsendt som oppfylte QC-kriteriene
28. desember 2025
Først lagt ut (Faktiske)
30. desember 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 102772024RT146
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