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Investigating the Causal Role of preSMA in Levodopa-induced Dyskinesia in Parkinson's Disease

Targeting the Pre-supplementary Motor Area With Repetitive Transcranial Magnetic Stimulation to Alleviate Levodopa-induced Dyskinesia in Parkinson´s Disease

Using a within-subject cross-over design, we will include 20 patients with Parkinson disease (PD) and peak-of-dose dyskinesia.

Patients will be studied after withdrawal from their normal dopaminergic medication.

On two separate days, each patient will receive off-line, effective (high-intensity) or ineffective (low-intensity) 1 Hz repetitive transcranial magnetic stimulation (rTMS) of the presupplementary motor area (preSMA) before functional magnetic resonance (fMRI). Immediately after the patient will perform a Go/No-Go task during fMRI in the the OFF state for 9 minutes. Then the scan is paused and the patient will receive 200 mg fast-acting oral levodopa and undergo whole-brain task-related fMRI at 3 Tesla until peak-of-dose dyskinesia will emerge.

During task-related fMRI, patients has to click on a mouse with their right hand (Right-Go), left hand (Left-Go), or no action (No-Go) in response to arbitrary visual cues.

The patients will also be tested for different aspects of impulsivity using neuropsychological questionnaires and computerized tests.

Studieoversigt

Detaljeret beskrivelse

The most common form of levodopa-induced dyskinesias (LID) manifests when levodopa levels are highest and is referred to as peak-of-dose dyskinesia. 50% of patients experience LID after 4-6 years of treatment, reaching a frequency of 40% after 4-6 years. The main risk factors for developing LID are disease duration, levodopa dose and age-at-onset, but none of these factors alone can predict whether and when an individual patient with PD will develop LID. There is converging evidence that exogenously administered levodopa induces non-physiological release and reuptake of dopamine in the striatum. This non-physiological dopaminergic stimulation gives rise to aberrant plasticity in the striatum that causes a sensitization of the cortico-basal ganglia system to levodopa. Dyskinesia often severely affects patients' quality of life requiring advanced treatment.

Adopting a novel pharmacological fMRI (ph-fMRI) approach, our group recently identified a functional signature of LID in the human brain: To bypass any problems due to movement artefacts, fMRI was performed in the time-span between the administration of levodopa and the onset of dyskinesia. Ph-fMRI revealed that a single oral dose of levodopa caused an abnormal cortico-striatal activation and connectivity pattern in pre-SMA and putamen in LID patients relative to PD patients without LID. We predict that 1 Hz rTMS of pre-SMA will attenuate the levo-dopa-induced overactivity in the pre-SMA and putamen and normalise the pre-SMA-putamen connectivity pattern. This may possibly involve an altered interaction with the right inferior frontal gyrus (rIFG).On two separate days, each patient will receive effective (high-intensity) or ineffective (low-intensity) 1 Hz rTMS (i.e. control rTMS session) of the pre-SMA before fMRI (Off-line rTMS).

Pharmacological fMRI (ph-fMRI): Immediately after rTMS the patient will perform a Go/No-Go task during fMRI in the the OFF state for 9 minutes. Then the scan is paused and the patient will receive 200 mg fast-acting oral levodopa and undergo whole-brain task-related fMRI at 3 Tesla until peak-of-dose dyskinesia will emerge. During task-related fMRI, patients press a computer mouse with the right hand (Right-Go), left hand (Left-Go), or no action (No-Go) in response to arbitrary visual cues.

We want to include 20 patients in the final analysis of the study. In a previous comparable study we experienced a drop-out rate around a third. We therefore aim to enrol 30 patients.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Capital Region
      • Hvidovre, Capital Region, Danmark, 2650
        • Danish Research Centre for Magnetic Resonance

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's Disease (Hoehn & Yahr 1-3)
  • Peak-of-dose levodopa-induced dyskinesia

Exclusion Criteria:

  • Insufficient Danish language skills
  • Neurological disease other than Parkinson's Disease
  • Major psychiatric illness
  • Sedatives or serotonergic medication in their current treatment.
  • Severe tremor
  • Montreal Cognitive Assessment score < 26

Contraindication for transcranial magnetic stimulation:

  • Epilepsy or epilepsy in 1st degree relatives
  • Contraindications for MRI-scanning:
  • Pacemaker
  • Pregnancy
  • Metallic foreign objects inside the body
  • Severe claustrophobia

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: REAL TMS
30 minutes of repetitive transcranial magnetic stimulation with 100% of the patients' individual resting motor threshold.

Frequency: 1 Hz., Pulse shape: biphasic, Duration: 30 minutes (1800 pulses).

Neuronavigation: MRI-guided and robot-assisted neuronavigation using Localite software and an Axilum robot.

Sham-komparator: SHAM TMS
30 minutes of repetitive transcranial magnetic stimulation with 30% of the patients' individual resting motor threshold.

Frequency: 1 Hz., Pulse shape: biphasic, Duration: 30 minutes (1800 pulses).

Neuronavigation: MRI-guided and robot-assisted neuronavigation using Localite software and an Axilum robot.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Levodopa-induced change in task-related regional neural activity as indexed by the blood oxygen level dependent (BOLD) signal
Tidsramme: Within the first 60 minutes after levodopa intake
A single priming session of REAL rTMS over the preSMA will attenuate the abnormal pharmacodynamic BOLD response (which is an index of regional neural activity) in the cortico-basal ganglia loop after levodopa challenge compared with SHAM rTMS.
Within the first 60 minutes after levodopa intake

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Onset of LID
Tidsramme: Within the first 60 minutes after levodopa intake
A single priming session of REAL rTMS over the SMA will prolong the time to onset of LID compared with SHAM.
Within the first 60 minutes after levodopa intake
Severity of LID
Tidsramme: Within the first 60 minutes after levodopa intake
A single priming session of REAL rTMS over the SMA will lower the the severity of LID measured on the Unified Dyskinesia Rating Scale (UDysRS) compared with SHAM.
Within the first 60 minutes after levodopa intake

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Hartwig R Siebner, MD, DMSci, Danish Research Centre for Magnetic Resonance

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. august 2017

Primær færdiggørelse (Faktiske)

16. september 2018

Studieafslutning (Faktiske)

16. september 2018

Datoer for studieregistrering

Først indsendt

1. juni 2017

Først indsendt, der opfyldte QC-kriterier

24. november 2017

Først opslået (Faktiske)

28. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2019

Sidst verificeret

1. august 2018

Mere information

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Kliniske forsøg med Parkinsons sygdom

Kliniske forsøg med Repetitive transcranial magnetic stimulation

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