- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03354455
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Capital Region
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Hvidovre, Capital Region, Danimarca, 2650
- Danish Research Centre for Magnetic Resonance
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: REAL TMS
30 minutes of repetitive transcranial magnetic stimulation with 100% of the patients' individual resting motor threshold.
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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. |
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Comparatore fittizio: SHAM TMS
30 minutes of repetitive transcranial magnetic stimulation with 30% of the patients' individual resting motor threshold.
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Levodopa-induced change in task-related regional neural activity as indexed by the blood oxygen level dependent (BOLD) signal
Lasso di tempo: Within the first 60 minutes after levodopa intake
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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.
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Within the first 60 minutes after levodopa intake
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Onset of LID
Lasso di tempo: Within the first 60 minutes after levodopa intake
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A single priming session of REAL rTMS over the SMA will prolong the time to onset of LID compared with SHAM.
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Within the first 60 minutes after levodopa intake
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Severity of LID
Lasso di tempo: Within the first 60 minutes after levodopa intake
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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.
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Within the first 60 minutes after levodopa intake
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Hartwig R Siebner, MD, DMSci, Danish Research Centre for Magnetic Resonance
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Inizio studio (Effettivo)
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Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disturbi indotti chimicamente
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Manifestazioni neurologiche
- Malattie parkinsoniane
- Malattie dei gangli basali
- Disturbi del movimento
- Sinucleinopatie
- Malattie Neurodegenerative
- Effetti collaterali correlati al farmaco e reazioni avverse
- Avvelenamento
- Sindromi da neurotossicità
- Morbo di Parkinson
- Discinesia
- Discinesia, indotta da farmaci
Altri numeri di identificazione dello studio
- H-15017863
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