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

NCT03354455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-08-06

No results posted yet for this study

Summary

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.

Conditions

  • Dyskinesia, Drug-Induced
  • Parkinson Disease

Interventions

DEVICE

Repetitive transcranial magnetic stimulation

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.

Sponsors & Collaborators

  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER

  • Danish Movement Disorder Society (DANMODIS)

    collaborator UNKNOWN

  • Danish Parkinson Association

    collaborator OTHER

  • Danish Research Centre for Magnetic Resonance

    lead OTHER

Principal Investigators

  • Hartwig R Siebner, MD, DMSci · Danish Research Centre for Magnetic Resonance

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-09-16
Completion
2018-09-16

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354455 on ClinicalTrials.gov