rTMS as an Intervention for Levodopa-induced Dyskinesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDanish Research Centre for Magnetic Resonance
About this trial
The proposed study investigates the use of repetitive transcranial magnetic stimulation (rTMS) as a treatment for levodopa-induced dyskinesia (LID) in Parkinson's Disease (PD). Specifically, the study aims to determine whether patterned stimulation of the pre-supplementary motor area (pre-SMA) can delay the onset of LID after levodopa intake and reduce LID severity in PD patients. This study will provide critical insights into potential targets for rTMS treatment, optimal rTMS parameters, and the mechanisms underlying LID in Parkinson's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinically established or probable PD
Clinical Diagnostic Criteria for Parkinson's Disease
Peak-of-dose levodopa-induced dyskinesia.
Stable antiparkinsonian medicine for at least four weeks.
Disqualifiers
Psychiatric disorders.
Usage of antipsychotic medication, Donepezil, and GABAergic medications (such as pregabalin and gabapentin).
Regular usage of benzodiazepines and opioids (more than once per week).
History of neurological disease other than Parkinson's disease.
Trial design
Design model
Crossover
Treatments tested in this trial
active TMS
DeviceTranscranial magnetic stimulation using MagVenture XP Orange Stimulator using active side of MagVenture Cool-B70 coil
sham TMS
DeviceSham transcranial magnetic stimulation using MagVenture XP Orange Stimulator, flipping the active side of the MagVenture Cool-B70 coil
Treatment groups
68 Participants
are divided into 4 treatment groupsGroup A: Gamma burst rTMSActive comparator 1 intervention
Group B: Sham gamma burts rTMSSham comparator 1 intervention
Group C: Beta burst rTMSActive comparator 1 intervention
Group D: Sham beta burst rTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Unified Dyskinesia Rating Scale (UDysRS)
UDysRS utilizes rater information, patient self-report and objective measures of dyskinesia to provide assessments of impairment and disability due to dyskinesia.The UDysRS total score ranges from 0 to 104 with a lower score indicating less dyskinesia.
Time frame
Baseline (usual medication intake) and up to 40 minutes after taking 150 % of normal morning levodopa dose as Madopar Quick2
Dyskinesia onset time
The onset time of dyskinesia in minutes after levodopa administration
Time frame
Baseline (usual medication intake) and up to 40 minutes after taking 150 % of normal morning levodopa dose as Madopar QuickSecondary outcomes
1
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Measure the changes of scores of United Parkinson's Disease Rating Scale Part III in active stimulation compared to sham. The total scores range from 0 (good health) to 132 (poor health).
Time frame
Baseline (usual medication intake) and up to 40 minutes after taking 150 % of normal morning levodopa dose as Madopar QuickOther outcomes
1
TMS adverse events and associated sensations questionnaire (TMSens_Q)
Questionnaire for assessing any side effects and sensations associated with TMS stimulation, including the assessment of masking (sham or active treatment) of participants.
Time frame
Immediately after the TMS intervention (sham and active)2
Transcranial evoked potentials (TEPs)
Change in cortical excitability pre-post stimulation and OFF-ON states after levodopa administration
Time frame
Before and immediately after the TMS intervention (sham and active), up to 20 minutes after taking 150 % of normal morning levodopa dose as Madopar Quick3
Event related potentials (ERPs)
Dynamics of EEG during a Go/Nogo task: movement related potentials, spectral features
Time frame
Immediately after taking 150 % of normal morning levodopa dose as Madopar Quick4
Non-Motor Symptoms Scale for Parkinson's Disease (NMSS)
The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The scores on the NMSS range from 0 to 360, with higher scores implying a higher severity and frequency of nonmotor symptoms.
Time frame
Baseline, 4-8 weeks after inclusionSponsors and contacts
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Source ClinicalTrials.gov