Low-frequency transcranial stimulation of pre-supplementary motor area alleviates levodopa-induced dyskinesia in Parkinson's disease: a randomized cross-over trial.
Allan Lohse, David Meder, Silas Nielsen...
https://pubmed.ncbi.nlm.nih.gov/33225277Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06570824
Network Based Repetitive Transcranial Magnetic Stimulation (rTMS) as an Intervention for Levodopa-induced Dyskinesia (LID) in Parkinson's Disease (PD)
Led by Danish Research Centre for Magnetic Resonance · Updated on 2024-08-28
68
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating repetitive transcranial magnetic stimulation (rTMS) as a treatment for levodopa-induced dyskinesia (LID) in people with Parkinson's Disease (PD). The study focuses on stimulating the pre-supplementary motor area (pre-SMA) to see if this can delay the start of dyskinesia after levodopa intake and reduce its severity. This research aims to identify the best rTMS targets, parameters, and understand the mechanisms behind LID in PD. Participants will receive rTMS bursts targeting the pre-SMA using a device called the MagVenture Cool-B70 coil. The study includes groups receiving real stimulation at gamma frequency (130Hz) or beta frequency (20Hz) and corresponding sham (inactive) stimulations for 30 minutes. The stimulation intensity and location will be optimized based on brain anatomy and electric field simulations. The study compares the effects of these different burst frequencies on LID symptoms. During the study, participants will be assessed using the Unified Dyskinesia Rating Scale (UDysRS) and monitored for the time dyskinesia begins after taking 150% of their usual morning levodopa dose. Movement symptoms will also be evaluated using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. A clinician unaware of the treatment group will perform ratings. The study follows a randomized, double-blind design and includes assessments up to 40 minutes after levodopa intake, with safety and response monitored throughout.
CONDITIONS
Brief Title
rTMS as an Intervention for Levodopa-induced Dyskinesia
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Clinically established or probable Parkinson's Disease
- Meet Clinical Diagnostic Criteria for Parkinson's Disease
- Experience peak-of-dose levodopa-induced dyskinesia
- On stable antiparkinsonian medication for at least four weeks
- Able and willing to provide signed informed consent
You will not qualify if you...
- Have psychiatric disorders
- Use antipsychotic medications, Donepezil, or GABAergic drugs like pregabalin and gabapentin
- Regularly use benzodiazepines or opioids more than once per week
- Have neurological diseases other than Parkinson's Disease
- History of epilepsy or increased seizure risk from TMS
- Have close relatives with epilepsy or seizure risk
- Contraindications for MRI scanning
- Female participants of childbearing age who are pregnant or not using contraception
- Refuse to be informed about new health-related information or accidental findings during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 30 minutes per session
Participants receive repetitive transcranial magnetic stimulation (rTMS) targeting the pre-supplementary motor area (pre-SMA) with either active or sham stimulation at gamma or beta burst frequencies to reduce levodopa-induced dyskinesia symptoms.
1 baseline visit and multiple treatment visits as per study schedule
Trial Site Locations
Total: 1 location
1
DRCMR
Hvidovre, Denmark, 2650
Actively Recruiting
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Research Team
L
Laura Sakalauskaite, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
The acute brain response to levodopa heralds dyskinesias in Parkinson disease.
Damian M Herz, Brian N Haagensen, Mark S Christensen...
https://pubmed.ncbi.nlm.nih.gov/24889498