NCT06365190

Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD.

Detailed description

This was a open-label clinical trial to assess the Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease. Participants were randomly assigned to the cTBS group and the control group on a 1:1 basis using age as a stratification factor. In the cTBS group, after baseline assessment, participants received cTBS treatment on the left supplementary motor area(SMA) for 14 days, and symptoms were assessed on the second day after treatment. Ten weeks after completion of assessment, a second cTBS session was performed, with all patients taking stable doses of antiparkinsonian medications. The control group only received drug intervention, and symptom assessment was conducted at weeks 13, 23 , 33 , and 43. To rule out the influence of medication on symptom assessment, all patients stopped taking medication for at least 12 hours before assessment.

Conditions

• Transcranial Magnetic Stimulation
• Parkinson's Disease

Interventions

Type	Name	Description
OTHER	transcranial magnetic stimulation	During treatment, the patient underwent cTBS targeting the left SMA for 14 consecutive days. Each treatment day comprised three rounds of cTBS, with a 15-minute interval between each. A single cTBS session involved trains of three pulses at 50 Hz, repeated every 200 ms (5 Hz), until reaching a total of 600 pulses, lasting 40s. Stimulation intensity remained at 80% of resting motor threshold. In total, patients received 25,200 pulses throughout the treatment period.
DRUG	Pharmacotherapy（antiparkinsonian drugs）	Anti-Parkinson's disease drugs include compound levodopa, dopamine receptor agonists, monoamine oxidase type B inhibitors, catechol-O-methyl transferase inhibitors, etc. Take dopaminergic agents regularly, with follow-up every 8 weeks including medication guidance and symptom assessment

Timeline

• Start date: 2020-04-06
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2024-04-15
• Last updated: 2024-04-16

Locations

1 site across 1 country: China