Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583278
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
The Efficacy of Repetitive Transcranial Magnetic Stimulation in Parkinson39s DiseaseA Randomized Double-blind Multicenter Placebo-controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Repetitive Transcranial Magnetic Stimulation in Parkinson39s DiseaseA Randomized Double-blind Multicenter Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Repetitive transcranial magnetic stimulation rTMS is a non-invasive and widely used neuromodulation technology Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinsons diseasePD and delay the progression of the disease In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country
Detailed Description:
As an innovative non-invasive neuromodulation technology repetitive transcranial magnetic stimulation rTMS has demonstrated efficacy in improving motor symptoms in patients with Parkinsons disease PD The supplementary motor area SMA has been identified as a brain region significantly associated with motor symptoms in PD patients However no large-sample clinical studies have yet established the clinical efficacy of rTMS guided by neuroimaging navigation targeting the SMA in patients with Parkinsons disease
We describe a randomized controlled double-blind placebo-treated multicenter study designed to recruit 312 patients with idiopathic Parkinsons disease Participants will be randomly assigned to receive either real stimulation or sham stimulation with the left SMA undergoing 7 days of continuous theta burst stimulation cTBS The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinsons Disease Rating Scale MDS-UPDRS Part III scores from baseline to post-treatment and follow-up Secondary outcomes include changes in scores on other clinical symptom scales The study is expected to be conducted across nine medical centers in China commencing in 2024 and concluding in 2026
This study will evaluate the clinical efficacy of cTBS targeting the left SMA in patients with Parkinsons disease The findings may offer a new therapeutic approach for PD
We describe a randomized controlled double-blind placebo-treated multicenter study designed to recruit 312 patients with idiopathic Parkinsons disease Participants will be randomly assigned to receive either real stimulation or sham stimulation with the left SMA undergoing 7 days of continuous theta burst stimulation cTBS The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinsons Disease Rating Scale MDS-UPDRS Part III scores from baseline to post-treatment and follow-up Secondary outcomes include changes in scores on other clinical symptom scales The study is expected to be conducted across nine medical centers in China commencing in 2024 and concluding in 2026
This study will evaluate the clinical efficacy of cTBS targeting the left SMA in patients with Parkinsons disease The findings may offer a new therapeutic approach for PD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None