Viewing Study NCT06542991



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06542991
Status: RECRUITING
Last Update Posted: None
First Post: 2024-08-03

Brief Title: An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
Sponsor: None
Organization: None

Study Overview

Official Title: An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
Status: RECRUITING
Status Verified Date: 2024-08
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: To demonstrate that intervention targeting the supplementary motor area SMA using precise navigation positioning can effectively improve motor symptoms in patients with Parkinsons disease
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 open-lable study designed to recruit 20 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

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