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
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