Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350617
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-02-27
Brief Title:
Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation rTMS therapy based on the functional reserve of each patient with Parkinsons disease compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex M1 Investigators hypothesized that the functional reserve of each patient with Parkinsons disease will be different and therefore an appropriate simulating target for rTMS therapy is needed In addition this approach could be more effective compared to conventional protocols applied to patient with Parkinsons disease regardless of their severity predicted mechanism of motor function recovery or functional reserves
Detailed Description:
rTMS treatment for patients with Parkinsons disease is traditionally based on stimulating the neural network of brain The widely-used traditional rTMS treatment protocol involves high-frequency stimulation over the bilateral primary motor cortex M1 to enhance motor and gait functions However concerns have arisen regarding the effect of rTMS on motor recovery in patients with Parkinsons disease Although still subject to debate a possible reason for the diverse results of rTMS applied is the uniform application protocol to individuals with varying pathologies and functional reserves aimed at enhancing recovery
Therefore this study was aimed to determine the effects of protocols of rTMS therapy based on the functional reserve of each patient with Parkinsons disease
Based on screening evaluations Timed Up and Go Test TUG Timed Up and Go Dual Task-Cognitive TUG-Cog investigators hypothesized that patients could be categorized into two groups 1 priority in motor functional reserve 2 priority in cognitive functional reserve For each group investigators plan to randomly assign patients to experimental and control groups to demonstrate the efficacy of different rTMS protocols based on functional reserves compared to conventional high-frequency rTMS applied to the bilateral M1
Therefore this study was aimed to determine the effects of protocols of rTMS therapy based on the functional reserve of each patient with Parkinsons disease
Based on screening evaluations Timed Up and Go Test TUG Timed Up and Go Dual Task-Cognitive TUG-Cog investigators hypothesized that patients could be categorized into two groups 1 priority in motor functional reserve 2 priority in cognitive functional reserve For each group investigators plan to randomly assign patients to experimental and control groups to demonstrate the efficacy of different rTMS protocols based on functional reserves compared to conventional high-frequency rTMS applied to the bilateral M1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None