Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570824
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-03
Brief Title:
rTMS as an Intervention for Levodopa-induced Dyskinesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Network Based Repetitive Transcranial Magnetic Stimulation rTMS as an Intervention for Levodopa-induced Dyskinesia LID in Parkinsons Disease 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:
ADAPT-LIDI
Brief Summary:
The proposed study investigates the use of repetitive transcranial magnetic stimulation rTMS as a treatment for levodopa-induced dyskinesia LID in Parkinsons Disease PD Specifically the study aims to determine whether patterned stimulation of the pre-supplementary motor area pre-SMA can delay the onset of LID after levodopa intake and reduce LID severity in PD patients This study will provide critical insights into potential targets for rTMS treatment optimal rTMS parameters and the mechanisms underlying LID in Parkinsons disease
Detailed Description:
Long-term use of levodopa in Parkinsons Disease PD often leads to motor complications such as Levodopa-Induced Dyskinesia which significantly impacts patients daily lives Various brain regions have been targeted for treatment with Transcranial Magnetic Stimulation TMS including the supplementary motor area SMA primary motor cortex cerebellum and prefrontal cortex Specifically targeting the pre-SMA with 1-Hz rTMS has been shown to delay and reduce dyskinesia severity in PD patients following levodopa administration These findings suggest that the pre-supplementary motor area is a promising target for brain stimulation therapy as it plays a causal role in the pathophysiology of peak-of-dose dyskinesia
The current study aims to build on previous research by optimizing the stimulation intensity and location based on individual neuroanatomy and simulated electric fields Additionally the study will explore the impact of rTMS delivered in short high-frequency bursts differing from the single rTMS pulses used in previous studies In the context of LID Deep Brain Stimulation DBS typically targets the subthalamic nucleus STN using gamma frequencies 40-200 Hz most commonly 130 Hz Drawing from this principle the study posits that delivering rTMS bursts at gamma frequencies to the pre-SMA will effectively mitigate LID symptoms Moreover evidence from cortical brain rhythm recordings highlights that beta frequencies 12-30 Hz which are crucial for movement control and are disrupted in PD may also hold therapeutic potential Therefore the study will investigate whether rTMS bursts at beta frequencies could similarly reduce LID symptoms Given the absence of prior research directly comparing the effects of different burst frequencies on LID the study will systematically apply two distinct burst frequencies in separate patient groups to determine which if either produces a meaningful reduction in LID symptoms
Dyskinesia onset time and severity will be measured using the Unified Dyskinesia Rating Scale UDysRS and assessed by a clinician rater who is blinded to the treatment condition The results will be compared between the active and sham stimulation conditions
The current study aims to build on previous research by optimizing the stimulation intensity and location based on individual neuroanatomy and simulated electric fields Additionally the study will explore the impact of rTMS delivered in short high-frequency bursts differing from the single rTMS pulses used in previous studies In the context of LID Deep Brain Stimulation DBS typically targets the subthalamic nucleus STN using gamma frequencies 40-200 Hz most commonly 130 Hz Drawing from this principle the study posits that delivering rTMS bursts at gamma frequencies to the pre-SMA will effectively mitigate LID symptoms Moreover evidence from cortical brain rhythm recordings highlights that beta frequencies 12-30 Hz which are crucial for movement control and are disrupted in PD may also hold therapeutic potential Therefore the study will investigate whether rTMS bursts at beta frequencies could similarly reduce LID symptoms Given the absence of prior research directly comparing the effects of different burst frequencies on LID the study will systematically apply two distinct burst frequencies in separate patient groups to determine which if either produces a meaningful reduction in LID symptoms
Dyskinesia onset time and severity will be measured using the Unified Dyskinesia Rating Scale UDysRS and assessed by a clinician rater who is blinded to the treatment condition The results will be compared between the active and sham stimulation conditions
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