Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422104
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-04-24
Brief Title:
Neuromodulation Therapy for Task-Specific Dystonia
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Development of Mechanistically Informed Therapy for Task-Specific Dystonia Using Noninvasive Neuromodulation
Status:
COMPLETED
Status Verified Date:
2024-05
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:
This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation rTMS in patients with focal hand dystonia FHD The goal of the study is to identify which cortical target premotor cortex PMC or primary somatosensory cortex PSC will show benefit after active rTMS compared to sham rTMS A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS The study will evaluate rTMS response using measures if writing on a sensor tablet examiner and patient dystonia rating scales and brain imaging scan functional MRI to understand brain changes after rTMS Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures
Detailed Description:
The primary objective of this study is to develop rTMS for FHD The focus is to assess whether stimulating the PMC or PSC will show greater improvement in writing behavior This research builds upon prior studies that have demonstrated improvement in behavior after rTMS to PMC and PSC The study includes five sequential visits
Visit 1 behavior writing measures and dystonia rating scales
Visit 2 includes task-based functional MRI brain scans to develop cortical target for rTMS sessions
Visits 3 4 and 5 FHD participants receive 10 Hz rTMS to PMC PSC and sham rTMS to PMC in a cross over design with at minimum one week of washout between sessions Participants complete behavior writing measures and rating scales on same day before and after each TMS session and an fMRI after each TMS session Up to 5 Healthy Volunteers were recruited to help develop the TMS visits
The information in this record reflects Visits 2-5
Visit 1 behavior writing measures and dystonia rating scales
Visit 2 includes task-based functional MRI brain scans to develop cortical target for rTMS sessions
Visits 3 4 and 5 FHD participants receive 10 Hz rTMS to PMC PSC and sham rTMS to PMC in a cross over design with at minimum one week of washout between sessions Participants complete behavior writing measures and rating scales on same day before and after each TMS session and an fMRI after each TMS session Up to 5 Healthy Volunteers were recruited to help develop the TMS visits
The information in this record reflects Visits 2-5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None